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Completed

NCT Number: NCT00756847

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

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Key information

Conditions

Cancer Adnexal Diseases Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number, St Louis, Missouri, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XL147 (SAR245408),

Drug

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

paclitaxel

Drug

Intravenous injection dosed once every three weeks

Other names: Taxol®

carboplatin

Drug

Intravenous injection dosed once every three weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2008
Registry last updated
Apr 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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