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A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors

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ClinicalTrials.gov Identifier: NCT03311477
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Cancer - Solid Tumors Drug: ABBV-399 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : April 2, 2020
Estimated Study Completion Date : April 2, 2020
Arms and Interventions

Arm Intervention/treatment
Experimental: ABBV-399
ABBV-399 via intravenous administration at escalating dose levels.
Drug: ABBV-399
Intravenous infusion


Outcome Measures

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399 [ Time Frame: Up to 21 days ]
    MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or < 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.

  2. Maximum Observed Concentration (Cmax) [ Time Frame: Up to 24 months ]
    Maximum observed concentration (Cmax)

  3. Time to Cmax (Tmax) [ Time Frame: Up to 24 months ]
    Time to Cmax (Tmax)

  4. Terminal elimination half life (t1/2) [ Time Frame: Up to 24 months ]
    Terminal elimination half life (t1/2)

  5. Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) [ Time Frame: Up to 24 months ]
    AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
    Objective response rate (ORR) is defined as the proportion of participants with a confirmed partial or complete response to the treatment. Evaluation of tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  2. Progression-Free Survival (PFS) Time [ Time Frame: Up to 24 months ]
    PFS time is defined as the time from the participant's first dose of ABBV-399 to either the participant's disease progression or death, whichever occurs first.

  3. Duration of response (DOR) [ Time Frame: Up to 24 months ]
    DOR is defined as the time from the participant's initial objective response to study drug therapy to disease progression or death, whichever occurs first.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant with histologically confirmed advanced solid tumor.
  • Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Participant must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Participant has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue available for analysis.
  • Participant has adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

  • Participant 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 ABBV-399.
  • Participant has known uncontrolled metastases to the central nervous system. Participants with brain metastases are eligible after definitive therapy provided they are asymptomatic off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of ABBV-399.
  • Participant has unresolved clinically significant adverse events >= Grade 2 from prior anticancer therapy except for alopecia or anemia.
  • Participant has had major surgery within 21 days prior to the first dose of ABBV-399.
Contacts and Locations

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): NCT03311477


Contacts
Contact: AbbVie_GK Clinical_Trials_Registration_Desk 81-3-4577-1111 AbbVie_JPN_info_clingov@abbvie.com

Locations
Japan
National Cancer Center Hospital /ID# 166939 Recruiting
Tokyo, Japan
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc AbbVie
More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03311477     History of Changes
Other Study ID Numbers: M16-080
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
Maximally administered dose (MAD)
Advanced solid tumors
ABBV-399
Maximum tolerated dose (MTD)
Cancer
Dose escalation
Pharmacokinetics
Solid tumors

Additional relevant MeSH terms:
Neoplasms