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

Advanced Solid Tumors Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311477
• Other study ID #: M16-080
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2017
• Est. completion date: March 4, 2019

Study information

• Verified date: March 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 4, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors Cancer
• Neoplasms

Intervention

Drug:
• ABBV-399
Intravenous infusion

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital /ID# 166939	Chuo-ku	Tokyo
Japan	Shizuoka Cancer Center /ID# 166940	Sunto-gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)	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.	Up to 24 months
Primary	Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399	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.	Up to 21 days
Primary	Terminal elimination half life (t1/2)	Terminal elimination half life (t1/2)	Up to 24 months
Primary	Maximum Observed Concentration (Cmax)	Maximum observed concentration (Cmax)	Up to 24 months
Primary	Time to Cmax (Tmax)	Time to Cmax (Tmax)	Up to 24 months
Secondary	Progression-Free Survival (PFS) Time	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.	Up to 24 months
Secondary	Objective Response Rate (ORR)	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.	Up to 24 months
Secondary	Duration of response (DOR)	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.	Up to 24 months