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

January 3, 2014 updated by: Gilead Sciences

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Fakultni nemocnice Brno - Bohunice
      • Hradec Kralove, Czech Republic, 500
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czech Republic, 775 20
        • Fakultni nemocnice Olomouc
      • Praha, Czech Republic, 10 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha, Czech Republic, 2 128 08
        • Vseobecna Fakultní Nemocnice
  • Russian Federation
      • Kaluga Region, Russian Federation, 249036
        • State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences
      • Moscow, Russian Federation, 105229
        • State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia
      • Moscow, Russian Federation, 125167
        • State Institution Hematological Research Center under the Russian Academy of Medical Sciences
      • Moscow, Russian Federation, 125284
        • Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin
      • Moscow, Russian Federation, 129128
        • Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways"
      • Novosibirsk, Russian Federation, 630087
        • State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital
      • St Petersburg, Russian Federation, 191024
        • Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care
      • 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, 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, 197758
        • Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care
  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • Texas
      • Houston, Texas, United States, 77303
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of MTD
Time Frame: All visits
Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE). The MTD will be the highest dose level immediately below the dose level where two or more of three to six patients experience a dose-limiting toxicity (DLT).
All visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of GS-9219 and its metabolites
Time Frame: AAA) CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Pharmacokinetics (Cmax, Tmax, Clast, Tlast, λz, t1/2, AUClast, AUCinf, and %AUCexp) measured by blood sampling
AAA) CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Response rate
Time Frame: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6

Response rate measured by:

  • CLL: National Cancer Institute Working Group (NCIWG) criteria
  • NHL - National Cancer Institute (NCI) criteria; Response Evaluation in
  • MM - International Myeloma Working Group (IMWG) criteria.
CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Duration of response
Time Frame: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6

Duration of response measured by:

  • CLL: National Cancer Institute Working Group (NCIWG) criteria
  • NHL - National Cancer Institute (NCI) criteria; Response Evaluation in
  • MM - International Myeloma Working Group (IMWG) criteria.
CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Michael Hawkins, MD, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-193-0101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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