Dactolisib — drug · CancerIndex

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

Curated evidence below
Sources

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	Trials	Jurisdictions	First approval	First trial
All cancers	Phase2	Phase 2	16	—	—	Dec 21, 2006
Malignant Breast Neoplasm	Phase2	Phase 2	4	—	—	Dec 21, 2006
Malignant Uterine Corpus Neoplasm	Phase2	Phase 2	1	—	—	2012-03
Leukemia	Phase1	Phase 1	1	—

Curated evidence

Clinical evidence (53)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 51–53 of 53 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PIK3CA H1047R1
Dactolisib	Malignant Head and Neck Neoplasm

Clinical trials

Trials with this intervention (16)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–16 of 16 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01756118	A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia	completed	Phase 1	24	Goethe UniversityOTHER	1	Feb 16, 2023	clinicaltrials
NCT00620594	A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer	completed	Phase 1