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

NCT ID: NCT01705847

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoid Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GS-9820

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.

Group Type EXPERIMENTAL

GS-9820

Intervention Type DRUG

GS-9820 tablets containing 200 mg of GS-9820 administered orally

Interventions

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GS-9820

GS-9820 tablets containing 200 mg of GS-9820 administered orally

Intervention Type DRUG

Other Intervention Names

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CAL-120

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry Adewoye, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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VU Medical Center (VUmc)

Amsterdam, , Netherlands

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status

Erasmus MC - Daniel den Hoed Cancer Center

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2012-000360-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-315-0102

Identifier Type: -

Identifier Source: org_study_id

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