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Open Label Study of DS-5573a

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ClinicalTrials.gov Identifier: NCT02192567
Recruitment Status : Terminated (Business decision)
First Posted : July 17, 2014
Last Update Posted : March 3, 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, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Malignant Tumors Drug: DS-5573a Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors
Study Start Date : September 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: DS-5573a does escalation (step 1) and expansion (step 2)

Step 1 of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg.

Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg Step 2: 30 subjects will be enrolled and treated at the dose determined in Step 1.

Drug: DS-5573a

Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg.

Step 2: 30 subjects will use the dose determined in Step 1.




Primary Outcome Measures :
  1. Number of subjects experiencing dose limiting toxicities [ Time Frame: Day 1 through Day 28 ]
    Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.

  2. Number of subjects experiencing adverse events [ Time Frame: Day 1 through 45 days after last dose ]
    Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.

  3. Pharmacokinetic profile of DS-5573a [ Time Frame: Cycle 1 - Day 1 through Cycle 8 - Day 1 ]
    Pharmacokinetic profile of DS-5573a. [Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors.


Secondary Outcome Measures :
  1. Incidence of human anti-human antibodies (HAHA) against DS-5573a [ Time Frame: Cycle 1 - Day 1 through Cycle 1 - Day 15. ]
    Incidence of human anti-human antibodies (HAHA) against DS-5573a.

  2. Assessment of tumor response to DS-5573a using RECIST ver1.1. [ Time Frame: week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 ]
    Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.

  3. Assessment of DS-5573a-related biomarkers in blood and tumor [ Time Frame: Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2 ]
    Assessment of DS-5573a-related biomarkers in blood and tumor.



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment.

  • 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): NCT02192567


Locations
Japan
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Kenji Tamura, MD National Cancer Center Hospital

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02192567     History of Changes
Other Study ID Numbers: DS5573-A-J101
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Advanced solid malignant tumor
phase 1
oncology

Additional relevant MeSH terms:
Neoplasms