A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
This study has been completed.
Sponsor:
Array BioPharma
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00862524
First received: March 16, 2009
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).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 | Intervention | Phase |
|---|---|---|
|
Advanced Cancer Pancreatic Cancer |
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Gemcitabine, nucleoside analogue; intravenous |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Array BioPharma:
Primary Outcome Measures:
- Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. [ Time Frame: Part 1 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response. [ Time Frame: Part 1 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | March 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ARRY-334543 + gemcitabine |
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
Drug: Gemcitabine, nucleoside analogue; intravenous
multiple dose, single schedule
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862524
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862524
Locations
| 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 | |
Sponsors and Collaborators
Array BioPharma
More Information
| Responsible Party: | Array BioPharma |
| ClinicalTrials.gov Identifier: | NCT00862524 History of Changes |
| Other Study ID Numbers: | ARRAY-543-206 |
| Study First Received: | March 16, 2009 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Neoplasms Digestive System Neoplasms Neoplasms by Site 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 |
ClinicalTrials.gov processed this record on September 23, 2016