Drug · Small Molecule
Apitolisib
CI-DRUG-00000077Explore in graph →NCIt C91731 CHEMBL1922094 CIViC Phase 2
Regulatory
Approvals (0)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
Data not yet available
No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.
What CancerIndex knows
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Phase2 | Phase 2 | 0 | 0 | 0 | 9 | 0 | — | — | 2009-03 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 2 | 0 | — | — | 2010-12 |
| Malignant Kidney Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — | — | 2011-10 |
| Malignant Prostate Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — |
Curated evidence
Clinical evidence (4)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 26787751
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| PIK3CA E542K1 | ||||||||
| Apitolisib | Head and Neck Squamous Cell Carcinoma | |||||||
Clinical trials
Trials with this intervention (9)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT01485861 | Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy | completed | Phase 1 / Phase 2 | 298 | Genentech, Inc.INDUSTRY | 9 | Sep 14, 2023 | clinicaltrials |
| NCT00854126 | A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma |