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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756847
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : April 10, 2013
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Cancer Non-Small Cell Lung Cancer Endometrial Carcinoma Ovarian Carcinoma Drug: XL147 (SAR245408), Drug: paclitaxel Drug: carboplatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : October 2012

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 Name: Taxol®

Drug: carboplatin
Intravenous injection dosed once every three weeks

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00756847

United States, Missouri
Investigational Site Number
St. Louis, Missouri, United States, 63110
United States, Oklahoma
Investigational Site Number
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Investigational Site Number
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Investigational Site Number
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00756847     History of Changes
Other Study ID Numbers: TED11435
XL147-003 ( Other Identifier: (Other study code) )
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Sanofi:
Solid Tumors
Ovarian Cancer
Endometrial Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Endometrial Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents