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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

Phase 1
18 Years
Not Enrolling
Cancer, Non-Small Cell Lung Cancer, Endometrial Carcinoma, Ovarian Carcinoma

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Assessed at periodic visits

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

October 2012

Related Keywords:

  • Cancer
  • Non-Small Cell Lung Cancer
  • Endometrial Carcinoma
  • Ovarian Carcinoma
  • Solid Tumors
  • Ovarian Cancer
  • Endometrial Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Adenoma
  • Endometrial Neoplasms



Investigational Site NumberSt. Louis, Missouri  63110
Investigational Site NumberOklahoma City, Oklahoma  73104
Investigational Site NumberHouston, Texas  77030-4009
Investigational Site NumberMadison, Wisconsin  53792-6164