Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00756847
First received: September 18, 2008
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cancer Non-Small Cell Lung Cancer Endometrial Carcinoma Ovarian Carcinoma |
Drug: XL147 (SAR245408), Drug: paclitaxel Drug: carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To investigate the relationship between selected biomarkers and efficacy and safety outcomes [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
- To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
- To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | September 2008 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756847
Locations
| 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
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00756847 History of Changes |
| Other Study ID Numbers: | TED11435, XL147-003 |
| Study First Received: | September 18, 2008 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Solid Tumors NSCLC Ovarian Cancer Endometrial Cancer |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Ovarian Neoplasms Neoplasms, Glandular and Epithelial Adenoma Endometrial Neoplasms Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Uterine Neoplasms Uterine Diseases Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013