Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014