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

May 16, 2016 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center
      • Amsterdam, Netherlands, 1081 HV
        • VU Medical Center (VUmc)
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Hospital
      • Rotterdam, Netherlands, 3075 EA
        • Erasmus MC - Daniel den Hoed Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: GS-9820
GS-9820 tablets containing 200 mg of GS-9820 administered orally
Other Names:
  • CAL-120

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: Up to 4 weeks
MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall safety
Time Frame: Up to 5 years
Overall safety will be assessed by overall safety profile, enumeration and description of any dose-limiting toxicities, serious adverse events, or adverse events leading to discontinuation of study drug.
Up to 5 years
Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC
Time Frame: Baseline to Day 29
  • Cmax is defined as the maximum concentration of drug
  • Tmax is defined as the time of Cmax
  • Ctrough is defined as the trough concentration
  • AUC is defined as the area under the plasma concentration versus time curve
Baseline to Day 29
Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines
Time Frame: Baseline to Day 29
Baseline to Day 29
Tumor control
Time Frame: Up to 5 years
Tumor control as assessed by overall response rate (ORR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), percent change in lymph node area, lymph node response rate, splenomegaly response rate, ALC response rate, hepatomegaly response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate.
Up to 5 years
Patient well-being assessed using changes in baseline in HRQL (health related quality of life questionnaire) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym)
Time Frame: Up to 5 years
Up to 5 years
Drug exposure
Time Frame: Up to 5 years
Drug administration for GS-9820 as assessed by prescribing records and GS-9820 compliance as assessed by quantification of used and unused drug.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-315-0102
  • 2012-000360-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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