Ovarian CancerPhase 1/2NCT00531284

Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma

A Phase 1/2 study testing Carfilzomib and Dexamethasone in people with Ovarian Cancer and Renal Cancer, run by Amgen at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of this Phase 1b/2 study were as follows: Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ovarian Cancer, Renal Cancer, Non-small Cell Lung Cancer
What is being tested?: Carfilzomib and Dexamethasone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 7 sitesUnited States
Study dates: Sep 2007to 22 May 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Disease related
Phase 1 Subjects (Bolus and Infusion):
Solid Tumor:
Histologically confirmed advanced solid tumor
1 to 3 prior treatment regimens
At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computed tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor

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Multiple Myeloma (MM):
Relapsed and/or refractory multiple myeloma following 2 or more prior treatment regimens.
Measurable disease as indicated by one or more of the following:
Serum M-protein ≥ 1 g/dL
Urine M-protein ≥ 200 mg/24 hr
Serum Free Light Chain: Involved free light chain (FLC) level ≥ 10 mg/dL provided serum FLC ratio is abnormal
Lymphoma:
Histologically or cytologically confirmed lymphoma.
Patients must have had an initial diagnosis of indolent non-Hodgkin lymphoma (NHL) (including follicular, small lymphocytic, lymphoplasmacytoid, and marginal zone lymphoma), indolent disease that transformed to a more aggressive subtype, as previously described or patients may have mantle cell lymphoma.
Patients are required to have received prior rituximab (alone or combined with other treatment) and are considered refractory to (defined as no response, or progression within 6 months of completing therapy) or intolerant of continued rituximab.
Patients may have received up to a maximum of four prior unique chemotherapy regimens, including if not contra-indicated autologous stem-cell transplantation (ASCT).
For patients to enroll in the expanded dose group for lymphoma, patients must have measurable disease
Phase 2 Bolus Subjects:
-Histologically confirmed advanced solid tumor diagnosis and:
Non-small cell lung cancer (NSCLC): Failed at least 1 prior platinum-based chemotherapy regimen but not more than 3 prior therapies for metastatic disease
Small cell lung cancer (SCLC): Failed 1 to 3 prior chemotherapy regimens
Ovarian: Failed at least 1 prior platinum-based chemotherapy regimen but not more than 4 therapies for metastatic disease
Renal: Failed at least 2 prior chemotherapy regimens for metastatic disease
Other solid tumor types: Failed at least 1 prior chemotherapy regimen for metastatic or relapsed disease and for which standard of care therapy is no longer effective or does not exist
At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional CT scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor
Demographic
Males and females ≥ 18 years of age
Life expectancy of more than 3 months
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Laboratory
Adequate hepatic function, with bilirubin 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) 3 times ULN
Absolute neutrophil count (ANC) > 1000/mm³, hemoglobin ≥ 8 gm/dL for solid tumors or 7.0 gm/dL for MM, and platelet count ≥ 100,000/mm³ for solid tumors or ≥ 30,000/mm³ for MM.
Subjects should not have received platelet transfusions for at least 1 week prior to screening
Screening ANC should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for ≥ 2 weeks
Subjects may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
Calculated or measured creatinine clearance (CrCl) of ≥ 20 mL/minute calculated using the formula of Cockcroft and Gault. Subjects with calculated CrCl < 20 mL/min may be allowed, only with prior approval by the Medical Monitor.
Ethical/Other
Written informed consent in accordance with federal, local, and institutional guidelines
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose and agree to use dual methods of contraception during the study and for 3 months following the last dose of study drug. Post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.

Who cannot join

Disease Related
Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose or 6 weeks for antibody therapy
Radiation therapy or immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required); localized radiation therapy within 1 week prior to first dose
Subjects with prior brain metastases are permitted, but must have completed treatment and have no evidence of active central nervous system (CNS) disease for at least 4 weeks prior to first dose
For lymphoma patients; patients with prior stem cell transplant therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-versus-host disease (GVHD)
Evidence of CNS lymphoma

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Participation in an investigational therapeutic study within 3 weeks prior to first dose
Prior treatment with carfilzomib
Concurrent Conditions
Major surgery within 3 weeks prior to first dose
Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 3 months prior to first dose
Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
Known or suspected human immunodeficiency virus (HIV) infection or subjects who are HIV seropositive
Active hepatitis A, B, or C infection
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
Subjects with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis
Subjects at risk* in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment
High risk for Tumor Lysis Syndrome.
Ethical / Other
Female subjects who are pregnant or lactating
Any clinically significant psychiatric or medical condition that in the opinion of the Investigator could interfere with protocol adherence or a subject's ability to give informed consent

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Tower Cancer Research Foundation
Beverly Hills, California, 90210
Northwestern University
Chicago, Illinois, 60611
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203-1632
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
Pinnacle Oncology
Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: Phase 1b/2, Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors, Multiple Myeloma or Lymphoma

The primary objectives of this Phase 1b/2 study were as follows:

Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma.
Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of carfilzomib in patients with relapsed solid tumors.

