A Study of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Adults With Advanced Malignancies

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: NCT00475917
Recruitment Status : Terminated
First Posted : May 21, 2007
Last Update Posted : August 21, 2015
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine a safe dose of XL844 in combination with gemcitabine, how often it should be taken, and how well people with cancer tolerate the combination of gemcitabine and XL844.

Condition or disease Intervention/treatment Phase
Cancer Lymphoma Drug: XL844 Drug: Gemcitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 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, Pharmacokinetics, and Pharmacodynamics of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Subjects With Advanced Malignancies
Study Start Date : May 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: XL844
Gelatin capsules supplied as 5-mg, 25-mg, and 100-mg strengths; twice-weekly dosing.

Drug: Gemcitabine
once-weekly 30-minute IV infusion

Primary Outcome Measures :
  1. Safety and tolerability of XL844 as a single agent and in combination with gemcitabine when administered orally to subjects with advanced malignancies [ Time Frame: Assessed at each visit/periodic visits ]
  2. Determine the Combination maximum tolerated dose and dose-limiting toxicities for XL844 alone and in combination with gemcitabine [ Time Frame: Assessed at periodic visits ]
  3. Evaluate plasma pharmacokinetics and estimate renal elimination of XL844 as a single agent and in combination with gemcitabine [ Time Frame: Assessed at periodic visits ]

Secondary Outcome Measures :
  1. (Exploratory:) Assess tumor response after repeated administration of XL844 in combination with gemcitabine in subjects with advanced malignancies [ Time Frame: Assessed at periodic visits ]
  2. Pharmacodynamic correlates of XL844 activity in tumor tissue [ Time Frame: Assessed at periodic visits ]

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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 advanced malignancy (solid tumor or lymphoma) that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known 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 has an ECOG (Eastern Cooperative Oncology Group) performance status of ≤2.
  5. The subject has adequate organ and marrow function.
  6. The subject has the capability of understanding the informed consent document and has signed the informed consent document.
  7. Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
  8. Female subjects of childbearing potential must have a negative pregnancy test at screening.
  9. If a subject has received more than three prior regimens of cytotoxic chemotherapy, more than two biologic regimens, or more than 3000 cGy to >25% of his or her bone marrow, the investigator must discuss with the sponsor regarding subject suitability before enrollment.
  10. 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, and has had 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, immunotherapy, biologic therapy, investigational agent, or hormones) within 14 days prior to the first dose of study drug.
  2. The subject has not recovered to Grade ≤1 from adverse events (AEs) due to investigational agents or other medications administered more than 30 days prior to the first dose of study drug.
  3. The subject has received radiation to >25% of his or her bone marrow within 30 days of XL844 treatment.
  4. The subject has a primary brain tumor or known brain metastases.
  5. The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  6. The subject is pregnant or breastfeeding.
  7. The subject is known to be positive for the human immunodeficiency virus (HIV).
  8. The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
  9. The subject has a known allergy or hypersensitivity to any of the components of the XL844 formulation or gemcitabine.

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): NCT00475917

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators

Responsible Party: Exelixis Identifier: NCT00475917     History of Changes
Other Study ID Numbers: XL844-002
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Keywords provided by Exelixis:
Advanced malignancies
Solid tumor

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs