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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: |
NCT00777699 |
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Date of registration:
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20/10/2008 |
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Primary sponsor: |
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Public title:
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Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
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Scientific title:
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A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00777699 |
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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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Spain
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United States
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed diagnosis of:
- Advanced solid tumor that is no longer responding to therapies OR
- Advanced or metastatic NSCLC that has previously been treated with erlotinib or
gefitinib
- ECOG Performance Status 0-1
- Adequate organ and bone arrow function as defined by hematological and serum
chemistry limits
- At least 18 years old
- Both men and women must practice adequate contraception
- Informed consent
Exclusion Criteria:
- Restriction of some therapies/medications within specific timeframes prior to
enrollment and during the study including prior therapy with PI3K, cytotoxic
chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase
inhibitors, non-cytotoxic hormonal agents
- Erlotinib intolerant
- Taking oral corticosteroids chronically or > 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus and an HgbA1c > 7%
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
- Congestive heart failure, unstable angina, or a myocardial infarction within 3 months
of entering the study.
- HIV positive
- Diagnosis of another malignancy may exclude subject from study
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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Cancer
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Non-Small Cell Lung Cancer
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Intervention(s)
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Drug: erlotinib
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Drug: XL765 (SAR245409)
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Primary Outcome(s)
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Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib
[Time Frame: Assessed during periodic visits]
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Secondary Outcome(s)
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To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination
[Time Frame: Assessed during periodic visits]
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To evaluate preliminary efficacy of XL765 in combination with erlotinib in subjects with non-small-cell lung cancer (NSCLC) and other solid tumors
[Time Frame: Assessed during periodic visits]
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Secondary ID(s)
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2008-003219-11
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TED11442
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XL765-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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