Phase I Study of GDC-0032

Phase I Clinical Study of GDC-0032 in Patients With Advanced Solid Cancers or GDC-0032 in Combination With Fulvestrant in Patients With Hormone Receptor-positive Locally Advanced or Metastatic Breast Cancer

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222579

Enrollment

Registered

2014-08-11

Start date

2014-08-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage 1

Interventions

investigational material(s) Generic name etc : GDC-0032 INN of investigational material : taselisib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1) Safety Dose limiting toxicity, adverse event, laboratory test value, vital sign 2) Pharmacokinetics Assessment and observation	—

Secondary

Measure	Time frame
Anti tumor effect Assessment and observation	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026