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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00499239
• Other study ID #: GS-US-193-0101
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 9, 2007
• Last updated: January 3, 2014
• Start date: July 2007
• Est. completion date: October 2010

Study information

• Verified date: January 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin's Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	Fakultni nemocnice Brno - Bohunice	Brno
Czech Republic	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czech Republic	Fakultni nemocnice Olomouc	Olomouc
Czech Republic	Fakultni nemocnice Kralovske Vinohrady	Praha
Czech Republic	Vseobecna fakultni nemocnice	Praha
Russian Federation	State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences	Kaluga Region
Russian Federation	Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin	Moscow
Russian Federation	Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways"	Moscow
Russian Federation	State Institution Hematological Research Center under the Russian Academy of Medical Sciences	Moscow
Russian Federation	State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia	Moscow
Russian Federation	State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital	Novosibirsk
Russian Federation	Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care	St Petersburg
Russian Federation	Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care	St. Petersburg
Russian Federation	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	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
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Czech Republic,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics of GS-9219 and its metabolites	Pharmacokinetics (Cmax, Tmax, Clast, Tlast, ?z, 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	No
Secondary	Response rate	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	No
Secondary	Duration of response	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	No