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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: linifanib

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: linifanib	Drug: linifanib; QD daily; Other Names: ABT-869

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.	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.	All adverse events occuring through the Final Visit will be reported.
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.	Physical exam, blood pressure, pulse, body temperature will be measured and recorded on the case report forms.	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.
Safety: Multiple Gated Acquisition (MUGA) will be assessed at specified time points as a measure of safety.	MUGA	Change from baseline to every 12 weeks
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
There are no secondary outcome measures specified for this study.	There are no secondary outcome measures specified for this study.	There are no secondary outcome measures specified for this study.

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Mark D. McKee, MD, Abbott

Publications and helpful links

Helpful Links

• study results abstract

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: M12-749