Clinical trial NCT00499239: A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Multiple Myeloma
Keywords: Hematologic Malignancies
CLL
NHL
Chronic Lymphocytic Leukemia
Non-Hodgkin's Lymphoma
CLL and NHL
Multiple Myeloma
MM
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Determination of MTD
timeFrame: All visits
Secondary outcomes:
measure: Pharmacokinetics of GS-9219 and its metabolites
timeFrame: AAA) CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
measure: Response rate
timeFrame: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
measure: Duration of response
timeFrame: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno - Bohunice
city: Hradec Kralove
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czech Republic
facility: Fakultni nemocnice Olomouc
city: Praha
country: Czech Republic
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha
country: Czech Republic
facility: Vseobecna fakultni nemocnice
city: Kaluga Region
country: Russian Federation
facility: State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia
city: Moscow
country: Russian Federation
facility: State Institution Hematological Research Center under the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin
city: Moscow
country: Russian Federation
facility: Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways"
city: Novosibirsk
country: Russian Federation
facility: State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital
city: St Petersburg
country: Russian Federation
facility: Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care
city: St. Petersburg
country: Russian Federation
facility: 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
city: St. Petersburg
country: Russian Federation
facility: State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development
city: St. Petersburg
country: Russian Federation
facility: Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care
Study officials:
affiliation: Gilead Sciences
name: Michael Hawkins, MD
role: STUDY_DIRECTOR
References: