CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
Alobresib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02392611
NCT02392611Phase 1Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Mar 19, 2015·Updated Dec 29, 2020

In Brief

A Phase 1 clinical trial evaluating Alobresib, Exemestane, and 1 other intervention for Solid Tumors and Lymphomas. Completed, enrolled 33 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors and Lymphomas
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 19, 2015
Enrollment StartMar 16, 2015
Primary CompletionOct 11, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.3 years ago

Interventions

Alobresibdrug

Tablet administered orally once daily on Study Day 1 through Cycle 1 Day 28 of 28 days cycle

Exemestanedrug

Tablets administered orally once daily on Cycle 1 Day 1 of 28 days cycle

Fulvestrantdrug

Administered intramuscularly on Cycle 1 Day 1 of 28 days cycle and every 28 days