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

NCT ID: NCT02258555

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

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.

Conditions

Follicular Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GS-9901

Participants will receive one of 6 escalating doses of GS-9901 once daily until unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anti-cancer or experimental therapy, or other protocol-specified reasons for GS-9901 discontinuation.

Group Type: EXPERIMENTAL

GS-9901

Intervention Type: DRUG

GS-9901 tablets administered orally

Interventions

GS-9901

GS-9901 tablets administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of FL, MZL, SLL, or CLL (meeting International Workshop on CLL [IWCLL] Criteria, 2008) as documented by medical records and with histology based on criteria established by the World Health Organization

• FL Grades 1, 2, or 3a
• SLL with absolute lymphocyte count of < 5 x 10^9/L at initial diagnosis
• MZL (splenic, nodal, or extra-nodal)
• Prior treatment for FL or CLL/SLL with ≥ 1 prior chemotherapy-based or immunotherapy-based regimen with no approved therapies available
• Presence of radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy
• All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted], or bone marrow parameters [any of Grade 1, 2, or 3 permitted)
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Able to provide written informed consent

Exclusion Criteria

• History of lymphoid malignancy other than FL, MZL, SLL, or CLL
• History of myelodysplastic syndrome
• History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to start of study therapy, or any other cancer that has been in complete remission for ≥ 5 years
• Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy
• Ongoing drug-induced pneumonitis
• Ongoing inflammatory bowel disease
• History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
• History of prior therapy with any inhibitor of serine/threonine kinase (AKT), Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3-kinase (PI3K), or spleen tyrosine kinase (SYK)
• Ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Adewoye, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

City of Hope

Duarte, California, United States

Cancer Care Center of Fresno

Fresno, California, United States

Innovative Clinical Research Institute

Whittier, California, United States

Cancer Center Central Connecticut

Southington, Connecticut, United States

Lombardi Cancer Center-Georgetown University

Washington D.C., District of Columbia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Countries

United States

Other Identifiers

2014-005441-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-325-1348

Identifier Type: -

Identifier Source: org_study_id