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Solid TumorsPhase 1/2NCT00147225

AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

A Phase 1/2 study testing AMG 531, Carboplatin and Adriamycin in people with Solid Tumors and Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site 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 goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Advanced Cancer
What is being tested?
AMG 531, Carboplatin and Adriamycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Aug 2005to Mar 2013
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

  • Patients with a diagnosis of solid tumors who are at high risk for chemotherapy-induced severe thrombocytopenia related to the following regimens: (a) Carboplatin (AUC=11); (b) AI regimen (adriamycin 75-90mg/m2, Ifosfamide 10gm/m2); (c) High dose Ifosfamide (14gm/m2)
  • Age >/= 18 years.
  • Adequate hematologic (Absolute neutrophil count (ANC) >/= 1500/mm^3, platelet count >/= 100 x 10^9/L and Hgb >/= 8 gm/dL), renal (serum creatinine </= 2.0 mg/dL), and hepatic functions (total bilirubin </= 2 times, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) </= 3 times the upper limit of the respective normal range).
  • Karnofsky Performance Status >/= 80
  • Signed informed consent form
  • Patients with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) must have a negative pregnancy test and use adequate birth control. [i.e. oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD), or abstinence].

Who cannot join

  • Patients with rapidly progressive disease (such as patients with rapidly accumulating ascites or pleural effusion).
  • Patients with hematologic malignancies.
  • Pregnant or lactating women.
  • History of central nervous system (CNS) metastasis.
  • Patients with significant cardiac disease (New York Hearth Association (NYHA) Class III or IV), dysrrhythmia, or recent history of MI or ischemia, transient ischemic attack or cerebrovascular accident (CVA), within the previous 6 months of study entry.
  • Patients with a history of thromboembolic events (history of deep venous thrombosis (DVT) or pulmonary embolus).
Show all 15Show fewer
  • Prior chemotherapy, immunotherapy, or experimental drug (not FDA-approved drug) within 3 weeks. Patients will be eligible if day 1 of chemotherapy was initiated 3 weeks prior to study entry if the patient has recovery of blood counts and from acute toxicity of chemotherapy as described in inclusion criteria # 3.
  • Use of nitrosourea (carmustine (BCNU), lomustine (CCNU) or mitomycin - C within 6 weeks of study entry.
  • Prior surgery or Radiation Therapy (RT) within 2 weeks of study entry.
  • Patients with history of prior whole pelvic radiation will be excluded unless there is no prior history of severe thrombocytopenia (i.e. platelet nadir <10,000/mm^3)
  • Patients with history of prior high dose chemotherapy with stem cell transplant or with history of prolonged thrombocytopenia (>/= 2 weeks).
  • History of any platelet disorders including Idiopathic thrombocytopenic purpura (ITP), Thrombotic thrombocytopenic purpura (TTP) or bleeding disorders.
  • History of > 4 prior chemotherapy regimens (all platinum regimens will be counted as one regimen).
  • Patients with significant bowel dysfunction secondary to tumor (significant abdominal pain with severe constipation/diarrhea (>/= Grade 3), significant difficulty maintaining oral nutrition).
  • Patients with pre-existing neuropathy > Grade 2.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim).

Primary Objectives:

Read more
  1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy
  2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia
  3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy

Secondary Objective:

  1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy
Read the detailed description

Platelets are cells that help make the blood clot. A decrease in platelets can cause bleeding, which may prevent or delay a patient from receiving chemotherapy. Researchers want to find out if AMG 531 can lower the risk and severity of this side effect. AMG 531 is a protein that stimulates platelet production.

If you are eligible to take part in this study, you will be assigned to 1 of 6 dosing schedules of study drug. The dose of AMG 531 that you receive will depend on when you are enrolled.

In Cycle 1, all patients will receive chemotherapy by itself. Three (3) weeks later, in Cycle 2, the same dose of chemotherapy will be given followed by AMG 531. AMG 531 will be given on one of 3 schedules. AMG 531 will be given as an injection under the skin on the day after chemotherapy and 2 days later; it will be given 5 days before and the day after chemotherapy; or it will be given 5 and 3 days before chemotherapy and on the day after chemotherapy and 2 days later. The schedule you receive will depend on when you enroll on the study. After 2 cycles of treatment, based on response of the disease and tolerance to the treatment, all participants may be able to receive up to 4 more cycles of chemotherapy followed by AMG 531. All participants will continue on the same schedule you were receiving before. The dose of AMG 531 may be increased at one time point during the study based on the response of the platelet counts.

The number of blood tests drawn (about 3 teaspoons each) will depend on your clinical condition. These samples will be taken at least 2 times a week and as often as once a day during portions of the study. You will also have blood (about 1 teaspoon) collected for the evaluation of anti-AMG 531 antibody status before treatment starts, at the end of Cycles 2 and 4, and at the end of study.

