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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GS-9219

Escalating doses of GS-9219 (5, 8, 11.5, 16, 22.5, 31.5, 44, and 61.5 mg/m\^2) until determination of the maximum tolerated dose (MTD)

Group Type EXPERIMENTAL

GS-9219

Intervention Type DRUG

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, every 21 days.

Interventions

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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, every 21 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No