Skip to main content
OpenTrials
Completed

NCT Number: NCT01705847

A Phase 1b Study Evaluating 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoid Malignancies Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Academic Medical Center, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-9820

Drug

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

Other names: CAL-120

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2012
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.