Clinical Trial: Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Adults With Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 1b Dose-escalation Study Evaluating the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Subjects With Relapsed or Refractory Follicular Lymphoma, M

Brief Summary: This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). The study will also characterize the pharmacokinetic (PK) profile of GS-9901, determine the appropriate dosing regimen of GS-9901 for use in future clinical trials, and to evaluate the efficacy of GS-9901 monotherapy in adults with FL, MZL, CLL, or SLL.

Detailed Summary:
Sponsor: Gilead Sciences

Current Primary Outcome: Occurrence of adverse events (AEs) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.


Original Primary Outcome: Occurrence of adverse events (AEs) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Current Secondary Outcome:

  • Occurrence of AEs and clinical laboratory abnormalities not defined as DLTs [ Time Frame: Up to 2 years ]
    Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.
  • Overall response rate [ Time Frame: Up to 2 years ]
    Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
  • Progression-free survival [ Time Frame: Up to 2 years ]
    Progression-free survival (PFS) is defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause.
  • Duration of response [ Time Frame: Up to 2 years ]
    Duration of response (DOR) is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.
  • PK profile of GS-9901 [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, and 24 hours postdose on Days 1 and 15; predose and 1.5 hours postdose on Days 29, 43, 85, and 169 ]

    This endpoint will measure the plasma PK profile of GS-9901. The following parameters will be measured:

    • Cmax: maximum observed concentration of drug in plasma
    • AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)


Original Secondary Outcome:

  • Target inhibition [ Time Frame: Up to 2 years ]
    Target inhibition will be assessed by basophil stimulation assay.
  • Occurrence of AEs and clinical laboratory abnormalities not defined as DLTs [ Time Frame: Up to 2 years ]
    Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.
  • Overall response rate [ Time Frame: Up to 2 years ]
    Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
  • Progression-free survival [ Time Frame: Up to 2 years ]
    Progression-free survival (PFS) is defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause.
  • Duration of response [ Time Frame: Up to 2 years ]
    Duration of response (DOR) is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.
  • PK profile of GS-9901 [ Time Frame: Predose and postdose on Days 1 and 15 ]

    This composite endpoint will measure the plasma PK profile of GS-9901. The following parameters will be measured:

    • Cmax: maximum observed concentration of drug in plasma
    • AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)


Information By: Gilead Sciences

Dates:
Date Received: October 3, 2014
Date Started: January 2015
Date Completion:
Last Updated: October 15, 2015
Last Verified: October 2015