Copanlisib — 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	Active	Phase 3	Trials	Jurisdictions	First approval	First trial
All cancers	Phase3	Phase 3	15	3	70	—	—	Nov 19, 2009
Non-Hodgkin Lymphoma	Phase3	Phase 3	8	3	32	—	—	Nov 19, 2012
Malignant Breast Neoplasm	Phase2	Phase 2	3	0	10	—	—	Aug 17, 2015
Multiple Myeloma	Phase2	Phase 2	3	0	4	—

Curated evidence

Clinical evidence (2)

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

civicCuratedShowing 1–2 of 2 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
AURKB Overexpression1
Alisertib + Barasertib

Clinical trials

Trials with this intervention (72)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 72 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
NCT03939897	Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer	active not recruiting	Phase 1	24	National Cancer Institute (NCI)NIH	1	Sep 8, 2026	clinicaltrials
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)