A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

Zenyaku Kogyo

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: ZSTK474

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682473

ZSTK474-201

Details and patient eligibility

About

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

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Arm 1: 5/2 Dosing

Experimental group

Description:

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.

Treatment:

Drug: ZSTK474

Arm 2: 21/7 Dosing

Experimental group

Description:

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.

Treatment:

Drug: ZSTK474