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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02192567
Other study ID # DS5573-A-J101
Secondary ID
Status Terminated
Phase Phase 1
First received July 14, 2014
Last updated March 1, 2017
Start date September 2014
Est. completion date January 2017

Study information

Verified date March 2017
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date January 2017
Est. primary completion date January 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, 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Japan National Cancer Center Hospital Tokyo

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 subjects experiencing dose limiting toxicities Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events. Day 1 through Day 28
Primary Number of subjects experiencing adverse events Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events. Day 1 through 45 days after last dose
Primary Pharmacokinetic profile of DS-5573a 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. Cycle 1 - Day 1 through Cycle 8 - Day 1
Secondary Incidence of human anti-human antibodies (HAHA) against DS-5573a Incidence of human anti-human antibodies (HAHA) against DS-5573a. Cycle 1 - Day 1 through Cycle 1 - Day 15.
Secondary Assessment of tumor response to DS-5573a using RECIST ver1.1. Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation. week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90
Secondary Assessment of DS-5573a-related biomarkers in blood and tumor Assessment of DS-5573a-related biomarkers in blood and tumor. Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2
See also
  Status Clinical Trial Phase
Completed NCT02690337 - Study of DS-1123a in Advanced Solid Tumours Phase 1
Completed NCT01290471 - Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors Phase 1
Completed NCT02675491 - Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Phase 1