Study of XL418 in Adults With Solid Tumors

This study has suspended participant recruitment.
(Enrollment suspended due to low drug exposure.)
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00460278
First received: April 11, 2007
Last updated: June 2, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Cancer
Solid Tumors
Drug: XL418
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Exelixis:

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

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

Estimated Enrollment: 63
Study Start Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460278

Locations
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
Exelixis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00460278     History of Changes
Other Study ID Numbers: XL418-001
Study First Received: April 11, 2007
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
Cancer
Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014