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
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: ABT-165
Drug: paclitaxel
Drug: FOLFIRI
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 Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 75
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Experimental: Cohort B
ABT-165 plus paclitaxel
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.
Experimental: Cohort C
ABT-165 plus FOLFIRI
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: FOLFIRI
5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and 15.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01946074

Locations
United States, Arizona
Site Reference ID/Investigator# 105677
Scottsdale, Arizona, United States, 85258
Site Reference ID/Investigator# 105678
Scottsdale, Arizona, United States, 85258
United States, California
Site Reference ID/Investigator# 123758
Stanford, California, United States, 94305
United States, North Carolina
Site Reference ID/Investigator# 105679
Durham, North Carolina, United States, 27710
United States, Texas
Site Reference ID/Investigator# 123757
Dallas, Texas, United States, 75230
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Louie Naumovski, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01946074     History of Changes
Other Study ID Numbers: M14-006
Study First Received: September 17, 2013
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
advanced solid tumor
neoplasm
cancer

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014