Status:
COMPLETED
A Phase 1 Study of AMG 208 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Amgen
Conditions:
Cancer
Oncology
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
First in human, open-label, sequential dose escalation and expansion study of AMG 208 in subjects with advanced solid tumors.
Eligibility Criteria
Inclusion
- Men or women ≥ 18 years old
- Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
- Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for Part 1 of the study)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Life expectancy of \> 3 months, in the opinion of the investigator
- Female subjects who are post-menopausal (no menstrual period for a minimum of 12 months), or surgically sterilized. Female subjects of child bearing potential must remain abstinent or use double-barrier birth control method during the period of therapy and must be willing to use contraception 2 weeks following the last study drug administration and have a negative serum pregnancy test upon entry into this study
- Male subject is willing to use contraception upon enrollment, during the course of the study and for 12 weeks following the last study drug administration
- Willing to provide tumor samples and / or slides
- Competent to sign and date an Institutional Review Board approved informed consent form
- Hematological function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin \> 9 g/dL Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 x institutional upper limit of normal (IULN)
- Renal function, as follows:
- Serum creatinine \< 2.0 mg/dL
- Hepatic function, as follows:
- AST/ALT \< 3x ULN and total bilirubin \< 1.5x ULN in all subjects Alkaline phosphatase \< 2.0 x ULN (if liver or bone metastases are present, ≤ 5 x ULN)
Exclusion
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.
- Primary central nervous system (CNS) tumors or metastases
- History of bleeding diathesis
- Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension in the opinion of the investigator
- A baseline ECG QTc \> 480 ms
- Active infection within 2 weeks of study enrollment (day 1)
- Significant gastrointestinal disorder(s), in the opinion of the investigator, (e.g. Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that may influence drug absorption
- Known positive test for HIV
- Known acute or chronic hepatitis B or hepatitis C infection, determined by serologic tests
- Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy, or investigational agent) within 28 days of study day 1 (six weeks for nitrosureas, mitomycin C, or antibody or molecular targeted agents with t1/2 \> 10 days); concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer or breast cancer is permitted
- Treatment with immune modulators including, but not limited to, systemic corticosteroids, cyclosporine and tacrolimus within two weeks prior to enrollment
- Therapeutic or palliative radiation therapy within 2 weeks of study day 1
- Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low-dose warfarin \[≤ 2 mg/day\] or low molecular weight heparins for prophylaxis against central venous catheter thrombosis or aspirin \[81 mg/day\] is allowed)
- Prior participation in an investigational study and/or procedure within 28 days of study day 1
- Major surgery within 30 days of study day 1
- Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00813384
Start Date
December 1 2008
End Date
December 1 2014
Last Update
December 16 2014
Active Locations (3)
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1
Research Site
Beverly Hills, California, United States, 90211
2
Research Site
St Louis, Missouri, United States, 63110
3
Research Site
Houston, Texas, United States, 77030