Phase I Study of GDC-0032

Phase 1

• Conditions: Stage 1; Advanced solid cancers, Stage 2; Hormone receptor-positive locally advanced or metastatic breast cancer

• Registration Number: JPRN-jRCT2080222579
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Stage 1
Histologically or cytologically documented solid cancer.
Advanced or recurrent cancer for which standard treatment is ineffective or for which there is no established standard treatment.
Stage 2
Females who are histologically or cytologically documented breast cancer.
Hormone receptor positive locally advanced or metastatic breast cancer for which endocrine therapy is indicated.

Exclusion Criteria

Diabetes mellitus requiring drug treatment.
Central nervous system metastases that are symptomatic or require treatment.
Grade 3 or more adverse event during prior treatment with P13K inhibitor, or at high risk if again treated with P13K inhibitor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Safety<br>Dose limiting toxicity, adverse event, laboratory test value, vital sign<br>2) Pharmacokinetics<br><br>Assessment and observation

Secondary Outcome Measures

Name	Time	Method
Anti tumor effect<br><br>Assessment and observation