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

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ClinicalTrials.gov Identifier: NCT02004717
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: DS-8895a Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-8895a in Subjects With Advanced Solid Tumors
Actual Study Start Date : October 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: dose escalation then expansion

Dose escalation of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg. Six dose levels are planned: level 1,0.1 mg/kg; level 2,0.3 mg/kg; level 3, 1.0 mg/kg; level 4,3.0 mg/kg; level 5,10 mg/kg; level 6,20 mg/kg.

Dose Expansion - Up to 20 subjects will be enrolled and treated at the dose determined in Dose Escalation arm.

Drug: DS-8895a



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02004717


Locations
Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02004717     History of Changes
Other Study ID Numbers: DS8895-A-J101
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
advanced solid tumor
Phase 1
Oncology