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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00710736 |
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Date of registration:
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02/07/2008 |
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Primary sponsor: |
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Public title:
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A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer
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Scientific title:
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Date of first enrolment:
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June 2008 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00710736 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Cancer
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Intervention(s)
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Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
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Drug: Capecitabine, 5-fluorouracil prodrug; oral
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Primary Outcome(s)
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Characterize the pharmacokinetics (PK) of study drug and capecitabine.
[Time Frame: Duration of study]
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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]
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Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine.
[Time Frame: Duration of study]
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Secondary Outcome(s)
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Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine.
[Time Frame: Duration of study]
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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]
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Secondary ID(s)
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ARRAY-543-204
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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