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Study of ABT-700 in Subjects With Advanced Solid Tumors

NCT01472016 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-11-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ABT-700

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.

DRUG

docetaxel

Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.

DRUG

FOLFIRI

5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.

DRUG

cetuximab

Cetuximab will be administered by intravenous infusion weekly.

DRUG

erlotinib

Erlotinib will be taken orally daily.

DRUG

ABT-700

ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Louie Naumovski, MD · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-06
Primary Completion
2017-04-27
Completion
2017-04-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472016 on ClinicalTrials.gov