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 : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer - Solid Tumors||Drug: ABBV-399||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 6, 2017|
|Estimated Primary Completion Date :||June 19, 2019|
|Estimated Study Completion Date :||June 19, 2019|
ABBV-399 via intravenous administration at escalating dose levels.
- 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.
- 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.
- Terminal elimination half life (t1/2) [ Time Frame: Up to 24 months ]Terminal elimination half life (t1/2)
- Maximum Observed Concentration (Cmax) [ Time Frame: Up to 24 months ]Maximum observed concentration (Cmax)
- Time to Cmax (Tmax) [ Time Frame: Up to 24 months ]Time to Cmax (Tmax)
- 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.
- 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.
- 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.
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
|Contact: AbbVie GK Clinical Trial Registration Deskfirstname.lastname@example.org|
|Shizuoka Cancer Center||Recruiting|
|Sunto-gun, Shizuoka, Japan, 411-8777|
|National Cancer Center Hosp||Recruiting|
|Chuo-ku, Tokyo, Japan, 104-0045|
|Study Director:||AbbVie Inc.||AbbVie|