NCT00499239

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2007

Typical duration for phase_1

Geographic Reach
3 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 4, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

July 9, 2007

Last Update Submit

January 3, 2014

Conditions

Non-Hodgkin's LymphomaChronic Lymphocytic LeukemiaMultiple Myeloma

Keywords

Hematologic MalignanciesCLLNHLChronic Lymphocytic LeukemiaNon-Hodgkin's LymphomaCLL and NHLMultiple MyelomaMM

Outcome Measures

Primary Outcomes (1)

  • Determination of MTD

    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 Outcomes (3)

  • Pharmacokinetics of GS-9219 and its metabolites

    AAA) CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6

  • Response rate

    CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6

  • Duration of response

    CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6

Study Arms (1)

GS-9219

EXPERIMENTAL

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

Interventions

GS-9219DRUG

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.

GS-9219

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

UCSF

San Francisco, California, 94143, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77303, United States

Location

Fakultni nemocnice Brno - Bohunice

Brno, 625 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 10 100 34, Czechia

Location

Vseobecna fakultni nemocnice

Prague, 2 128 08, Czechia

Location

State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences

Kaluga Region, 249036, Russia

Location

State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia

Moscow, 105229, Russia

Location

State Institution Hematological Research Center under the Russian Academy of Medical Sciences

Moscow, 125167, Russia

Location

Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin

Moscow, 125284, Russia

Location

Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways"

Moscow, 129128, Russia

Location

State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care

Saint Petersburg, 191024, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development

Saint Petersburg, 197022, Russia

Location

Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care

Saint Petersburg, 197758, Russia

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellMultiple MyelomaHematologic Neoplasms

Interventions

rabacfosadine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeoplasms by Site

Study Officials

  • Michael Hawkins, MD

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 11, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

February 4, 2014

Record last verified: 2014-01

Locations

US(5)RU(10)CZ(5)