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

Gilead Sciences

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Multiple Myeloma; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: GS-9219

Study type: Interventional

Funder types: Industry

Identifiers

NCT00499239

GS-US-193-0101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

GS-9219

Experimental group

Description:

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)

Treatment:

Drug: GS-9219