A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)
| Tracking Information | |||||
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| First Received Date ICMJE | July 9, 2007 | ||||
| Last Updated Date | December 10, 2010 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety- Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE); Maximum Tolerated Dose (MTD) | ||||
| Change History | Complete list of historical versions of study NCT00499239 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
Efficacy: CLL- accessed according to the NCI Working Group Response Criteria; NHL will be assessed according to the NCI Response Criteria for NHL; Pharmacokinetics of GS-9219 | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 62 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Czech Republic, Russian Federation | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00499239 | ||||
| Other Study ID Numbers ICMJE | GS-US-193-0101 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Michael Hawkins, Senior Director, Clinical Research, Gilead Sciences | ||||
| Study Sponsor ICMJE | Gilead Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Gilead Sciences | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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