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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Cancer Non-Small Cell Lung Cancer Endometrial Carcinoma Ovarian Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

XL147 (SAR245408),

Intervention Type DRUG

Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing

paclitaxel

Intervention Type DRUG

Intravenous injection dosed once every three weeks

carboplatin

Intervention Type DRUG

Intravenous injection dosed once every three weeks

Interventions

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XL147 (SAR245408),

Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing

Intervention Type DRUG

paclitaxel

Intravenous injection dosed once every three weeks

Intervention Type DRUG

carboplatin

Intravenous injection dosed once every three weeks

Intervention Type DRUG

Other Intervention Names

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Taxol®

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No