Conditions: Ovarian Cancer, Renal Cancer, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Multiple Myeloma
Being tested: Carfilzomib, Dexamethasone
Keywords: Non-small cell lung carcinoma, Small-cell lung carcinoma, Ovarian Cancer, Renal Cancer, Other solid tumors, multiple myeloma, lymphoma
Medical subject headings: Ovarian Neoplasms, Kidney Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Multiple Myeloma, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CarfilzomibDrug
Also called Kyprolis
Administered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion
DexamethasoneDrug
Administered orally or by IV infusion prior to carfilzomib

Study groups in NCT00531284
Study group	Role	What they receive
Phase 1B Solid Tumors: Carfilzomib 20 mg/m² Bolus	Experimental	Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/27 mg/m² Bolus	Experimental	Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/36 mg/m² Bolus	Experimental	Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 2 Solid Tumors: Carfilzomib 20/36 mg/m² Bolus	Experimental	Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 36 mg/m²	Experimental	Participants received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 45 mg/m²	Experimental	Participants received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/45 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/56 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1B Solid Tumors: Carfilzomib 20/70 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1b Multiple Myeloma: Carfilzomib 20/36 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1b Multiple Myeloma: Carfilzomib 20/45 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1b Multiple Myeloma: Carfilzomib 20/56 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1b Multiple Myeloma: Carfilzomib 20/70 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1b Lymphoma: Carfilzomib 20/56 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1b Lymphoma: Carfilzomib 20/70 mg/m²	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib
Phase 1b MM: Carfilzomib 20/45 mg/m² + Dexamethasone	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib; Drug: Dexamethasone
Phase 1b MM: Carfilzomib 20/56 mg/m² + Dexamethasone	Experimental	Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity. Receives: Drug: Carfilzomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)
Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding.
The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle.
Measured: 28 days
Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles
Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: Disappearance of all target and non-target lesions and no new lesions;
PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions.
Measured: 4 months

Secondary outcomes (12)

Percentage of Participants With an Overall Response Throughout the Study
Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM.
Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.
Measured: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Duration of Response
Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.
Measured: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Progression-Free Survival
Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.
Measured: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Time to Progression
Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.
Measured: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Maximum Observed Plasma Concentration of Carfilzomib
Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Elimination Half-life (t½) of Carfilzomib
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Clearance (CL) of Carfilzomib
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Volume of Distribution at Steady State (Vss) of Carfilzomib
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib
Measured: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 200722 May 2017

First posted18 Sep 2007 (estimated)
Study startSep 2007
Primary completionOct 2014
Study completion22 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00531284
Sponsor's protocol ID: PX-171-007
Status last verified: Jul 2017
First submitted: 14 Sep 2007
Last updated: 15 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Papadopoulos KP, Siegel DS, Vesole DH, Lee P, Rosen ST, Zojwalla N, Holahan JR, Lee S, Wang Z, Badros A. Phase I study of 30-minute infusion of carfilzomib as single agent or in combination with low-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma. J Clin Oncol. 2015 Mar 1;33(7):732-9. doi: 10.1200/JCO.2013.52.3522. Epub 2014 Sep 15.
PubMed 25225420
Ohshima-Hosoyama S, Davare MA, Hosoyama T, Nelon LD, Keller C. Bortezomib stabilizes NOXA and triggers ROS-associated apoptosis in medulloblastoma. J Neurooncol. 2011 Dec;105(3):475-83. doi: 10.1007/s11060-011-0619-0. Epub 2011 Jun 3.
PubMed 21633906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b/2, Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors, Multiple Myeloma or Lymphoma
ClinicalTrials.gov ID: NCT00531284
Acronym / sponsor ID: PX-171-007
Conditions: Ovarian Cancer, Renal Cancer, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Multiple Myeloma
Keywords: Non-small cell lung carcinoma, Small-cell lung carcinoma, Ovarian Cancer, Renal Cancer, Other solid tumors, multiple myeloma, lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Oct 2014 (actual)
Study completion: 22 May 2017 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 9 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objectives of this Phase 1b/2 study were as follows:

Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma.
Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of carfilzomib in patients with relapsed solid tumors.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 17

