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

NCT00777699 | Completed Phase 1

• 3 other identifiers: TED114422008-003219-11XL765-003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Non-Small Cell Lung Cancer

Keywords

Cancer; Solid Tumors; NSCLC

Outcome Measures

Primary Outcomes (1)

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

  Assessed during periodic visits

Secondary Outcomes (2)

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

  Assessed during periodic visits

• To evaluate preliminary efficacy of XL765 in combination with erlotinib in subjects with non-small-cell lung cancer (NSCLC) and other solid tumors

  Assessed during periodic visits

Study Arms (1)

1

EXPERIMENTAL

Drug: XL765 (SAR245409); Drug: erlotinib

Interventions

XL765 (SAR245409) DRUG

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

1

erlotinib DRUG

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

Also known as: Tarceva®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 168983

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

XL765; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 22, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

US (1)