Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor

Solid Tumor Clinical Trial

Official title:

A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250170
• Other study ID #: 317-KOA-1401i
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2014
• Est. completion date: March 8, 2019

Study information

• Verified date: September 2019
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid tumor. Subsequently, an expansion part will further evaluate the biomarker, safety, pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.

Description:

This trial is designed to determine the safety, tolerability, maximum tolerated dose and recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle) to subjects with advanced solid tumor in the dose escalation part so that biomarkers, efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose escalation design for a small sample size.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Pathologically and/or cytologically confirmed advanced solid tumor

2. Patients who were refractory to standard therapy or for which there are no standard treatment options available

3. Age 20 to 80 years at the time of informed consent

4. Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration

5. Patients informed of the diagnosis of advanced solid tumor who are fully informed about the content of the study by the investigator or subinvestigator using the specified written consent form and other written explanation, and give written consent to participate in the study of their free will

6. Patients who are able to take oral medication

Exclusion Criteria:

1. Patients with symptomatic brain metastases

2. Patients who have not recovered from any prior therapy related toxicity deemed to be clinically significant at study entry, except for the test item defined in inclusion criteria.

3. Patients with active infections needing whole body therapy

4. Patients with positive hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody

5. Patients with positive human immunodeficiency virus (HIV) antibody

6. Patients with uncontrollable cardiac diseases

7. Patients with uncontrollable pain by analgesic drugs

8. Patients with a history of organ transplantation

9. Patients who have received another IMP

10. Patients who are pregnant, possibly pregnant, or lactating

11. Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• OPB-111077
Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on & 3 days-off (21 days=1cycle)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants with Adverse Events	21 days
Primary	Maximum tolerated dose	The highest dose that does not lead to discontinuation of dose escalation	21 days
Primary	Biomarker of OPB-111077	Change from baseline on predictable biomarker specified in the protocol	21 days
Secondary	Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment	Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the final study visit.	3~18 weeks depending on tumor response
Secondary	Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.	The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.	21 days