A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00862524 |
Recruitment Status :
Completed
First Posted : March 17, 2009
Last Update Posted : October 4, 2012
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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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer Pancreatic Cancer | Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Gemcitabine, nucleoside analogue; intravenous | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: ARRY-334543 + gemcitabine |
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating Drug: Gemcitabine, nucleoside analogue; intravenous multiple dose, single schedule |
- Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. [ Time Frame: Part 1 ]
- Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1 ]
- Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. [ Time Frame: Part 1 ]
- Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks. [ Time Frame: Part 2 ]
- Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response. [ Time Frame: Part 1 ]
- Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 2 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862524
United States, Arizona | |
Pinnacle Oncology/Hematology | |
Phoenix, Arizona, United States, 85258 | |
United States, California | |
Premiere Oncology | |
Santa Monica, California, United States, 90404-2111 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Aurora, Colorado, United States, 80045 | |
United States, Massachusetts | |
Partners, Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Partners, Dana Farber | |
Boston, Massachusetts, United States, 02115 | |
United States, Tennessee | |
Sarah Cannon Research Center | |
Nashville, Tennessee, United States, 37203 |
Responsible Party: | Array BioPharma |
ClinicalTrials.gov Identifier: | NCT00862524 |
Other Study ID Numbers: |
ARRAY-543-206 |
First Posted: | March 17, 2009 Key Record Dates |
Last Update Posted: | October 4, 2012 |
Last Verified: | September 2012 |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |