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

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00756847

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 I

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:

MedlinePlus related topics: Cancer Lung Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	74
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2012
Estimated 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

Contacts

Contact: For site information, send an email with site number to

Contact-Us@sanofi-aventis.com

Locations

United States, Missouri
Investigational Site Number 114144	Recruiting
St. Louis, Missouri, United States, 63110
United States, Texas
Investigational Site Number 168442	Recruiting
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Investigational Site Number 168443	Recruiting
Madison, Wisconsin, United States, 53792-6164

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00756847 History of Changes
Other Study ID Numbers:	TED11435, XL147-003
Study First Received:	September 18, 2008
Last Updated:	September 19, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

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
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012