A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer

NCT00862524 | Completed Phase 1

• 1 other identifier: ARRAY-543-206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief 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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Conditions

Advanced Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.

  Part 1

• Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.

  Part 1

• Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.

  Part 1

• Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.

  Part 2

Secondary Outcomes (2)

• Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.

  Part 1

• Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.

  Part 2

Study Arms (1)

ARRY-334543 + gemcitabine

EXPERIMENTAL

Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; Drug: Gemcitabine, nucleoside analogue; intravenous

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral DRUG

multiple dose, escalating

ARRY-334543 + gemcitabine

Gemcitabine, nucleoside analogue; intravenous DRUG

multiple dose, single schedule

ARRY-334543 + gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array BioPharma: lead

Study Sites (6)

Pinnacle Oncology/Hematology

Phoenix, Arizona, 85258, United States

Location

Premiere Oncology

Santa Monica, California, 90404-2111, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Partners, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Partners, Dana Farber

Boston, Massachusetts, 02115, United States

Location

Sarah Cannon Research Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

ARRY-334543; Gemcitabine; Nucleosides

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

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

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 4, 2012

Record last verified: 2012-09

Locations

US (6)