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Completed

NCT Number: NCT03311477

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

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

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Key information

Conditions

Advanced Solid Tumors Cancer Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shizuoka Cancer Center /ID# 166940, Sunto-gun, Shizuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-399

Drug

Intravenous infusion

Primary outcomes

  1. 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.

  2. 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.

  3. Terminal elimination half life (t1/2)

    Time frame: Up to 24 months

    Terminal elimination half life (t1/2)

  4. Maximum Observed Concentration (Cmax)

    Time frame: Up to 24 months

    Maximum observed concentration (Cmax)

  5. Time to Cmax (Tmax)

    Time frame: Up to 24 months

    Time to Cmax (Tmax)

Secondary outcomes

  1. 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.

  2. 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.

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2017
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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