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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00862524
Other study ID # ARRAY-543-206
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 16, 2009
Last updated September 28, 2012
Start date March 2009
Est. completion date February 2011

Study information

Verified date September 2012
Source Array BioPharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine.

The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Key Inclusion Criteria (Part 1):

- Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine.

- No more than 3 prior anticancer regimens for advanced disease.

- Measurable or evaluable, nonmeasurable disease.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

- Able to take and retain oral medications.

- Additional criteria exist.

Key Exclusion Criteria (Part 1):

- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).

- Treatment with prior chemotherapy within 21 days of first dose of study drug.

- Requiring IV alimentation.

- Pregnancy or lactation.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.

- History of being unable to tolerate gemcitabine or any of its components.

- Additional criteria exist.

Study Design

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


Intervention

Drug:
ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
Gemcitabine, nucleoside analogue; intravenous
multiple dose, single schedule

Locations

Country Name City State
United States University of Colorado Health Sciences Center Aurora Colorado
United States Partners, Dana Farber Boston Massachusetts
United States Partners, Massachusetts General Hospital Boston Massachusetts
United States Sarah Cannon Research Center Nashville Tennessee
United States Pinnacle Oncology/Hematology Phoenix Arizona
United States Premiere Oncology Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Array BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. Part 1 Yes
Primary Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. Part 1 Yes
Primary Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. Part 1 No
Primary Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks. Part 2 No
Secondary Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response. Part 1 No
Secondary Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. Part 2 Yes
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