capivasertib
capivasertib: developed by 1 company · 20 clinical trials tracked · 1 FDA decision.
capivasertib evidence translation
What we can confirm
1 FDA record · 20 tracked trials
What it means
What to watch
Prepared research question
How could capivasertib → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 4 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| ASTRAZENECA PLC (AZN) Locally Advanced or Metastatic Breast Cancer; Locally Advanc… | Phase 3 |
Clinical Trials (20)showing 10 most recent
A Phase Ib/Phase II Trial With Capivasertib Plus Immunotherapy in Bladder Cancer
Primary endpoint: objective response rate (ORR)
A Phase II Trial to Improve Safety of Capivasertib for HR+/HER2- Metastatic Breast Cancer
Primary endpoint: Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants.
Primary endpoint: Area under concentration time curve from time 0 to infinity (AUCinf) of dextromethorphan
A Phase I, Single-dose, Non-randomized, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
Primary endpoint: Area under concentration time curve from zero to infinity (AUCinf)
An Interventional, Open-label, Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
Primary endpoint: Superiority* of TTNT1 in patients receiving capivasertib compared to an evidence-based "standard TTNT1 curve" for patients without capivasertib.
A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor
Primary endpoint: Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)
An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin (a BCRP, OATP1B1 and OATP1B3 Sensitive Substrate) in Healthy Participants
Primary endpoint: Area under concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With HR+ / HER2- Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
Primary endpoint: Time to next treatment (TTNT)
A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients
Primary endpoint: Time to first subsequent treatment (TFST) of PIK3CA/AKT1/PTEN-altered population in Cohort 1
Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss
Primary endpoint: Pathologic Complete Response or Minimal Residual Disease (MRD)
FDA Decisions1 records
Frequently asked questions
Who is developing capivasertib?
capivasertib is being developed by ASTRAZENECA PLC.
How many clinical trials involve capivasertib?
BioSniper tracks 20 clinical trials involving capivasertib.
What is capivasertib's latest FDA decision?
The most recent tracked FDA decision for capivasertib is Approval for 1 INDICATIONS AND USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the , dated November 16, 2023.