AMG 706 and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma

Phase 1

• Conditions: Lung Cancer; Lymphoma; Lymphoproliferative Disorder; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00324597
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

RATIONALE: AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer or by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving AMG 706 together with gemcitabine may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of AMG 706 when given together with gemcitabine in treating patients with advanced solid tumors or lymphoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose and safety of AMG 706 when given in combination with gemcitabine hydrochloride in patients with advanced solid tumors or lymphoma.

Secondary

* Determine the pharmacokinetic profiles of this regimen in these patients.

OUTLINE: This is a multicenter, open-label, dose-escalation study of AMG 706.

Patients receive oral AMG 706 once daily on days 2-56 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1. For all subsequent courses, patients receive oral AMG 706 on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AMG 706 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.

During the first course of study treatment, patients undergo blood collection periodically for pharmacokinetic analysis.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-11
• Status Verified: 2007-04
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0
Maximum tolerated dose as assessed by NCI CTCAE v3.0

Secondary Outcome Measures

Name	Time	Method
Response rate (complete and partial response) as measured by modified RECIST at weeks 12, 24, 36, 48, and 49
Biomarkers as measured by RNA transcript profiling and/or proteomic methods at weeks 1, 2, 4, 9, 13, 21, 29, 37, 45, 49
Pharmacokinetic profiles as measured by blood sampling at weeks 1, 2, 9, 13, 21, 29, 37, 45, and 49
Incidence of adverse events, serious adverse events, and laboratory abnormalities not defined as dose-limiting toxicities as assessed by NCI CTCAE v3.0

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States