Open Label Study of DS-5573a

NCT02192567 | Terminated Phase 1 DMC

• 1 other identifier: DS5573-A-J101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Malignant Tumors

Keywords

Advanced solid malignant tumor; phase 1; oncology

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Incidence of human anti-human antibodies (HAHA) against DS-5573a

  Cycle 1 - Day 1 through Cycle 1 - Day 15.

• Assessment of tumor response to DS-5573a using RECIST ver1.1.

  week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90

• Assessment of DS-5573a-related biomarkers in blood and tumor

  Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2

Study Arms (1)

DS-5573a does escalation (step 1) and expansion (step 2)

EXPERIMENTAL

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

Interventions

DS-5573a DRUG

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.

DS-5573a does escalation (step 1) and expansion (step 2)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

DS-5573a

Study Officials

• Kenji Tamura, MD

  National Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 17, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

JP (1)