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A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Zenyaku Kogyo Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zenyaku Kogyo Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01682473
First received: September 4, 2012
Last updated: January 15, 2015
Last verified: January 2015

September 4, 2012
January 15, 2015
September 2012
March 2016   (Final data collection date for primary outcome measure)
Number of participants with dose-limiting toxicities [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT01682473 on ClinicalTrials.gov Archive Site
Pharmacokinetics (Cmax, tmax, t½, AUC) [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
 
A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
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.
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).
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: ZSTK474
Two arms, each with serial cohorts receiving escalating doses.
  • 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.
    Intervention: Drug: ZSTK474
  • 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.
    Intervention: Drug: ZSTK474
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
March 2016
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01682473
ZSTK474-201
Yes
Not Provided
Not Provided
Not Provided
Zenyaku Kogyo Co., Ltd.
Zenyaku Kogyo Co., Ltd.
Not Provided
Principal Investigator: Toshihiko Doi, MD, PhD National Cancer Center Hospital East
Principal Investigator: Shunji Takahashi, MD The Cancer Institute Hospital of JFCR
Zenyaku Kogyo Co., Ltd.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP