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

April 9, 2013 updated by: Sanofi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Investigational Site Number
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Investigational Site Number
    • Texas
      • Houston, Texas, United States, 77030-4009
        • Investigational Site Number
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • Investigational Site Number

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: XL147 (SAR245408),
Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing
Drug: paclitaxel
Intravenous injection dosed once every three weeks
Other Names:
  • Taxol®
Drug: carboplatin
Intravenous injection dosed once every three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Assessed at periodic visits
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
Time Frame: Assessed at periodic visits
Assessed at periodic visits

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TED11435
  • XL147-003 (Other Identifier: (Other study code))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on XL147 (SAR245408),

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe