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Completed

NCT Number: NCT01682473

A Study 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.

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZSTK474

Drug

Two arms, each with serial cohorts receiving escalating doses.

Primary outcomes

  1. Number of participants with dose-limiting toxicities

    Time frame: 28 days

Secondary outcomes

  1. Pharmacokinetics (Cmax, tmax, t½, AUC)

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Zenyaku Kogyo Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2012
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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