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Study of ABT-165 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01946074
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: paclitaxel Drug: FOLFIRI Drug: ABT-165 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 27, 2013
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort C
ABT-165 plus FOLFIRI
Drug: FOLFIRI
5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and 15.
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 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: paclitaxel
Paclitaxel will be administered by intravenous infusion in 28-day dosing cycles on Day 1, 8, and 15. Paclitaxel may also be administered on Day 22 depending on the dose level the subject receives.
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.



Primary Outcome Measures :
  1. Clinical lab testing [ Time Frame: Up to 30 days after a 24-month treatment period ]
    Hematology, Chemistry, and Urinalysis

  2. Maximum observed serum concentration (Cmax) of ABT-165 [ Time Frame: Up to 60 days after a 24-month of treatment period ]
  3. The terminal elimination half life of ABT-165 [ Time Frame: Up to 60 days after a 24-month treatment period ]
  4. Cardiac assessment [ Time Frame: Up to 30 days after a 24-month treatment period ]
    Electrocardiogram (ECG), echocardiogram (ECHO), basic natriuretic peptide (BNP) and troponin I

  5. Area under the curve (AUC) form time zero to the last measurable concentration AUC (0-t) [ Time Frame: Up to 60 days after a 24-month treatment period ]
    AUC (0-t) = Area under the serum concentration versus time curve form time zero (pre-dose) to the time of the last measurable concentration

  6. Physical exam [ Time Frame: Up to 30 days after a 24-month treatment period ]
    Assessment of normal/abnormal physical findings

  7. Number of participants with Adverse Events [ Time Frame: Up to 60 days after a 24-month treatment period ]
    Collect all adverse events at each visit

  8. Vital signs [ Time Frame: Up to 30 days after a 24-month treatment period ]
    Blood pressure, heart rate, respiratory rate and body temperature


Secondary Outcome Measures :
  1. Duration of overall response (DOR) [ Time Frame: Up to 30 days after a 24-month treatment period ]
    DOR is defined as the time from the subject's initial CR or PR to the time of disease progression

  2. Objective response rate (ORR) [ Time Frame: Up to 30 days after a 24-month treatment period ]
    ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR)

  3. Progression free survival (PFS) [ Time Frame: Up to 30 days after a 24-month treatment period ]
    PFS is defined as the time from the first dose date of ABT-165 to either disease progression or death, whichever occurs first



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.
  • Subject has 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 5 years) of clinically significant pulmonary hypertension, uncontrolled systemic hypertension, hypertensive crisis, congestive heart failure, myocardial infarction, aneurysm or aneurysm repair 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.

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): NCT01946074


Locations
United States, Arizona
HonorHealth Research Institute - Pima
Scottsdale, Arizona, United States, 85258-2351
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85260
United States, California
UCLA
Los Angeles, California, United States, 90095
UC Davis Comp Cancer Ctr
Sacramento, California, United States, 95817
Stanford Univ School of Med
Stanford, California, United States, 94305
United States, Illinois
Illinois Cancer Care, PC
Peoria, Illinois, United States, 61615
United States, Indiana
Horizon Oncology Research
Lafayette, Indiana, United States, 47905
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Research Institut
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Center
Dallas, Texas, United States, 75230
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01946074     History of Changes
Other Study ID Numbers: M14-006
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
cancer
neoplasm
advanced solid tumor
colorectal cancer

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action