Arm	Type	Receives
Phase 1B Solid Tumors: Carfilzomib 20 mg/m² Bolus	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1B Solid Tumors: Carfilzomib 20/27 mg/m² Bolus	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1B Solid Tumors: Carfilzomib 20/36 mg/m² Bolus	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 2 Solid Tumors: Carfilzomib 20/36 mg/m² Bolus	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1B Solid Tumors: Carfilzomib 36 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1B Solid Tumors: Carfilzomib 45 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1B Solid Tumors: Carfilzomib 20/45 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1B Solid Tumors: Carfilzomib 20/56 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1B Solid Tumors: Carfilzomib 20/70 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b Multiple Myeloma: Carfilzomib 20/36 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b Multiple Myeloma: Carfilzomib 20/45 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b Multiple Myeloma: Carfilzomib 20/56 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b Multiple Myeloma: Carfilzomib 20/70 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b Lymphoma: Carfilzomib 20/56 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b Lymphoma: Carfilzomib 20/70 mg/m²	Experimental	Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b MM: Carfilzomib 20/45 mg/m² + Dexamethasone	Experimental	Drug: Carfilzomib, Drug: DexamethasoneParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
Phase 1b MM: Carfilzomib 20/56 mg/m² + Dexamethasone	Experimental	Drug: Carfilzomib, Drug: DexamethasoneParticipants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (40 listed)

Disease related
Histologically confirmed advanced solid tumor
1 to 3 prior treatment regimens
At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computed tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor
Relapsed and/or refractory multiple myeloma following 2 or more prior treatment regimens.

Key exclusion criteria (21 listed)

Disease Related
Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose or 6 weeks for antibody therapy
Radiation therapy or immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required); localized radiation therapy within 1 week prior to first dose
Subjects with prior brain metastases are permitted, but must have completed treatment and have no evidence of active central nervous system (CNS) disease for at least 4 weeks prior to first dose
For lymphoma patients; patients with prior stem cell transplant therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-versus-host disease (GVHD)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CarfilzomibAlso: KyprolisAdministered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion	Drug	Phase 1B Solid Tumors: Carfilzomib 20 mg/m² Bolus, Phase 1B Solid Tumors: Carfilzomib 20/27 mg/m² Bolus, Phase 1B Solid Tumors: Carfilzomib 20/36 mg/m² Bolus, Phase 1B Solid Tumors: Carfilzomib 20/45 mg/m², Phase 1B Solid Tumors: Carfilzomib 20/56 mg/m², Phase 1B Solid Tumors: Carfilzomib 20/70 mg/m², Phase 1B Solid Tumors: Carfilzomib 36 mg/m², Phase 1B Solid Tumors: Carfilzomib 45 mg/m², Phase 1b Lymphoma: Carfilzomib 20/56 mg/m², Phase 1b Lymphoma: Carfilzomib 20/70 mg/m², Phase 1b MM: Carfilzomib 20/45 mg/m² + Dexamethasone, Phase 1b MM: Carfilzomib 20/56 mg/m² + Dexamethasone, Phase 1b Multiple Myeloma: Carfilzomib 20/36 mg/m², Phase 1b Multiple Myeloma: Carfilzomib 20/45 mg/m², Phase 1b Multiple Myeloma: Carfilzomib 20/56 mg/m², Phase 1b Multiple Myeloma: Carfilzomib 20/70 mg/m², Phase 2 Solid Tumors: Carfilzomib 20/36 mg/m² Bolus
DexamethasoneAdministered orally or by IV infusion prior to carfilzomib	Drug	Phase 1b MM: Carfilzomib 20/45 mg/m² + Dexamethasone, Phase 1b MM: Carfilzomib 20/56 mg/m² + Dexamethasone

Primary outcome

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)
Time frame: 28 days
Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding. The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle.
Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles
Time frame: 4 months
Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target and non-target lesions and no new lesions; PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions.

12 secondary outcomes

Percentage of Participants With an Overall Response Throughout the Study
Time frame: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Duration of Response
Time frame: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Progression-Free Survival
Time frame: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Time to Progression
Time frame: Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
Maximum Observed Plasma Concentration of Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Elimination Half-life (t½) of Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Clearance (CL) of Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Volume of Distribution at Steady State (Vss) of Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib
Time frame: Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.

