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PHASE I STUDY OF GDC-0919 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTICANCER DRUGS IN PATIENTS WITH ADVANCED SOLID TUMORS

PHASE I STUDY OF GDC-0919 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-jRCT2080223275
Enrollment
42
Registered
2016-07-28
Start date
2016-07-28
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

Solid tumors

Interventions

investigational material(s) Generic name etc : GDC-0919/RG6078 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational m

Sponsors

CHUGAI PHARMACEUTICAL CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -ECOG Performance Status of 0 or 1 -Histologically or cytologically documented solid tumors -Evaluable lesion by image

Exclusion criteria

Exclusion criteria: -Inability to take oral drugs -Meningeal metastasis or metastasis to the central nervous system requiring treatment or accompanied by symptoms -History or complication of autoimmune disease

Design outcomes

Primary

MeasureTime frame
Safety, tolerability, and pharmacokinetics Observation/test

Secondary

MeasureTime frame
Anti-tumor activity Observation/test

Outcome results

None listed

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