An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors

AbbVie

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: ABT-806

Study type: Interventional

Funder types: Industry

Identifiers

NCT01406119

M12-326

Details and patient eligibility

About

This is an extension study of ABT-806 for subjects with advanced solid tumors.

Enrollment: 14 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has completed a prior study utilizing ABT-806 or 111ln ABT-806 (ABT 806i) and the Investigator believes that continued treatment with ABT-806 is in the best interest of the subject.
• 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 for a period of 3 months. Female subjects considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year.
• Subject is capable of understanding and complying with parameters as outlined in the protocol and the subject or the subject's legal acceptable representative is able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any or study-specific procedures.

Exclusion criteria

• Subject discontinued ABT-806 or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
• Subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
• Subject is a lactating or pregnant female.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

ABT-806 Arm

Experimental group

Treatment:

Drug: ABT-806