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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Endometrial Carcinoma; Ovarian Carcinoma; Cancer; Non-Small Cell Lung Cancer

Treatments: Drug: XL147 (SAR245408),; Drug: paclitaxel; Drug: carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00756847

TED11435

XL147-003 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

1

Experimental group

Treatment:

Drug: carboplatin

Drug: XL147 (SAR245408),

Drug: paclitaxel