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Completed

NCT Number: NCT00777699

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

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.

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Key information

Conditions

Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 168983

Philadelphia, Pennsylvania, 19111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XL765 (SAR245409)

Drug

Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing

Erlotinib

Drug

Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing

Other names: Tarceva®

Primary outcomes

  1. Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib

    Time frame: Assessed during periodic visits

Secondary outcomes

  1. To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination

    Time frame: Assessed during periodic visits

  2. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 22, 2008
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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