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

NCT ID: NCT01413893

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

Brief Summary

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

Detailed Description

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

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

linifanib

Group Type: EXPERIMENTAL

linifanib

Intervention Type: DRUG

QD daily

Interventions

linifanib

QD daily

Intervention Type: DRUG

Other Intervention Names

ABT-869

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark D. McKee, MD

Role: STUDY_DIRECTOR

Abbott

Countries

United States

Related Links

http://ascopubs.org/doi/abs/10.1200/jco.2010.28.15_suppl.3053

study results abstract

Other Identifiers

M12-749

Identifier Type: -

Identifier Source: org_study_id