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A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682473
First Posted: September 11, 2012
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zenyaku Kogyo Co., Ltd.
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

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

Primary Outcome Measures:
  • Number of participants with dose-limiting toxicities [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Pharmacokinetics (Cmax, tmax, t½, AUC) [ Time Frame: 28 days ]

Enrollment: 20
Actual Study Start Date: September 20, 2012
Study Completion Date: April 20, 2015
Primary Completion Date: April 2, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682473


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

Responsible Party: Zenyaku Kogyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01682473     History of Changes
Other Study ID Numbers: ZSTK474-201
First Submitted: September 4, 2012
First Posted: September 11, 2012
Last Update Posted: July 6, 2017
Last Verified: July 2017

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