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Unacceptable safety profile
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Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts.
Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.
The primary objective of this study is as follows:
To assess the safety, toxicity, and maximum tolerated dose (MTD) of GS 9219 administered via IV administration once every three weeks (21 days) for six treatment cycles, i.e. for a total of 18 weeks, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM).
The secondary objectives of this study are as follows:
To determine the pharmacokinetic parameters of GS 9219 for this regimen and patient population.
To assess the antitumor activity of GS 9219 based on Response Rate and Duration of Response. Progression-free Survival and Overall Survival will be assessed if applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-9219 | Experimental | Escalating doses of GS-9219 (5, 8, 11.5, 16, 22.5, 31.5, 44, and 61.5 mg/m^2) until determination of the maximum tolerated dose (MTD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9219 | Drug | GS-9219 Injection is a clear, and colorless to slightly yellow aqueous solution containing 4 mg/mL of GS 9219. GS 9219 will be administered via IV infusion over 30 minutes in 100 mL of normal saline solution, every 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of MTD | Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE). The MTD will be the highest dose level immediately below the dose level where two or more of three to six patients experience a dose-limiting toxicity (DLT). | All visits |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of GS-9219 and its metabolites | Pharmacokinetics (Cmax, Tmax, Clast, Tlast, λz, t1/2, AUClast, AUCinf, and %AUCexp) measured by blood sampling | AAA) CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6 |
| Response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Hawkins, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | United States | ||
| Northwestern University |
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Response rate measured by:
| CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6 |
| Duration of response | Duration of response measured by:
| CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77303 | United States |
| Fakultni nemocnice Brno - Bohunice | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 10 100 34 | Czechia |
| Vseobecna fakultni nemocnice | Prague | 2 128 08 | Czechia |
| State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences | Kaluga Region | 249036 | Russia |
| State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia | Moscow | 105229 | Russia |
| State Institution Hematological Research Center under the Russian Academy of Medical Sciences | Moscow | 125167 | Russia |
| Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin | Moscow | 125284 | Russia |
| Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways" | Moscow | 129128 | Russia |
| State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care | Saint Petersburg | 191024 | Russia |
| State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, Institute of Hematology and Transplantology n.a. R.M. Gorbacheva | Saint Petersburg | 197022 | Russia |
| State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development | Saint Petersburg | 197022 | Russia |
| Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care | Saint Petersburg | 197758 | Russia |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C531423 | rabacfosadine |
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