Study of ABT-700 in Subjects With Advanced Solid Tumors

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01472016
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ABT-700 — DRUG
    ABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.
  • docetaxel — DRUG
    Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
  • FOLFIRI — DRUG
    5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
  • cetuximab — DRUG
    Cetuximab will be administered by intravenous infusion weekly.
  • erlotinib — DRUG
    Erlotinib will be taken orally daily.
  • ABT-700 — DRUG
    ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.

Study Details

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.

Key Dates

First listed
Nov 16, 2011
Start date
Oct 6, 2011
Status verified
Jun 2017
Primary completion
Apr 27, 2017
Completion
Apr 27, 2017

Study Design

Enrollment
74 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700.
  • Experimental: Cohort B
    ABT-700 plus docetaxel.
  • Experimental: Cohort C
    ABT-700 plus FOLFIRI/cetuximab
  • Experimental: Cohort D
    ABT-700 plus erlotinib

Primary Outcome Measure

To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib [ Time Frame: First cycle of treatment through 60 day follow-up visit ]

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