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

This study has been terminated.
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00475917
First received: May 17, 2007
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Cancer
Lymphoma
Drug: XL844
Drug: Gemcitabine
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, Pharmacokinetics, and Pharmacodynamics of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Subjects With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Determine the Combination maximum tolerated dose and dose-limiting toxicities for XL844 alone and in combination with gemcitabine [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
  • Evaluate plasma pharmacokinetics and estimate renal elimination of XL844 as a single agent and in combination with gemcitabine [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • (Exploratory:) Assess tumor response after repeated administration of XL844 in combination with gemcitabine in subjects with advanced malignancies [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • Pharmacodynamic correlates of XL844 activity in tumor tissue [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: May 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475917

Locations
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
Exelixis
  More Information

No publications provided

Responsible Party: Salim Yazji, MD/Senior Director, Clinical Research, Exelixis, Inc.
ClinicalTrials.gov Identifier: NCT00475917     History of Changes
Other Study ID Numbers: XL844-002
Study First Received: May 17, 2007
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
Advanced malignancies
Solid tumor

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 16, 2014