First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Neoplasms
In brief
Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024.
Key facts
- Study ID
- NCT01323933
- Run by
- Gilead Sciences
- People needed
- 32
- Starts
- 2010-06-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2012-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available
- Measurable or evaluable disease
- ECOG Performance Status of ≤2
- No known active central nervous system (CNS) tumors or CNS metastases
- Adequate organ function
You may not qualify if…
- Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- History of surgery within 28 days prior to enrollment or anticipated surgery during the study period
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 28 days of study Day 1 (six weeks for nitrosoureas, mitomycin C, antibodies, or molecular agents with t½ >10 days); (concurrent use of hormone therapy for breast or prostate cancer is permitted)
- Treatment with immune modulators including, but not limited to, cyclosporine and tacrolimus within two weeks prior to enrollment
- Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy; (low-dose warfarin [<2 mg/day] for prophylaxis against central venous catheter thrombosis is allowed)
- Patient with tumor that is infiltrating or invading a major blood vessel
Where it is running
- Karmanos Cancer Institute — Detroit, Michigan, United States
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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