A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) - Full Text View

Sponsor:	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:	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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499239

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

Sponsors and Collaborators

Gilead Sciences

Investigators

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 February 09, 2012