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Study of ABT-700 in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01472016
First Posted: November 16, 2011
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
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.

Condition Intervention Phase
Advanced Solid Tumors Drug: ABT-700 Drug: docetaxel Drug: FOLFIRI Drug: cetuximab Drug: erlotinib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors

Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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 ]
    Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring

  • To Evaluate the pharmacokinetics 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: At each cycle of treatment through 60 days after last dose. ]
    Pharmacokinetic profile of ABT-700 analyzed from blood samples

  • To determine the recommended Phase 2 dose for ABT-700 [ Time Frame: First cycle of treatment through 60 day follow-up visit ]

Secondary Outcome Measures:
  • To evaluate the preliminary efficacy 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: Screening through 60 day follow-up visit ]
    Objective response rate (complete and partial response), progression-free survival and duration of response


Enrollment: 74
Actual Study Start Date: October 6, 2011
Study Completion Date: April 27, 2017
Primary Completion Date: April 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Experimental: Cohort B
ABT-700 plus docetaxel.
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.
Experimental: Cohort C
ABT-700 plus FOLFIRI/cetuximab
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: 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: ABT-700
ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.
Experimental: Cohort D
ABT-700 plus erlotinib
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: erlotinib
Erlotinib will be taken orally daily.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700.

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.
  • Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472016


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Louie Naumovski, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01472016     History of Changes
Other Study ID Numbers: M12-375
First Submitted: October 14, 2011
First Posted: November 16, 2011
Last Update Posted: November 21, 2017
Last Verified: June 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
c-Met overexpression
MET amplification
Neoplasms
h224G11

Additional relevant MeSH terms:
Docetaxel
Cetuximab
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors