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| Sponsored by: |
Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00499239 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 62 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF | Completed |
| San Francisco, California, United States, 94143 | |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Olga Frankfurt, MD 312-695-4441 o-frankfurt@md.northwestern.edu | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Completed |
| Boston, Massachusetts, United States, 02115 | |
| United States, Nevada | |
| Nevada Cancer Institute | Recruiting |
| Las Vegas, Nevada, United States, 89135 | |
| Contact: Nam Dang, MD 702-822-5445 ndang@nvcancer.org | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77303 | |
| Contact: Stefan Faderl, MD 713-745-4613 sfaderl@mdanderson.org | |
| The University of Texas Health Science Center at San Antonio (UTHSCSA), Cancer Therapy & Research Center (CTRC) | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Francis J. Giles, MD 210-450-5882 gilesf@uthscasa.edu | |
| Czech Republic | |
| Vseobecna fakultni nemocnice | Recruiting |
| Praha, Czech Republic, 2 128 08 | |
| Contact: Marek Trneny, MD 420 602 267 253 trneny@cesnet.cz | |
| Fakultni nemocnice Brno - Bohunice | Recruiting |
| Brno, Czech Republic, 625 00 | |
| Contact: Jiri Mayer, MD 420 5 3223 3642 jmayer@fnbrno.cz | |
| Fakultni nemocnice Hradec Kralove | Recruiting |
| Hradec Kralove, Czech Republic, 500 | |
| Contact: David Belada, MD 420 602 128 826 david.belada@seznam.cz | |
| Fakultni nemocnice Olomouc | Recruiting |
| Olomouc, Czech Republic, 775 20 | |
| Contact: Tomas Papajik, MD 420 588 443 200 tomas.papajik@fnol.cz | |
| Fakultni nemocnice Kralovske Vinohrady | Recruiting |
| Praha, Czech Republic, 10 100 34 | |
| Contact: Tomas Kozak, MD 420 267 162 292 kozak@fnkv.cz | |
| Study Director: | Michael Hawkins, MD | Gilead Sciences |
More Information
| Responsible Party: | Gilead Sciences ( Michael Hawkins, Senior Director, Clinical Research ) |
| Study ID Numbers: | GS-US-193-0101 |
| Study First Received: | July 9, 2007 |
| Last Updated: | April 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00499239 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hematologic Malignancies CLL NHL Chronic Lymphocytic Leukemia |
Non-Hodgkin's Lymphoma CLL and NHL Multiple Myeloma MM |
|
Leukemia, Lymphoid Immunoproliferative Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma Lymphoma, Small Cleaved-cell, Diffuse Leukemia |
Lymphatic Diseases Chronic Lymphocytic Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
|
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma Leukemia |
Lymphatic Diseases Neoplasms Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Cardiovascular Diseases Leukemia, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