Results and safety

Results posted to the registry on 9 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P1B ST: CFZ 20 mg/m² Bolus	3	0
P1B ST: CFZ 20/27 mg/m² Bolus	4	0
P1B ST: CFZ 20/36 mg/m² Bolus	7	1
P2 ST: CFZ 20/36 mg/m² Bolus	65	2
P1B ST: CFZ 36 mg/m²	6	0
P1B ST: CFZ 45 mg/m²	7	0
P1B ST: CFZ 20/45 mg/m²	6	0
P1B ST: CFZ 20/56 mg/m²	10	0
P1B ST: CFZ 20/70 mg/m²	11	0
P1B MM: CFZ 20/36 mg/m²	4	0
P1B MM: CFZ 20/45 mg/m²	3	0
P1b MM: CFZ 20/56 mg/m²	24	0
P1B MM: CFZ 20/70 mg/m²	2	0
P1B LYM: CFZ 20/56 mg/m²	3	0
P1B LYM: CFZ 20/70 mg/m²	7	3
P1B MM: CFZ 20/45 mg/m² + Dex	14	2
P1B MM: CFZ 20/56 mg/m² + Dex	8	0

Primary outcome: Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)

Time frame: 28 days. Number. Unit: participants

Measure	P1B ST: CFZ 20 mg/m² Bolus n = 3	P1B ST: CFZ 20/27 mg/m² Bolus n = 3	P1B ST: CFZ 20/36 mg/m² Bolus n = 6	P1B ST: CFZ 36 mg/m² n = 6	P1B ST: CFZ 45 mg/m² n = 6	P1B ST: CFZ 20/45 mg/m² n = 6	P1B ST: CFZ 20/56 mg/m² n = 3	P1B ST: CFZ 20/70 mg/m² n = 6	P1B MM: CFZ 20/36 mg/m² n = 4	P1B MM: CFZ 20/45 mg/m² n = 3	P1b MM: CFZ 20/56 mg/m² n = 6	P1B MM: CFZ 20/70 mg/m² n = 2	P1B LYM: CFZ 20/56 mg/m² n = 3	P1B LYM: CFZ 20/70 mg/m² n = 7
Value	0	0	1	0	2	0	0	1	0	0	1	2	0	1

Population analysed: Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.

Primary outcome: Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles

Time frame: 4 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	P2 ST: CFZ 20/36 mg/m² Bolus n = 65
Value	15.4 (7.6 to 26.5)

Population analysed: Phase 2 Safety population

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P1B ST: CFZ 20 mg/m² Bolus	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
P1B ST: CFZ 20/27 mg/m² Bolus	1 of 4 (25%)	4 of 4 (100%)	Not reported
P1B ST: CFZ 20/36 mg/m² Bolus	4 of 7 (57.1%)	7 of 7 (100%)	Not reported
P2 ST: CFZ 20/36 mg/m² Bolus	27 of 65 (41.5%)	65 of 65 (100%)	Not reported
P1B ST: CFZ 36 mg/m²	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
P1B ST: CFZ 45 mg/m²	4 of 7 (57.1%)	7 of 7 (100%)	Not reported
P1B ST: CFZ 20/45 mg/m²	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
P1B ST: CFZ 20/56 mg/m²	5 of 10 (50%)	10 of 10 (100%)	Not reported
P1B ST: CFZ 20/70 mg/m²	6 of 11 (54.5%)	11 of 11 (100%)	Not reported
P1B MM: CFZ 20/36 mg/m²	2 of 4 (50%)	4 of 4 (100%)	Not reported
P1B MM: CFZ 20/45 mg/m²	0 of 3 (0%)	3 of 3 (100%)	Not reported
P1B MM: CFZ 20/56 mg/m²	11 of 24 (45.8%)	24 of 24 (100%)	Not reported
P1B MM: CFZ 20/70 mg/m²	2 of 2 (100%)	2 of 2 (100%)	Not reported
P1B LYM: CFZ 20/56 mg/m²	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
P1B LYM: CFZ 20/70 mg/m²	5 of 7 (71.4%)	7 of 7 (100%)	Not reported
P1B MM: CFZ 20/45 mg/m² + Dex	5 of 14 (35.7%)	14 of 14 (100%)	Not reported
P1B MM: CFZ 20/56 mg/m² + Dex	3 of 8 (37.5%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25225420Papadopoulos KP, Siegel DS, Vesole DH, Lee P, Rosen ST, Zojwalla N, Holahan JR, Lee S, Wang Z, Badros A. Phase I study of 30-minute infusion of carfilzomib as single agent or in combination with low-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma. J Clin Oncol. 2015 Mar 1;33(7):732-9. doi: 10.1200/JCO.2013.52.3522. Epub 2014 Sep 15.
Derived from this study: PubMed 21633906Ohshima-Hosoyama S, Davare MA, Hosoyama T, Nelon LD, Keller C. Bortezomib stabilizes NOXA and triggers ROS-associated apoptosis in medulloblastoma. J Neurooncol. 2011 Dec;105(3):475-83. doi: 10.1007/s11060-011-0619-0. Epub 2011 Jun 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carfilzomib and Dexamethasone in people with Ovarian Cancer and Renal Cancer, run by Amgen at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00531284, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.