Know Cancer

forgot password

An Extension Study of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

An Extension Study of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

This study is designed to evaluate the safety of linifanib in subjects with advanced or
metastatic solid tumors.

Inclusion Criteria

Inclusion Criteria

1. Subject has completed a previous study utilizing linifanib (per the criteria in the
previous study) or was active and assigned to linifanib when the study was completed
and the investigator believes that continued treatment with linifanib is in the best
interest of the subject.

2. Women of childbearing potential and men must agree to use adequate contraception (one
of the following listed below) prior to study entry, for the duration of study
participation and up to 90 days following completion of therapy. Women of
childbearing potential must have a negative urine pregnancy test within 7 days prior
to initiation of treatment and/or post menopausal women must be amenorrheic for at
least 12 months to be considered of non-childbearing potential:

- total abstinence from sexual intercourse (minimum one complete menstrual cycle);

- vasectomized partner(s);

- Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months
prior to study drug administration; if the subject is currently using a hormonal
contraceptive, she should also use a barrier method during this study and for 1
month after study completion;

- intrauterine device (IUD);

- double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring
with spermicidal jellies or creams);

- Additionally, male subjects (including those who are vasectomized) whose
partners are pregnant or might be pregnant must agree to use condoms for the
duration of the study and for 90 days following completion of therapy.

3. Is capable of understanding and complying with parameters as outlined in the protocol
and able to sign the informed consent, approved by an Independent Ethic Committee
(IEC)/Institutional Review Board (IRB) prior to the initiation of any screening or
study-specific procedures.

Exclusion Criteria

1. Subject discontinued linifanib administration before completing the prior study (due
to disease progression, toxicity, withdrawal of consent, other).

2. Subject has any medical condition which in the opinion of the investigator places the
subject at an unacceptably high risk for toxicities.

3. Subject is a lactating or pregnant female.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.

Outcome Description:

The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.

Outcome Time Frame:

All adverse events occuring through the Final Visit will be reported.

Safety Issue:


Principal Investigator

Mark D. McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

June 2012

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms



Site Reference ID/Investigator# 53006 Tucson, Arizona  85724-5024
Site Reference ID/Investigator# 53003 Baltimore, Maryland  21231
Site Reference ID/Investigator# 62482 Detroit, Michigan  48201
Site Reference ID/Investigator# 53004 Lebanon, New Hampshire  03756-0001
Site Reference ID/Investigator# 53007 San Antonio, Texas  78229
Site Reference ID/Investigator# 53008 Tacoma, Washington  98405
Site Reference ID/Investigator# 53005 Madison, Wisconsin  53792