Study of DS-1123a in Advanced Solid Tumours

NCT02690337 | Completed Phase 1

• 1 other identifier: DS1123-A-J101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

Conditions

Advanced Solid Malignant Tumors

Keywords

Advanced solid malignant tumors; phase 1; oncology; refractory; no standard treatment

Outcome Measures

Primary Outcomes (11)

• Maximum concentration (Cmax)

  Cycles 1, 2 : Days 1,2, 4, 8, 15

• Number and severity of treatment emergent adverse events (TEAEs)

  Day 1 to Day 31

• Time of maximum concentration (Tmax)

  Cycles 1, 2: Days 1,2, 4, 8, 15

• Elimination rate constant (Kel)

  Cycles 1, 2: Days 1,2, 4, 8, 15

• area under the curve AUClast

  pharmacokinetics profile

  Cycles 1, 2: Days 1,2, 4, 8, 15

• Area under the curve (AUCtau)

  Cycles 1, 2: Days 1,2, 4, 8, 15

• Area under the curve (AUCinf)

  Cycles 1, 2: Days 1,2, 4, 8, 15

• Half-life (T1/2)

  Cycles 1, 2: Days 1,2, 4, 8, 15

• Drug clearance (CL)

  Cycles 1, 2: Days 1,2, 4, 8, 15

• Volume of distribution (Vz)

  Cycles 1, 2: Days 1,2, 4, 8, 15

• Mean residence time (MRTinf)

  Cycles 1, 2: Days 1,2, 4, 8, 15

Secondary Outcomes (2)

• DS-1123a antibody

  Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date

• Change in Cytokines expression

  Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2

Study Arms (1)

DS-1123

EXPERIMENTAL

This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg.

Drug: DS-1123

Interventions

DS-1123 DRUG

starting intravenous (IV) dose of 0.1 mg/kg.

DS-1123

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, 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.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Tokyo, 277-8577, Japan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

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: February 4, 2016
• First Posted: February 24, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (1)