Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00777699
First received: October 20, 2008
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Non-Small Cell Lung Cancer |
Drug: XL765 (SAR245409) Drug: erlotinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: XL765 (SAR245409)
Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing
Drug: erlotinib
Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing
Other Name: Tarceva®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777699
Locations
| United States, Pennsylvania | |
| Investigational Site Number 168983 | |
| Philadelphia, Pennsylvania, United States, 19111 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00777699 History of Changes |
| Other Study ID Numbers: | TED11442, 2008-003219-11, XL765-003 |
| Study First Received: | October 20, 2008 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration Spain: Spanish Agency of Medicines |
Keywords provided by Sanofi:
|
Cancer Solid Tumors NSCLC |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013