Trial | NCT01682473  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    zstk-474 ...

  • Study Participants

    20
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).
Study Started
Sep 20
2012
Primary Completion
Apr 02
2015
Study Completion
Apr 20
2015
Last Update
Jul 06
2017

Drug ZSTK474

Two arms, each with serial cohorts receiving escalating doses.

Arm 1: 5/2 Dosing Experimental

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.

Arm 2: 21/7 Dosing Experimental

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.

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
No Results Posted