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Completed

NCT Number: NCT02004717

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

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.

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Key information

Conditions

Solid Tumors Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

DS-8895a

Drug

Primary outcomes

  1. number of participants experiencing dose limiting toxicities

    Time frame: day 1 through day 28

    to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events

  2. number of participants experiencing clinical or laboratory adverse events

    Time frame: from start of treatment to end of treatment, on expected average 12 weeks

    to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events

  3. serum pharmacokinetics of DS-8895a

    Time frame: 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

    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

Secondary outcomes

  1. level of anti-DS-8895a (HAHA) antibody

    Time frame: Cycle 1 days 1 and 15; Cycle 2 day 1; end of study; 45 days post-last-dose

    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"

  2. disease control rate

    Time frame: every 6 weeks

    proportion of subjects with the best overall response of stable disease or better will be measured every 6 weeks until study drug discontinued.

  3. pharmacodynamic effects in blood

    Time frame: day 1 and 2

    effects on blood will be determined at day 1 and 2 of each cycle

  4. pharmacodynamic effects in tumors

    Time frame: baseline and day 1 of cycle 2

    effects on tumor cells will be determined at baseline and day 1 of cycle 2

  5. objective response rate

    Time frame: every 6 weeks

    sum of complete response and partial response rates measured every 6 weeks until study drug discontinuation

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2013
Registry last updated
Jul 22, 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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