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

Phase 1

Completed

• Conditions: Lymphoid Malignancies
• Interventions: Drug: GS-9820

• Registration Number: NCT01705847
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Study Start: 2012-11
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GS-9820	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.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC	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
Overall safety	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.
Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines	Baseline to Day 29
Tumor control	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.
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)	Up to 5 years
Drug exposure	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.

Trial Locations

Locations (4)

VU Medical Center (VUmc); 🇳🇱 Amsterdam, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Erasmus MC - Daniel den Hoed Cancer Center; 🇳🇱 Rotterdam, Netherlands