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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005441-53 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-9901 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9901 | Drug | GS-9901 tablets administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AEs) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs) | Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of AEs and clinical laboratory abnormalities not defined as DLTs | Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities. | Up to 2 years |
| Overall response rate |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Adewoye, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Cancer Care Center of Fresno |
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Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
| Up to 2 years |
| Progression-free survival | 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. | Up to 2 years |
| Duration of response | 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. | Up to 2 years |
| PK profile of GS-9901 | This endpoint will measure the plasma PK profile of GS-9901. The following parameters will be measured:
| 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 |
| Fresno |
| California |
| 93720 |
| United States |
| Innovative Clinical Research Institute | Whittier | California | 90603 | United States |
| Cancer Center Central Connecticut | Southington | Connecticut | 06489 | United States |
| Lombardi Cancer Center-Georgetown University | Washington D.C. | District of Columbia | 02007 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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