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A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors

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

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Trial Information

A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors

Inclusion Criteria:

- Confirmed diagnosis of:

- Advanced solid tumor that is no longer responding to therapies OR

- Advanced or metastatic NSCLC that has previously been treated with erlotinib or

- ECOG Performance Status 0-1

- Adequate organ and bone arrow 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, cytotoxic
chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase
inhibitors, non-cytotoxic hormonal agents

- Erlotinib intolerant

- Taking oral corticosteroids chronically or > 1 mg/day warfarin

- Not recovered from the toxic effects of prior therapy

- History of diabetes mellitus and an HgbA1c > 7%

- 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:

Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib

Outcome Time Frame:

Assessed during 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:

August 2008

Completion Date:

February 2011

Related Keywords:

  • Cancer
  • Non-Small Cell Lung Cancer
  • Cancer
  • Solid Tumors
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Investigational Site Number 168983Philadelphia, Pennsylvania  19111