Safety Study of XL765 (SAR245409) in Combination With Erl... | NCT00777699

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

NCT00777699

Sponsor

Sanofi

Status

Completed

Last Update Posted

Feb 3, 2012Estimated

Enrollment

80Actual

Phase

Phase 1

Conditions

Cancer
Non-Small Cell Lung Cancer

Interventions

XL765 (SAR245409)
erlotinib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-003219-11	EudraCT Number
XL765-003	Other Identifier	(other study code)

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Oct 20, 2008

First Submission Date that Met QC Criteria

Oct 20, 2008

First Posted Date

Oct 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2012

Last Update Posted Date

Feb 3, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: XL765 (SAR245409) Drug: erlotinib

Name	Type	Description	Arm Group Labels	Other Names
XL765 (SAR245409)	Drug	Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib		Assessed during periodic visits

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009369	Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
C576808	XL765
D000069347	Erlotinib Hydrochloride

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds