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

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) as a Monotherapy in Subjects With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Subjects With Estrogen Receptor Positive Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors and Lymphomas

Interventions

Type	Name	Description
DRUG	Alobresib	Tablet administered orally once daily on Study Day 1 through Cycle 1 Day 28 of 28 days cycle
DRUG	Exemestane	Tablets administered orally once daily on Cycle 1 Day 1 of 28 days cycle
DRUG	Fulvestrant	Administered intramuscularly on Cycle 1 Day 1 of 28 days cycle and every 28 days

Timeline

• Start date: 2015-03-16
• Primary completion: 2017-10-11
• Completion: 2017-10-11
• First posted: 2015-03-19
• Last updated: 2020-12-29
• Results posted: 2020-12-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study