drugset / Trial / NCT02392611
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives of this study are to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or recommended dose for phase 2 study (RDP2) of alobresib as a monotherapy in participants with advanced solid tumors and lymphomas, and in combination with exemestane or fulvestrant in participants with advanced estrogen receptor positive breast cancer.
Timeline
- Start
- 2015-03-16
- Primary completion
- 2017-10-11
- Completion
- 2017-10-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alobresib | Small molecule | 0.6 mg | Oral |
| Subject | Alobresib | Small molecule | 1.4 mg | Oral |
| Subject | Alobresib | Small molecule | 2 mg | Oral |
| Subject | Alobresib | Small molecule | 3 mg | Oral |
| Subject | Alobresib | Small molecule | 4 mg | Oral |
| Subject | Alobresib | Small molecule | 6 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |
| Background | Fulvestrant | Small molecule | 500 mg | Intramuscular |