Status:
COMPLETED
A Study of AMG 337 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Amgen
Conditions:
Advanced Malignancy
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
First in human, open-label, sequential dose escalation and expansion study of AMG 337 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
- Subjects with primary central nervous system (CNS) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up MRI shows no new lesions appearing
- Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Competent to sign and date an Institutional Review Board approved informed consent form
- Adequate hematologic and renal function as determined by laboratory blood and urine tests
Exclusion
- Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug.
- Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
- 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
- A baseline ECG QTc \> 470 ms
- Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
- Significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption
- Known positive test for HIV
- Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
- Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
- 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 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2016
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01253707
Start Date
December 8 2010
End Date
December 13 2016
Last Update
November 7 2022
Active Locations (8)
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1
Research Site
Los Angeles, California, United States, 90025
2
Research Site
Atlanta, Georgia, United States, 30332
3
Research Site
Chicago, Illinois, United States, 60637
4
Research Site
Boston, Massachusetts, United States, 02114