Trial record 1 of 1 for:    abt700
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Study of ABT-700 in Subjects With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01472016
First received: October 14, 2011
Last updated: May 19, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
    Objective response rate (complete and partial response), progression-free survival and duration of response


Estimated Enrollment: 124
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472016

Contacts
Contact: Lan Wang 650.454.2024 lan.wang@abbvie.com
Contact: AnnChristine Thastrom 650.454.2045 annchristine.thastrom@abbvie.com

Locations
United States, Arizona
Site Reference ID/Investigator# 64046 Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Site Reference ID/Investigator# 64046         
United States, Illinois
Site Reference ID/Investigator# 66110 Recruiting
Chicago, Illinois, United States, 60637-1470
Principal Investigator: Site Reference ID/Investigator# 66110         
United States, Michigan
Site Reference ID/Investigator# 57555 Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Site Reference ID/Investigator# 57555         
United States, North Carolina
Site Reference ID/Investigator# 66111 Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Site Reference ID/Investigator# 66111         
Australia
Site Reference ID/Investigator# 65842 Withdrawn
East Melbourne, Australia, 3002
Korea, Republic of
Site Reference ID/Investigator# 75774 Recruiting
Seoul, Korea, Republic of, 138-736
Principal Investigator: Site Reference ID/Investigator# 75774         
Taiwan
Site Reference ID/Investigator# 82302 Recruiting
Tainan, Taiwan, 704
Principal Investigator: Site Reference ID/Investigator# 82302         
Site Reference ID/Investigator# 75773 Recruiting
Taipei, Taiwan, 10002
Principal Investigator: Site Reference ID/Investigator# 75773         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Louie Naumovski, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01472016     History of Changes
Other Study ID Numbers: M12-375
Study First Received: October 14, 2011
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by AbbVie:
Neoplasms
MET amplification
c-Met overexpression
h224G11

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Docetaxel
Cetuximab
Erlotinib
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014