Loading clinical trials...

COMPLETEDPHASE1

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

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Combination With Paclitaxel and Carboplatin in Subjects With Solid Tumors

NCT00756847•Sanofi

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Investigational Site Number

St Louis, Missouri, United States

Investigational Site Number

Oklahoma City, Oklahoma, United States

Investigational Site Number

Houston, Texas, United States

Investigational Site Number

Madison, Wisconsin, United States

Key Dates

Start Date

September 1, 2008

Primary Completion Date

May 1, 2012

Completion Date

October 1, 2012

Last Updated

April 10, 2013

Enrollment

ACTUAL participants

Conditions

CancerNon-Small Cell Lung CancerEndometrial CarcinomaOvarian Carcinoma

Interventions

XL147 (SAR245408),

DRUG

paclitaxel

DRUG

carboplatin

DRUG

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

NCT05884320

GlandSalivary Gland Cancers

View study

RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial