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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777699
• Other study ID #: TED11442
• Secondary ID: 2008-003219-11XL
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2008
• Last updated: February 2, 2012
• Start date: August 2008
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• XL765 (SAR245409)
Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing
• erlotinib
Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing

Locations

Country	Name	City	State
United States	Investigational Site Number 168983	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib		Assessed during periodic visits	Yes
Secondary	To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination		Assessed during periodic visits	No
Secondary	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	No