Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors

Phase 1

Completed

• Conditions: Cancer; Non-Small Cell Lung Cancer; Endometrial Carcinoma; Ovarian Carcinoma
• Interventions: Drug: XL147 (SAR245408),; Drug: paclitaxel; Drug: carboplatin

• Registration Number: NCT00756847
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells. In clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-22
• Primary Completion: 2012-05
• Study Completion: 2012-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Confirmed diagnosis of:

  • Advanced solid tumor that is no longer responding to therapies OR
  • Advanced or recurrent endometrial carcinoma OR
  • Advanced or recurrent ovarian carcinoma OR
  • Unresectable (Stage IIIB or IV) NSCLC

• ECOG Performance Status 0-1 (ECOG status of 2 may be considered following discussion and agreement with sponsor)

• Adequate organ and bone marrow function as defined by hematological and serum chemistry limits

• At least 18 years old

• Both men and women must practice adequate contraception

• Informed consent

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Exclusion Criteria

• Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, AKT, or mTOR inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
• Known allergy or hypersensitivity to any of the components of the treatment formulations
• Taking oral corticosteroids chronically or > 1 mg/day warfarin
• Not recovered from the toxic effects of prior therapy
• History of diabetes mellitus.
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	XL147 (SAR245408),	-
1	paclitaxel	-
1	carboplatin	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 175 mg/m2) and carboplatin in subjects with advanced solid tumors	Assessed at periodic visits
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 225 mg/m2) and carboplatin in subjects with NSCLC	Assessed at periodic visits

Secondary Outcome Measures

Name	Time	Method
To investigate the relationship between selected biomarkers and efficacy and safety outcomes	Assessed at periodic visits
To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination	Assessed at periodic visits
To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel	Assessed at periodic visits

Trial Locations

Locations (1)

Investigational Site Number; 🇺🇸 Madison, Wisconsin, United States