Advanced MalignancyPhase 1NCT00974896
QUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid Tumors
A Phase 1 study testing AMG 479 in people with Advanced Malignancy and Advanced Solid Tumors, run by NantCell, Inc..
Trial summary
To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib, or gemcitabine in subjects with advanced solid tumors. Up to 126 subjects may be enrolled. Sorafenib and erlotinib combo cohorts are enrolling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancy, Advanced Solid Tumors, Cancer
- What is being tested?
- AMG 479
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
- Men and women ≥ 18 years old with a pathologically or cytologically documented, advanced solid tumor that is refractory to at least one line of therapy or for whom no standard therapy is available and for which no curative therapy is available, or the subject refuses standard non-curative therapy
- Measurable disease or evaluable disease per World Health Organization (WHO) guidelines
- Eastern Cooperative Oncology Group performance status ≤ 2
- Life expectancy of 3 months as documented by the investigator
- Adequate hematologic, renal and hepatic function
Who cannot join
- Any co-morbid medical condition that would increase the risk of toxicity in the opinion of Investigator or Sponsor
- Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia
- Subjects with primary or metastatic central nervous system (CNS) tumors are not allowed to enroll in the sorafenib cohorts. These subjects are allowed to enroll in the remaining cohorts, only if their CNS tumors have been controlled by prior surgery or radiation, and they have been neurologically stable
- History of lymphoma, leukemia, or high-dose chemotherapy with hematopoietic stem cell rescue
- Uncontrolled hypertension [diastolic >100 mmHg or systolic >150 mmHg]; Subjects enrolling in the sorafenib groups must not have diastolic > 85 mmHg nor systolic > 145 mmHg
- Clinically significant ECG changes which obscure the ability to assess the PR, QT, QRS intervals
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- Presence of ascites or pleural effusion requiring chronic medical intervention
- Diagnosis of arterial or venous thrombosis within 6 months before enrollment; history of bleeding diathesis
- History of clinically significant hypoglycemia or hyperglycemia in the opinion of the investigator
- Myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association >class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- Active peptic ulcer disease
- History of chronic hepatitis
- Subject known to have tested positive for HIV
- Known sensitivity to mammalian derived products
- Hematological function, as follows:
- Absolute neutrophil count (ANC) ≤ 1.5 x 109/L for B, P, S and E cohorts
- Absolute neutrophil count (ANC) ≤ 3 x 109/L for G cohorts
- Platelet count ≤ 100 x 109/L
- Hemoglobin ≤ 9 g/dL
- Renal function, as follows:
- Calculated creatinine clearance < 50 ml/min using the modified Cockroft-Gault equation
- Urinary protein quantitative value of > 30 mg or >1+ on dipstick, unless quantitative protein is < 500 mg in a 24 hour urine sample
- Hepatic function, as follows:
- Aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) (if liver metastases are present, ≥ 5 x ULN)
- Alanine aminotransferase (ALT) > 2.5 x ULN (if liver metastases are present, ≥ 5 x ULN)
- Alkaline phosphatase > 2.0 x ULN (if bone or liver metastases are present, ≥ 5 x ULN)
- Bilirubin > 2.0 x ULN
- Prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 x ULN
- Treatment with anti-cancer therapy (6 weeks for nitrosoureas and mitomycin C chemotherapies), antibody therapy, retinoid therapy, or hormonal therapy within 4 weeks before study day 1. Prior and concurrent use of hormone replacement therapy or the use of gonadotropin-releasing hormone (GnRH) modulators for prostate cancer are permitted
- Therapeutic or palliative radiation therapy within 4 weeks before enrollment (subjects must have resolution of any significant adverse effects from radiation therapy received prior to 2 weeks before enrollment)
- Concurrent or prior (within 1 week of study Day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) for prophylaxis against central venous catheter thrombosis
- Prior participation in clinical drug trials within 4 weeks before enrollment
- For subjects receiving erlotinib, the use of ketoconazole, clarithromycin, voriconazole, troleandomycin, telithromycin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort is prohibited
- For subjects receiving sorafenib, use of St. John's Wort, rifampin, phenytoin, carbamazepine, dexamethasone, and phenobarbital (CYP3A inducers) is prohibited
- Type 1 or 2 diabetics are excluded
About this study
Official title: A Phase 1b Study of AMG 479 With Biologics or Chemotherapy in Adult Subjects With Advanced Solid Tumors
To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib, or gemcitabine in subjects with advanced solid tumors. Up to 126 subjects may be enrolled. Sorafenib and erlotinib combo cohorts are enrolling. All other combo cohorts are closed to enrollment.
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Solid Tumors, Tumors
- Being tested
- AMG 479
- Keywords
- Advanced Solid Tumors, AMG 479, Amgen, Oncology, Phase 1b
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 479Drug
AMG 479 is a fully human IgG1 monoclonal antibody that inhibits IGF-1R signalling. AMG 479 (6mg/kg or 12mg/kg) will be given IV every 2 weeks in combination with sorafenib (400 mg po BID) or erlotinib (150 mg po QD).
| Study group | Role | What they receive |
|---|---|---|
| AMG 479 + Sorafenib cohorts | Experimental | The aim is to determine the safety, tolerability and PK of AMG 479 with sorafenib. AMG 479 will be given bi-weekly; sorafenib will be given daily. Receives: Drug: AMG 479 |
| AMG 479 + Erlotinib cohorts | Experimental | The aim is to determine the safety, tolerability and PK of AMG 479 with erlotinib. AMG 479 will be given bi-weekly; erlotinib will be given daily. Receives: Drug: AMG 479 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib or gemcitabine in subjects with advanced solid tumors
Measured: 3 years
Secondary outcomes (4)
To evaluate pharmacokinetic (PK) profiles of biologics or chemotherapy when used in combination with AMG 479
Measured: 3 years
To evaluate tumor response as assessed by World Health Organization (WHO) criteria
Measured: 3 years
To evaluate tumor response as measured by volumetric computed tomography (CT)
Measured: 3 years
To evaluate anti-AMG 479 antibody response following AMG 479 administration
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startDec 2006
- Primary completionSep 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignancyStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974896
- Sponsor's protocol ID
- 20060134
- Other IDs
- QUILT-2.016
- Status last verified
- Oct 2016
- First submitted
- 10 Sep 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of AMG 479 With Biologics or Chemotherapy in Adult Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00974896
- Acronym / sponsor ID
- 20060134
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Solid Tumors, Tumors
- Keywords
- Advanced Solid Tumors, AMG 479, Amgen, Oncology, Phase 1b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NantCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib, or gemcitabine in subjects with advanced solid tumors. Up to 126 subjects may be enrolled. Sorafenib and erlotinib combo cohorts are enrolling. All other combo cohorts are closed to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 479 + Sorafenib cohorts | Experimental | Drug: AMG 479The aim is to determine the safety, tolerability and PK of AMG 479 with sorafenib. AMG 479 will be given bi-weekly; sorafenib will be given daily. |
| AMG 479 + Erlotinib cohorts | Experimental | Drug: AMG 479The aim is to determine the safety, tolerability and PK of AMG 479 with erlotinib. AMG 479 will be given bi-weekly; erlotinib will be given daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
- Men and women ≥ 18 years old with a pathologically or cytologically documented, advanced solid tumor that is refractory to at least one line of therapy or for whom no standard therapy is available and for which no curative therapy is available, or the subject refuses standard non-curative therapy
- Measurable disease or evaluable disease per World Health Organization (WHO) guidelines
- Eastern Cooperative Oncology Group performance status ≤ 2
- Life expectancy of 3 months as documented by the investigator
Key exclusion criteria (35 listed)
- Any co-morbid medical condition that would increase the risk of toxicity in the opinion of Investigator or Sponsor
- Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia
- Subjects with primary or metastatic central nervous system (CNS) tumors are not allowed to enroll in the sorafenib cohorts. These subjects are allowed to enroll in the remaining cohorts, only if their CNS tumors have been controlled by prior surgery or radiation, and they have been neurologically stable
- History of lymphoma, leukemia, or high-dose chemotherapy with hematopoietic stem cell rescue
- Uncontrolled hypertension [diastolic >100 mmHg or systolic >150 mmHg]; Subjects enrolling in the sorafenib groups must not have diastolic > 85 mmHg nor systolic > 145 mmHg
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 |
|---|---|---|
| AMG 479AMG 479 is a fully human IgG1 monoclonal antibody that inhibits IGF-1R signalling. AMG 479 (6mg/kg or 12mg/kg) will be given IV every 2 weeks in combination with sorafenib (400 mg po BID) or erlotinib (150 mg po QD). | Drug | AMG 479 + Erlotinib cohorts, AMG 479 + Sorafenib cohorts |
Primary outcome
To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib or gemcitabine in subjects with advanced solid tumors
Time frame: 3 years
4 secondary outcomes
To evaluate pharmacokinetic (PK) profiles of biologics or chemotherapy when used in combination with AMG 479
Time frame: 3 years
To evaluate tumor response as assessed by World Health Organization (WHO) criteria
Time frame: 3 years
To evaluate tumor response as measured by volumetric computed tomography (CT)
Time frame: 3 years
To evaluate anti-AMG 479 antibody response following AMG 479 administration
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 479 in people with Advanced Malignancy and Advanced Solid Tumors, run by NantCell, Inc..
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 35 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib or gemcitabine in subjects with advanced solid tumors (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2016.