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.
Verified January 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: January 28, 2014
Last verified: January 2014

October 14, 2011
January 28, 2014
October 2011
December 2014   (final data collection date for 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 ] [ 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 ]
  • Safety (Number of subjects with adverse events and/or dose-limiting toxicities) [ Time Frame: Assessments will be made at three time points during the first 21 day cycle, once per cycle thereafter up to one year or until therapy is deemed unsatisfactory as evidenced by clinically significant progression of disease, plus 30 days after last dose. ] [ Designated as safety issue: Yes ]
    Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring
  • Pharmacokinetics of ABT-700 when administered as monotherapy and in combination with erlotinib or with XELOX including maximum observed plasma concentration (Cmax) and other variables. [ Time Frame: Samples will be taken at three time points during the first 21 day cycle, once per cycle thereafter up to one year or until therapy is deemed unsatisfactory as evidenced by clinically significant progression of disease, plus 30 days after last dose. ] [ Designated as safety issue: Yes ]
    Blood samples for assay of ABT-700
Complete list of historical versions of study NCT01472016 on ClinicalTrials.gov Archive Site
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
  • QT Assessment [ Time Frame: Assessments will be made several times during the first four administrations, plus 30 days after last dose. ] [ Designated as safety issue: Yes ]
    Triplicate ECGs
  • Pharmacodynamics of ABT-700 when administered as monotherapy and in combination with erlotinib or with XELOX to define the relationship between drug concentration and disease status. [ Time Frame: Samples will be taken at three time points during the first 21 day cycle, once per cycle thereafter up to one year or until therapy is deemed unsatisfactory as evidenced by clinically significant progression of disease, plus 30 days after last dose. ] [ Designated as safety issue: No ]
    Pharmacodynamics of ABT-700 analyzed from blood samples.
Not Provided
Not Provided
 
Study of ABT-700 in Subjects With Advanced Solid Tumors
A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
  • 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.
  • 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.
    Intervention: Drug: ABT-700
  • Experimental: Cohort B
    ABT-700 plus docetaxel.
    Interventions:
    • Drug: ABT-700
    • Drug: docetaxel
  • Experimental: Cohort C
    ABT-700 plus FOLFIRI/cetuximab
    Interventions:
    • Drug: ABT-700
    • Drug: FOLFIRI
    • Drug: cetuximab
    • Drug: ABT-700
  • Experimental: Cohort D
    ABT-700 plus erlotinib
    Interventions:
    • Drug: ABT-700
    • Drug: erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Cynthia Porter 650.454.2143 cynthia.porter@abbvie.com
Contact: Lan Wang 650.454.2024 lan.wang@abbvie.com
United States,   Australia,   Korea, Republic of,   Taiwan
 
NCT01472016
M12-375
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Louie Naumovski, MD AbbVie
AbbVie
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP