A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer
This study has been completed.
Sponsor:
Array BioPharma
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00710736
First received: July 2, 2008
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine 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 30 patients from the US and Canada will be enrolled in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Capecitabine, 5-fluorouracil prodrug; oral |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety 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 capecitabine. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Characterize the pharmacokinetics (PK) of study drug and capecitabine. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | June 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ARRY-334543 + capecitabine |
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
Drug: Capecitabine, 5-fluorouracil prodrug; oral
multiple dose, single schedule
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
- Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Must be able to take and retain oral medications.
- Additional criteria exist.
Key Exclusion Criteria:
- Active concomitant malignancies.
- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Requiring intravenous (IV) alimentation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- Pregnancy or lactation.
- Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
- Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
- History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
- Additional criteria exist.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710736
Locations
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency- Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Canada, Ontario | |
| The Ottawa Hospital Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
Sponsors and Collaborators
Array BioPharma
More Information
No publications provided
| Responsible Party: | Array BioPharma |
| ClinicalTrials.gov Identifier: | NCT00710736 History of Changes |
| Other Study ID Numbers: | ARRAY-543-204 |
| Study First Received: | July 2, 2008 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Neoplasms Fluorouracil Capecitabine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013