An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01413893
First received: June 23, 2011
Last updated: August 1, 2012
Last verified: June 2012
  Purpose

An extension study of linifanib in subjects with advanced or metastatic solid tumors.


Condition Intervention Phase
Advanced Solid Tumors
Drug: linifanib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Extension Study of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: All adverse events occuring through the Final Visit will be reported. ] [ Designated as safety issue: Yes ]
    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.

  • Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [ Time Frame: Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit. ] [ Designated as safety issue: Yes ]
    Physical exam, blood pressure, pulse, body temperature will be measured and recorded on the case report forms.

  • Safety: Multiple Gated Acquisition (MUGA) will be assessed at specified time points as a measure of safety. [ Time Frame: Change from baseline to every 12 weeks ] [ Designated as safety issue: Yes ]
    MUGA

  • Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [ Time Frame: Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit ] [ Designated as safety issue: Yes ]
    Chemistry, hematology, urinalysis lab tests will be measured and recorded on the case report forms. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.


Secondary Outcome Measures:
  • There are no secondary outcome measures specified for this study. [ Time Frame: There are no secondary outcome measures specified for this study. ] [ Designated as safety issue: No ]
    There are no secondary outcome measures specified for this study.


Enrollment: 35
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linifanib Drug: linifanib
QD daily
Other Name: ABT-869

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01413893

Locations
United States, Arizona
Site Reference ID/Investigator# 53006
Tucson, Arizona, United States, 85724-5024
United States, Maryland
Site Reference ID/Investigator# 53003
Baltimore, Maryland, United States, 21231
United States, Michigan
Site Reference ID/Investigator# 62482
Detroit, Michigan, United States, 48201
United States, New Hampshire
Site Reference ID/Investigator# 53004
Lebanon, New Hampshire, United States, 03756-0001
United States, Texas
Site Reference ID/Investigator# 53007
San Antonio, Texas, United States, 78229
United States, Washington
Site Reference ID/Investigator# 53008
Tacoma, Washington, United States, 98405
United States, Wisconsin
Site Reference ID/Investigator# 53005
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Abbott
Investigators
Study Director: Mark D. McKee, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01413893     History of Changes
Other Study ID Numbers: M12-749
Study First Received: June 23, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014