Multi-Center, Open-Label Phase 1B Study to Evaluate the Safety and Tolerability of HGS1036 in Combination With Paclitaxel and Carboplatin, Cisplatin and Etoposide, or Docetaxel in Subjects With Advanced Solid Malignancies
This study will consist of 3 regimens each containing 2 dose levels of HGS1036 and full dose
chemotherapy. Patients will be treated in sequence with HGS1036 at planned dose levels of 10
mg/kg and 20 mg/kg. Patients who demonstrate stable disease or better may continue to
receive HGS1036 until progressive disease, unacceptable toxicity, patient requests
discontinuation of study treatment, or the Investigator feels further treatment is not in
the patient's best interest. After discontinuation of HGS1036, subjects will be followed for
30 days after the last dose of HGS1036 for safety. The end of study will be defined as 1
year after the last subject begins treatment of HGS1036. Any subject still receiving HGS1036
at this pre-defined end of study, may continue to receive HGS1036, but the only study
assessments required will be for safety.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Up to 1 year or longer if indicated.
Yes
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
HGS1036-C1118
NCT01604863
June 2012
July 2014
Name | Location |
---|---|
Phoenix, Arizona 85012 | |
Boston, Massachusetts |