Phase I Study of GDC-0068 as a Single Agent and in Combination with Other Anticancer Drugs in Patients with Advanced Solid Tumors.

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222858

Enrollment

Registered

2015-05-22

Start date

2015-05-22

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

Patients with Advanced Solid Tumors

Interventions

investigational material(s) Generic name etc : GDC-0068 INN of investigational material : ipatasertib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - ECOG PS of 0 or 1. - Adequate major organ function. - Stage I: Solid tumor for which standard therapy is ineffective or has not been established. - Stage II: Castration-resistant prostate cancer for which at least one type of hormone therapy is ineffective and the treatment with docetaxel is ineffective or not applicable.

Exclusion criteria

Exclusion criteria: - Taking oral medication is difficult. - Metastasis to the central nervous system requiring treatment or accompanied by symptoms. - Investigational products or the like with same mode of action were administered, and an adverse event with Grade>=3 severity occurred. - Concurrent or previous clinically critical disease. - Stage I: Women who are pregnant or lactating, or with a positive pregnancy test result.

Design outcomes

Primary

Measure	Time frame
Safety, tolerability, and pharmacokinetics Observations and tests	—

Secondary

Measure	Time frame
Anti-tumor effect Observations and tests	—

Outcome results

None listed

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