A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Multiple Myeloma |
Drug: GS-9219 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-center, Open-label, Dose-escalating Phase I/II Trial of GS-9219 Administered Once Every Three Weeks Intravenously to Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma or Multiple Myeloma |
- Safety- Toxicity will be graded according to the NCI CTCAE. The MTD will be the highest dose level immediately below the dose level where two or more of three to six patients experienced DLT. [ Time Frame: All visits ] [ Designated as safety issue: Yes ]
- Response Evaluation in CLL - NCIWG criteria; in NHL - NCI criteria; Response Evaluation in MM - Int'l Myeloma Working Group criteria. Response Rate, Duration of Response. PK:GS 9219 and its metabolites. [ Time Frame: 1, 3, 6 cycles: CLL/NHL; Each cycle: MM ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 62 |
| Study Start Date: | July 2007 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
-
Drug: GS-9219
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, q 21 days.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Relapsed or refractory CLL, NHL or MM
- ECOG Performance Status of 0, 1, or 2
- Adequate organ function (protocol defined)
- ECG without evidence of clinically significant ventricular arrhythmias
Exclusion Criteria:
- AIDS-related lymphoma
- Subjects with NHL who present exclusively with non-measurable lesions
- Subjects with MM who have non-secretory and/or non-measurable disease
- Recent anticancer therapy (chemotherapy, radiotherapy, and/or biotherapy)within four weeks prior to starting treatment
- Evidence of pulmonary fibrosis
- Other concurrent malignancy
- Uncontrolled concurrent illness
- Receiving chronic, systemically administered steroids
- Known hypersensitivity to nucleoside analogues
Contacts and Locations| United States, California | |
| UCSF | |
| San Francisco, California, United States, 94143 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77303 | |
| Czech Republic | |
| Fakultni nemocnice Brno - Bohunice | |
| Brno, Czech Republic, 625 00 | |
| Fakultni nemocnice Hradec Kralove | |
| Hradec Kralove, Czech Republic, 500 | |
| Fakultni nemocnice Olomouc | |
| Olomouc, Czech Republic, 775 20 | |
| Vseobecna fakultni nemocnice | |
| Praha, Czech Republic, 2 128 08 | |
| Fakultni nemocnice Kralovske Vinohrady | |
| Praha, Czech Republic, 10 100 34 | |
| Russian Federation | |
| State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences | |
| Kaluga Region, Russian Federation, 249036 | |
| Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin | |
| Moscow, Russian Federation, 125284 | |
| Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways" | |
| Moscow, Russian Federation, 129128 | |
| State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia | |
| Moscow, Russian Federation, 105229 | |
| State Institution Hematological Research Center under the Russian Academy of Medical Sciences | |
| Moscow, Russian Federation, 125167 | |
| State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital | |
| Novosibirsk, Russian Federation, 630087 | |
| Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care | |
| St Petersburg, Russian Federation, 191024 | |
| 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 | |
| St. Petersburg, Russian Federation, 197022 | |
| State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development | |
| St. Petersburg, Russian Federation, 197022 | |
| Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care | |
| St. Petersburg, Russian Federation, 197758 | |
| Study Director: | Michael Hawkins, MD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Michael Hawkins, Senior Director, Clinical Research, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00499239 History of Changes |
| Other Study ID Numbers: | GS-US-193-0101 |
| Study First Received: | July 9, 2007 |
| Last Updated: | December 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
Hematologic Malignancies CLL NHL Chronic Lymphocytic Leukemia |
Non-Hodgkin's Lymphoma CLL and NHL Multiple Myeloma MM |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 16, 2013