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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

All visits

Safety Issue:

Yes

Principal Investigator

Michael Hawkins, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-193-0101

NCT ID:

NCT00499239

Start Date:

July 2007

Completion Date:

October 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • Hematologic Malignancies
  • CLL
  • NHL
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma
  • CLL and NHL
  • Multiple Myeloma
  • MM
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
UCSF San Francisco, California  941430324
Northwestern University Chicago, Illinois  60611
Dana Farber Cancer Institute Boston, Massachusetts  02115
Nevada Cancer Institute Las Vegas, Nevada  89135