Trial record 1 of 1 for:    NCT01946074
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Study of ABT-165 in Subjects With Advanced Solid Tumors

This study has suspended participant recruitment.
(Study delayed)
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01946074
First received: September 17, 2013
Last updated: August 18, 2014
Last verified: August 2014

September 17, 2013
August 18, 2014
August 2013
July 2015   (final data collection date for primary outcome measure)
  • Number of participants with Adverse Events [ Time Frame: Up to 90 days after a 24-month treatment period ] [ Designated as safety issue: Yes ]
    Collect all adverse events at each visit
  • Vital signs [ Time Frame: Up to 30 days after a 24-month treatment period ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate, respiratory rate and body temperature
  • Physical exam [ Time Frame: Up to 30 days after a 24-month treatment period ] [ Designated as safety issue: Yes ]
    Assessment of normal/abnormal physical findings
  • Clinical lab testing [ Time Frame: Up to 30 days after a 24-month treatment period ] [ Designated as safety issue: Yes ]
    Hematology, Chemistry, and Urinalysis
  • Cardiac assessment [ Time Frame: Up to 30 days after a 24-month treatment period ] [ Designated as safety issue: Yes ]
    Electrocardiogram (ECG), chest X-ray, echocardiogram (ECHO) or multigated acquisition (MUGA), basic natriuretic peptide (BNP) and troponin I
  • Maximum observed serum concentration (Cmax) of ABT-165 [ Time Frame: Up to 90 days after a 24-month of treatment period ] [ Designated as safety issue: No ]
  • The terminal elimination half life of ABT-165 [ Time Frame: Up to 90 days after a 24-month treatment period ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) form time zero to the last measurable concentration AUC (0-t) [ Time Frame: Up to 90 days after a 24-month treatment period ] [ Designated as safety issue: No ]
    AUC (0-t) = Area under the serum concentration versus time curve form time zero (pre-dose) to the time of the last measurable concentration
Same as current
Complete list of historical versions of study NCT01946074 on ClinicalTrials.gov Archive Site
  • Objective response rate (ORR) [ Time Frame: Up to 30 days after a 24-month treatment period ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR)
  • Progression free survival (PFS) [ Time Frame: Up to 30 days after a 24-month treatment period ] [ Designated as safety issue: No ]
    PFS is defined as the time from the first dose date of ABT-165 to either disease progression or death, whichever occurs first
  • Duration of overall response (DOR) [ Time Frame: Up to 30 days after a 24-month treatment period ] [ Designated as safety issue: No ]
    DOR is defined as the time from the subject's initial CR or PR to the time of disease progression
Same as current
Not Provided
Not Provided
 
Study of ABT-165 in Subjects With Advanced Solid Tumors
A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin 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-165 in subjects with advanced solid tumors. The early clinical development plan for ABT-165 is based on the activity demonstrated in preclinical models.

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-165
    ABT-165 will be administered by intravenous infusion at escalating dose levels in 28-day dosing cycles on Day 1 and 15.
  • Drug: paclitaxel
    Paclitaxel will be administered by intravenous infusion in 28-day dosing cycles on Day 1, 8 and 15.
  • Drug: FOLFIRI
    5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and 15.
  • Experimental: Cohort A
    ABT-165 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-165
    Intervention: Drug: ABT-165
  • Experimental: Cohort B
    ABT-165 plus paclitaxel
    Interventions:
    • Drug: ABT-165
    • Drug: paclitaxel
  • Experimental: Cohort C
    ABT-165 plus FOLFIRI
    Interventions:
    • Drug: ABT-165
    • Drug: FOLFIRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
75
July 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • Subject has adequate bone marrow, renal, hepatic and coagulation function.
  • Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment. Female subject considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year. Women of childbearing potential and men must agree to use adequate contraception.
  • Subjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.

Exclusion Criteria:

  • Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.
  • Subject has known uncontrolled metastases to the central nervous system (CNS).
  • Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
  • Subject has history (within previous 2 years) of hypertensive crisis, congestive heart failure, myocardial infarction or the left ventricular ejection fraction (LVEF) less than or equal to 50%.
  • Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects with colorectal cancer will be excluded from the combination therapy cohorts.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01946074
M14-006
No
AbbVie
AbbVie
Not Provided
Study Director: Louie Naumovski, MD AbbVie
AbbVie
August 2014

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