Status:
TERMINATED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Follicular Lymphoma
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 lymphocy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02258555
Start Date
January 1 2015
End Date
August 1 2015
Last Update
October 19 2015
Active Locations (6)
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1
City of Hope
Duarte, California, United States, 91010
2
Cancer Care Center of Fresno
Fresno, California, United States, 93720
3
Innovative Clinical Research Institute
Whittier, California, United States, 90603
4
Cancer Center Central Connecticut
Southington, Connecticut, United States, 06489