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

Sponsored by:	Exelixis
Information provided by:	Exelixis
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 Drug: paclitaxel Drug: carboplatin	Phase I

MedlinePlus related topics: Cancer Lung Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 in Combination With Paclitaxel and Carboplatin in Subjects With Solid Tumors

Further study details as provided by Exelixis:

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:	66
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: XL147 Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing Drug: paclitaxel Intravenous injection dosed once every three weeks 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: PRA Contact Line

1-800-251-8124

Locations

United States, Texas
M. D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Susan Tse, RN 713-794-1014 stse@mdanderson.org
Principal Investigator: Jennifer Wheler, MD
United States, Wisconsin
University of WI Paul P Carbone Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Howard Bailey, MD

Sponsors and Collaborators

Exelixis

More Information

No publications provided

Responsible Party:	Exelixis, Inc. ( Christian Scheffold, MD, PhD/Director, Clinical Research )
Study ID Numbers:	XL147-003
Study First Received:	September 18, 2008
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00756847 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

Solid Tumors
NSCLC
Ovarian Cancer
Endometrial Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Gonadal Disorders
Urogenital Neoplasms
Endometrial Cancer
Ovarian Diseases
Genital Diseases, Female
Endometrial Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Uterine Neoplasms
Ovarian Cancer
Endocrine Gland Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female

Endocrine System Diseases
Uterine Diseases
Antimitotic Agents
Carboplatin
Ovarian Epithelial Cancer
Carcinoma
Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Endocrinopathy
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Uterine Neoplasms
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Ovarian Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Uterine Diseases
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Adnexal Diseases
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators

ClinicalTrials.gov processed this record on May 07, 2009