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

NCT00475917 | Terminated Phase 1

• 1 other identifier: XL844-002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Lymphoma

Keywords

Advanced malignancies; Solid tumor

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability of XL844 as a single agent and in combination with gemcitabine when administered orally to subjects with advanced malignancies

  Assessed at each visit/periodic visits

• Determine the Combination maximum tolerated dose and dose-limiting toxicities for XL844 alone and in combination with gemcitabine

  Assessed at periodic visits

• Evaluate plasma pharmacokinetics and estimate renal elimination of XL844 as a single agent and in combination with gemcitabine

  Assessed at periodic visits

Secondary Outcomes (2)

• (Exploratory:) Assess tumor response after repeated administration of XL844 in combination with gemcitabine in subjects with advanced malignancies

  Assessed at periodic visits

• Pharmacodynamic correlates of XL844 activity in tumor tissue

  Assessed at periodic visits

Study Arms (1)

1

EXPERIMENTAL

Drug: XL844; Drug: Gemcitabine

Interventions

XL844 DRUG

Gelatin capsules supplied as 5-mg, 25-mg, and 100-mg strengths; twice-weekly dosing.

1

Gemcitabine DRUG

once-weekly 30-minute IV infusion

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The subject has disease that is assessable by tumor marker, physical, or radiologic means.
• The subject is ≥18 years old.
• The subject has an ECOG (Eastern Cooperative Oncology Group) performance status of ≤2.
• The subject has adequate organ and marrow function.
• The subject has the capability of understanding the informed consent document and has signed the informed consent document.
• 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 pregnancy test at screening.
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• The subject has received radiation to \>25% of his or her bone marrow within 30 days of XL844 treatment.
• The subject has a primary brain tumor or known brain metastases.
• 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.
• The subject is pregnant or breastfeeding.
• The subject is known to be positive for the human immunodeficiency virus (HIV).
• The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
• The subject has a known allergy or hypersensitivity to any of the components of the XL844 formulation or gemcitabine.

Sponsors & Collaborators

• Exelixis: lead

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (2)