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A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL765 Administered Orally Daily to Subjects With Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL765 Administered Orally Daily to Subjects With Solid Tumors

Inclusion Criteria:

- The subject has a histologically confirmed metastatic or unresectable solid tumor for
which standard curative or palliative measures do not exist or are no longer
effective, and there are no therapies known to prolong survival.

- The subject has disease that is assessable by tumor marker, physical, or radiologic

- The subject is at least 18 years old.

- The subject's weight is at lease 40 kg.

- The subject has an Eastern Cooperative Oncology Group performance status of 0 - 2.

- The subject has adequate organ and bone marrow function.

- The subject has fasting plasma glucose < 120 mg/dL at screening.

- for subjects who are to be enrolled into the Expanded MTD Cohort and Lower-Dose Tumor
Genetic Alteration Subjects:

1. tumor tissue amenable to serial biopsy;

2. additional informed consent

- The subject is capable of understanding the protocol and has signed the informed

- Sexually active subjects (male and female) must use medically acceptable methods of
contraception during the course of the study.

- Female subjects of childbearing potential must have a negative serum pregnancy test
at screening.

- If the subject has received more than 3 prior regimens of cytotoxic chemotherapy,
more than 2 biologic regimens, or more than 3000 cGy to >25% of his or her bone
marrow, the sponsor must determine subject suitability before enrollment.

- The subject has had no other diagnosis of malignancy (unless non-melanoma skin
cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥ 2 years ago, and
has had no evidence of disease for 2 years prior to screening for this study.)

Exclusion Criteria:

- The subject has received anticancer treatment (chemotherapy, radiotherapy, cytokines,
or hormones) within 30 days (6 weeks for nitrosoureas, mitomycin C, or bicalutamide)
before the first dose of XL765.

- The subject has received radiation to > 25% of his or her bone marrow.

- The subject has not recovered from adverse events, except Grade 2 alopecia, due to
other investigational or other agents administered prior to study enrollment.

- The subject has received another investigational agent within 30 days or the first
dose of XL765 or a small-molecule kinase inhibitor within 14 days or 5 half-lives.

- The subject is known to have diabetes

- The subject has uncontrolled intercurrent illness including ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac

- The subject has psychiatric illness/social situation that would limit compliance with
study requirements.

- The subject is pregnant or breast feeding.

- The subject is known to be positive for HIV.

- The subject has a known allergy or hypersensitivity to components of the XL765

- The subject has a baseline corrected QT interval > 450 ms.

Type of Study:


Study Design:

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

Outcome Measure:

Safety, tolerability, and maximum tolerated dose (MTD) of daily oral administration of XL765 in two treatment schedules

Outcome Time Frame:

Assessed at each visit/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:

June 2007

Completion Date:

September 2012

Related Keywords:

  • Cancer
  • Cancer
  • Solid Tumors



Investigational Site Number 1402 San Antonio, Texas  78229
Investigational Site Number 1302 Detroit, Michigan  48201
Investigational Site Number 1435 Omaha, Nebraska  68198