Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:

Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-8895a in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004717
• Other study ID #: DS8895-A-J101
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: February 2017

Study information

• Verified date: July 2019
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.

• Eastern Cooperative Oncology Group performance status(PS) of 0 or 1

Exclusion Criteria:

• Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

Cardiac failure (NYHA = ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia)

• Severe or uncontrolled concomitant disease.

• Clinically active brain metastases defined as symptomatic or requiring treatment.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• DS-8895a

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants experiencing dose limiting toxicities	to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events	day 1 through day 28
Primary	number of participants experiencing clinical or laboratory adverse events	to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events	from start of treatment to end of treatment, on expected average 12 weeks
Primary	serum pharmacokinetics of DS-8895a	pharmacokinetics (Area Under the Curve-AUC, Terminal Elimination half-life-t1/2, Total Body Clearance) of DS-8895a in Japanese subjects with advanced solid tumors, and also to investigate the recommended dose of DS-8895a for subsequent clinical studies	Cycle 1 - days 1, 2, 4, 8 and 15; Cycle 2-days 1, 2, 4, 8 and 15; Cycle 3 and on- days 1; end of study; 45 days post last dose
Secondary	level of anti-DS-8895a (HAHA) antibody	Human anti-human antibody (HAHA) profile for DS-8895a [Time Frame: Cycle 1 - days 1, and 15; Cycle 2 and on - days 1; end of study; 45 days post last dose] The presence of HAHA (anti-DS-8895a neutralizing antibody) in serum will be assessed"	Cycle 1 days 1 and 15; Cycle 2 day 1; end of study; 45 days post-last-dose
Secondary	disease control rate	proportion of subjects with the best overall response of stable disease or better will be measured every 6 weeks until study drug discontinued.	every 6 weeks
Secondary	pharmacodynamic effects in blood	effects on blood will be determined at day 1 and 2 of each cycle	day 1 and 2
Secondary	pharmacodynamic effects in tumors	effects on tumor cells will be determined at baseline and day 1 of cycle 2	baseline and day 1 of cycle 2
Secondary	objective response rate	sum of complete response and partial response rates measured every 6 weeks until study drug discontinuation	every 6 weeks