Clinical Trials /

A Study of ABT-165 in Subjects With Solid Tumors

NCT01946074

Description:

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B, C and D were completed.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of ABT-165 in Subjects With Advanced Solid Tumors
  • Official Title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: M14-006
  • NCT ID: NCT01946074

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
ABT-165Cohort A
paclitaxelCohort B
FOLFIRICohort C

Purpose

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 in subjects with advanced solid tumors. The early clinical development plan for ABT-165 is based on the activity demonstrated in preclinical models.

Trial Arms

NameTypeDescriptionInterventions
Cohort AExperimentalABT-165 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-165
  • ABT-165
Cohort BExperimentalABT-165 plus paclitaxel
  • ABT-165
  • paclitaxel
Cohort CExperimentalABT-165 plus FOLFIRI
  • ABT-165
  • FOLFIRI

Eligibility Criteria

        Inclusion Criteria:

          -  Subject must have advanced solid tumor that is not amenable to surgical resection or
             other approved therapeutic options that have demonstrated clinical benefit.

          -  Subject has adequate bone marrow, renal, hepatic and coagulation function.

          -  Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors
             (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including
             but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).

          -  Women of childbearing potential must have a negative serum pregnancy test within 14
             days prior to initiation of treatment. Female subject considered not of childbearing
             potential must be documented as being surgically sterile or post-menopausal for at
             least 1 year. Women of childbearing potential and men must agree to use adequate
             contraception.

          -  Subjects in the combination therapy cohorts must meet the above inclusion criteria
             and be eligible to receive paclitaxel or FOLFIRI per most current prescribing
             information, or at the discretion of the Investigator.

        Exclusion Criteria:

          -  Subject has received anticancer therapy including chemotherapy, radiation therapy,
             immunotherapy, biologic, or any investigational therapy within a period of 21 days or
             anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.

          -  Subject has uncontrolled metastases to the central nervous system (CNS).

          -  Subject has unresolved clinically significant toxicities from prior anticancer
             therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade
             2 or higher.

          -  Subject has history (within previous 5 years) of clinically significant pulmonary
             hypertension, uncontrolled systemic hypertension, hypertensive crisis, congestive
             heart failure, myocardial infarction, aneurysm or aneurysm repair or the left
             ventricular ejection fraction (LVEF) less than or equal to 50%.

          -  Subjects enrolled on the combination therapy phase must not meet the above exclusion
             criteria and must be eligible to receive paclitaxel or FOLFIRI per most current
             prescribing information, or at the discretion of the Investigator.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with Adverse Events
Time Frame:Up to 60 days after a 24-month treatment period
Safety Issue:
Description:Collect all adverse events at each visit

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Up to 30 days after a 24-month treatment period
Safety Issue:
Description:ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR)
Measure:Progression free survival (PFS)
Time Frame:Up to 30 days after a 24-month treatment period
Safety Issue:
Description:PFS is defined as the time from the first dose date of ABT-165 to either disease progression or death, whichever occurs first
Measure:Duration of overall response (DOR)
Time Frame:Up to 30 days after a 24-month treatment period
Safety Issue:
Description:DOR is defined as the time from the subject's initial CR or PR to the time of disease progression

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • advanced solid tumor
  • cancer
  • neoplasm
  • colorectal cancer

Last Updated

April 14, 2017