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

September 4, 2012
March 31, 2014
September 2012
March 2015   (final data collection date for primary outcome measure)
Number of participants with dose-limiting toxicities [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
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.
 
Recruiting
30
March 2015
March 2015   (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
Both
20 Years and older
No
Contact: Morihiro Kanno +81-3-3946-1113 ZSTK474@mail.zenyaku.co.jp
Japan
 
NCT01682473
ZSTK474-201
Yes
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.
March 2014

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