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Study of ABT-700 in Subjects With Advanced Solid Tumors

NCT ID: NCT01472016

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-06

Study Completion Date

2017-04-27

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Keywords

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c-Met overexpression MET amplification Neoplasms h224G11

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ABT-700

Intervention Type 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.

Cohort B

ABT-700 plus docetaxel.

Group Type EXPERIMENTAL

ABT-700

Intervention Type 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

Intervention Type DRUG

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

Cohort C

ABT-700 plus FOLFIRI/cetuximab

Group Type EXPERIMENTAL

ABT-700

Intervention Type 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.

FOLFIRI

Intervention Type DRUG

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

cetuximab

Intervention Type DRUG

Cetuximab will be administered by intravenous infusion weekly.

ABT-700

Intervention Type DRUG

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

Cohort D

ABT-700 plus erlotinib

Group Type EXPERIMENTAL

ABT-700

Intervention Type 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.

erlotinib

Intervention Type DRUG

Erlotinib will be taken orally daily.

Interventions

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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.

Intervention Type DRUG

docetaxel

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

Intervention Type DRUG

FOLFIRI

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

Intervention Type DRUG

cetuximab

Cetuximab will be administered by intravenous infusion weekly.

Intervention Type DRUG

erlotinib

Erlotinib will be taken orally daily.

Intervention Type DRUG

ABT-700

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification.
* Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.
* Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.

Exclusion Criteria

* Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700.
* Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.
* Subject has unresolved adverse events \> Grade 1 from prior anticancer therapy except for alopecia or anemia.
* Subject has had major surgery within 21 days prior to the first dose of ABT-700.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louie Naumovski, MD

Role: STUDY_DIRECTOR

AbbVie

Countries

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Australia South Korea Taiwan United States

Related Links

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http://ascopubs.org/doi/abs/10.1200/jco.2015.33.3_suppl.167

study results abstract

Other Identifiers

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M12-375

Identifier Type: -

Identifier Source: org_study_id