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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 1/Phase 2
20 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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


Open-label, uncontrolled, serial cohort, dose-escalation study


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose-limiting toxicities

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Toshihiko Doi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center Hospital East

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

ZSTK474-201

NCT ID:

NCT01682473

Start Date:

September 2012

Completion Date:

September 2013

Related Keywords:

  • Neoplasms
  • PI3K inhibitor
  • clinical trial
  • Neoplasms

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