Completed

A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies

What is being tested

GS-9820

Drug

Who is being recruted

Chronic Disease+17

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: November 2012

See protocol details

Summary

Principal SponsorGilead Sciences

Last updated: May 17, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01705847

Principal SponsorGilead Sciences

Last updated: May 17, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellDisease AttributesHodgkin DiseaseLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-Cell

Criteria

3 inclusion criteria required to participate

Measurable lymphadenopathy

Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL

Requires therapy

3 exclusion criteria prevent from participating

Concurrent participation in another therapeutic clinical trial

Evidence of ongoing infection

Recent history of a major non-lymphoid malignancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

VU Medical Center (VUmc)

Amsterdam, NetherlandsOpen VU Medical Center (VUmc) in Google Maps

Academic Medical Center

Amsterdam, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

Erasmus MC - Daniel den Hoed Cancer Center

Rotterdam, Netherlands

Completed4 Study Centers