Working… Menu

Study of XL418 in Adults With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460278
Recruitment Status : Suspended (Enrollment suspended due to low drug exposure.)
First Posted : April 13, 2007
Last Update Posted : June 4, 2008
Information provided by:

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of XL418 in subjects with solid tumors. XL418 is a new chemical entity that inhibits a spectrum of targets, including Akt and p70S6K, that mediate PI3 Kinase / PTEN signaling.

Condition or disease Intervention/treatment Phase
Cancer Solid Tumors Drug: XL418 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL418 Administered Orally Daily to Subjects With Solid Tumors
Study Start Date : April 2007

Primary Outcome Measures :
  1. Safety, tolerability, and maximum tolerated dose of XL418 with daily oral administration

Secondary Outcome Measures :
  1. Plasma pharmacokinetics and pharmacodynamic effects of daily oral administration of XL418

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The subject has a histologically confirmed solid tumor that is metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
  2. The subject has disease that is assessable by tumor marker, physical, or radiologic means.
  3. The subject is ≥18 years old.
  4. The subject's weight is ≥55 kg and ≤120 kg.
  5. The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  6. The subject has adequate organ and marrow function.
  7. For subjects who are to be enrolled into the expanded MTD cohort:

    1. tumor tissue amenable to serial biopsy; and
    2. additional informed consent.
  8. The subject is capable of understanding the protocol and has signed the informed consent document.
  9. Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
  10. Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
  11. The subject has a normal fasting blood glucose level at screening.
  12. If a subject has received more than three prior regimens of cytotoxic chemotherapy, more than two biological regimens, or more than 3000 cGy to areas containing substantial marrow, the principal investigator (PI) and the sponsor will discuss subject suitability prior to enrollment.
  13. The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥5 years ago, with no evidence of disease for 5 years prior to screening for this study).

Exclusion Criteria:

  1. The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 30 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug.
  2. The subject has received radiation to ≥25% of his or her bone marrow within 30 days of treatment with XL418.
  3. The subject has not recovered either to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment.
  4. The subject has received another investigational agent within 30 days of the first dose of study drug.
  5. The subject has known brain metastases.
  6. The subject is known to have diabetes.
  7. The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  8. The subject has psychiatric illness/social situations that would limit compliance with study requirements.
  9. The subject is pregnant or breast feeding.
  10. The subject is known to be positive for the human immunodeficiency virus (HIV).
  11. The subject has a known allergy or hypersensitivity to any of the components of the XL418 formulation.
  12. The subject has a baseline QTc interval >450 ms.
  13. The subject is unwilling or unable to abide by the study protocol or cooperate fully with the investigator or designee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00460278

Layout table for location information
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00460278     History of Changes
Other Study ID Numbers: XL418-001
First Posted: April 13, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by Exelixis:
Solid Tumors
Additional relevant MeSH terms:
Layout table for MeSH terms