A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

July 3, 2017 updated by: Zenyaku Kogyo Co., Ltd.

A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa-city, Chiba, Japan
        • National Cancer Center Hospital East
    • Tokyo
      • Koto-ku, Tokyo, Japan
        • The Cancer Institute Hospital of JFCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese males or females >= 20 years old
  • Advanced (metastatic or unresectable) solid tumor
  • ECOG performance status score of 0 or 1 and expected survival >12 weeks
  • Recovered from hematological toxicities of prior cancer therapies

Exclusion Criteria:

  • Previous treatment with PI3K inhibitor
  • Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
  • Other investigational agent within previous 4 weeks
  • Participating in another clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: 5/2 Dosing
Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug.
Drug: ZSTK474
Two arms, each with serial cohorts receiving escalating doses.
Experimental: Arm 2: 21/7 Dosing
Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug.
Drug: ZSTK474
Two arms, each with serial cohorts receiving escalating doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with dose-limiting toxicities
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Cmax, tmax, t½, AUC)
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zenyaku Kogyo Co., Ltd.

Investigators

  • Principal Investigator: Toshihiko Doi, MD, PhD, National Cancer Center Hospital East
  • Principal Investigator: Shunji Takahashi, MD, The Cancer Institute Hospital of JFCR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2012

Primary Completion (Actual)

April 2, 2015

Study Completion (Actual)

April 20, 2015

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSTK474-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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