A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682473
• Other study ID #: ZSTK474-201
• Status: Completed
• Phase: Phase 1
• First received: September 4, 2012
• Last updated: July 3, 2017
• Start date: September 20, 2012
• Est. completion date: April 20, 2015

Study information

• Verified date: July 2017
• Source: Zenyaku Kogyo Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 20, 2015
• Est. primary completion date: April 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• ZSTK474
Two arms, each with serial cohorts receiving escalating doses.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital East	Kashiwa-city	Chiba
Japan	The Cancer Institute Hospital of JFCR	Koto-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Zenyaku Kogyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose-limiting toxicities		28 days
Secondary	Pharmacokinetics (Cmax, tmax, t½, AUC)		28 days