You will be taken off the study if your disease gets worse or intolerable side effects occur. At the end of the study, you will have a medical history and physical exam, including measurement of vital signs. You will also have blood (about 1 teaspoon) drawn for routine tests.

This is an investigational study. AMG 531 is not FDA approved or commercially available. At this time, it is being used for research purposes only. Up to 56 patients will take part in this study. All will be enrolled at University of Texas (UT)MD Anderson.

Being tested
AMG 531, Carboplatin, Adriamycin, Ifosfamide
Keywords
Advanced Cancer, Advanced Malignancy, Solid Tumors, Thrombocytopenia, AMG 531, Romiplostim, Carboplatin, Paraplatin, Platelets, Adriamycin, Doxorubicin, Rubex, Ifosfamide, Ifex
Medical subject headings
Thrombocytopenia

What participants receive

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

  • AMG 531Drug

    Also called Romiplostim

    Beginning with Cycle 2, administered in one of two schedules, either on day after chemotherapy and 2 days later (study cycle) or on day -5 (pre dose) and on day after chemotherapy (post dose) or combination of pre/post days of 21-28 day treatment cycle. Combination if Optimal biological dose (OBD) not reached, additional treatment at 10 mcg/kg dose level, with AMG 531 administered on day -5 (pre dose) and on day after chemotherapy (post dose).

    1, 3, or 10 mcg/kg given as injection under the skin (subcutaneous)

  • CarboplatinDrug

    Also called Paraplatin

    AUC=11; Cycle 1 chemotherapy alone then 3 weeks later, in Cycle 2, same dose of chemotherapy followed by AMG 531.

  • AdriamycinDrug

    Also called Doxorubicin, Rubex

    75-90 mg/m^2 IV

  • IfosfamideDrug

    Also called Ifex

    10 gm/m^2 IV; OR, High dose ifosfamide = 14 gm/m^2.

Study groups in NCT00147225
Study groupRoleWhat they receive
1 mcg/kg AMG 531 Post ChemotherapyExperimentalCycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle. Chemotherapy : 1. Carboplatin [area under the concentration curve (AUC) = 11]; or 2. Adriamycin - Ifosfamide (AI) regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or 3. High dose Ifosfamide: 14 gm/m^2.
Receives: Drug: AMG 531; Drug: Carboplatin; Drug: Adriamycin; Drug: Ifosfamide
3 mcg/kg AMG 531 Post ChemotherapyExperimentalCycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle. Chemotherapy : 1. Carboplatin [area under the concentration curve (AUC) = 11]; or 2. AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or 3. High dose Ifosfamide: 14 gm/m^2.
Receives: Drug: AMG 531; Drug: Carboplatin; Drug: Adriamycin; Drug: Ifosfamide
10 mcg/kg AMG 531 Post ChemotherapyExperimentalCycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle. Chemotherapy : 1. Carboplatin [area under the concentration curve (AUC) = 11]; or 2. AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or 3. High dose Ifosfamide: 14 gm/m^2.
Receives: Drug: AMG 531; Drug: Carboplatin; Drug: Adriamycin; Drug: Ifosfamide
10 mcg/kg Pre/Post ChemotherapyExperimentalCycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle. Chemotherapy : 1. Carboplatin [area under the concentration curve (AUC) = 11]; or 2. AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or 3. High dose Ifosfamide: 14 gm/m^2.
Receives: Drug: AMG 531; Drug: Carboplatin; Drug: Adriamycin; Drug: Ifosfamide
5 mcg/kg AMG 531 Pre/Pre/Post/Post ChemotherapyExperimentalCycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle. Chemotherapy : 1. Carboplatin [area under the concentration curve (AUC) = 11]; or 2. AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or 3. High dose Ifosfamide: 14 gm/m^2.
Receives: Drug: AMG 531; Drug: Carboplatin; Drug: Adriamycin; Drug: Ifosfamide
10 mcg/kg AMG 531 Pre/Pre/Post/Post ChemotherapyExperimental10 mcg/kg AMG 531 + Pre/Pre/Post/Post Chemotherapy Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle. Chemotherapy : 1. Carboplatin [area under the concentration curve (AUC) = 11]; or 2. AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or 3. High dose Ifosfamide: 14 gm/m^2.
Receives: Drug: AMG 531; Drug: Carboplatin; Drug: Adriamycin; Drug: Ifosfamide

What is being measured

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

  1. Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy

    Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.

    Measured: Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles

  2. Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy

    Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.

    Measured: Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles

Timeline

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

  1. First posted7 Sep 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147225
Sponsor's protocol ID
2005-0099
Status last verified
Apr 2014
First submitted
6 Sep 2005
Last updated
8 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 531, Carboplatin and Adriamycin in people with Solid Tumors and Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site 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 6 inclusion and 15 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 8 May 2014). 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?

Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy (time frame: Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles). 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 NCT00147225.

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 8 May 2014.

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