A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

This study is currently recruiting participants.
Verified March 2014 by Zenyaku Kogyo Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Zenyaku Kogyo Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01682473
First received: September 4, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Neoplasms
Drug: ZSTK474
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zenyaku Kogyo Co., Ltd.:

Primary Outcome Measures:
  • Number of participants with dose-limiting toxicities [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (Cmax, tmax, t½, AUC) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682473

Contacts
Contact: Morihiro Kanno +81-3-3946-1113 ZSTK474@mail.zenyaku.co.jp

Locations
Japan
National Cancer Center Hospital East Recruiting
Kashiwa-city, Chiba, Japan
Principal Investigator: Toshihiko Doi, MD PhD         
The Cancer Institute Hospital of JFCR Recruiting
Koto-ku, Tokyo, Japan
Principal Investigator: Shunji Takahashi, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Zenyaku Kogyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01682473     History of Changes
Other Study ID Numbers: ZSTK474-201
Study First Received: September 4, 2012
Last Updated: March 31, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Zenyaku Kogyo Co., Ltd.:
PI3K inhibitor
clinical trial

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014