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Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00777699
First received: October 20, 2008
Last updated: February 2, 2012
Last verified: February 2012
  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
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: 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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014