A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Lymphoid Malignancies

Treatments: Drug: GS-9820

Study type: Interventional

Funder types: Industry

Identifiers

NCT01705847

2012-000360-19 (EudraCT Number)

GS-US-315-0102

Details and patient eligibility

About

This study is to determine the appropriate dosing regimen of GS-9820 in subjects with lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL
• Measurable lymphadenopathy
• Requires therapy

Exclusion criteria

• Recent history of a major non-lymphoid malignancy
• Evidence of ongoing infection
• Concurrent participation in another therapeutic clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

GS-9820

Experimental group

Description:

Participants will be sequentially enrolled at progressively higher dose levels to receive GS-9820 administered twice a day. Escalation will proceed to the maximum tolerated dose (MTD), defined as the highest tested dose associated with a rate of dose-limiting toxicities (DLT) of \< 33% during the first 4 weeks of therapy.

Treatment:

Drug: GS-9820