Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acalabrutinib · 2 trials · 14 indications
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.
Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
Number of participants with CTCAE Grade 5 (fatal) adverse events
Study drug-related AEs were those assessed by investigator as related to study treatment.
The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.
Grade 5 (fatal) AEs assessed by investigator as related to study treatment.
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher.
Grade 5 events were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.
Grade 5 AEs were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.
AEs that discontinuation of study treatment, or a reduction in dosage, or a delay (temporary withholding) in treatment.
An adverse event that resulted in the permanent discontinuation of study treatment in the study.
An adverse event that caused a temporary withholding of study treatment.
An adverse event that resulted in a reduction in the dosage of study treatment for that participant.
| Arm | Type | Description |
|---|---|---|
| Regimen 1 | EXPERIMENTAL | Drug: acalabrutinib monotherapy |
| Regimen 2 | EXPERIMENTAL | Drug: Combination of acalabrutinib and pembrolizumab |
| Acalabrutinib plus Pembrolizumab | EXPERIMENTAL | A nonrandomized study that will be conducted in 2 stages. In the first stage, (Safety), subjects will receive Acalabrutinib Dose A orally administered (PO) twice daily (BID) in combination with Pembrolizumab Dose B administered every 3 weeks (Q3W). The second stage was an expansion of Cohorts with the same dose regimen as the first stage. An additional expansion in subjects with Myelofibrosis was planned but not conducted. |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | - |
| acalabrutinib and pembrolizumab combination | DRUG | - |
| Pembrolizumab | DRUG | Intravenous Administered (IV) |
Inclusion Criteria: * Women ≥ 18 years of age. * Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. * Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane. * Platinu...
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Acalabrutinib is an investigational small molecule being studied for the treatment of ovarian cancer and follicular lymphoma (FL). It is a kinase inhibitor, specifically a -tinib class drug, and is being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development.
Acalabrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It works by targeting kinases, which are enzymes involved in cell signaling and growth. This mechanism is being explored in the context of oncology, particularly for ovarian cancer and follicular lymphoma.
Acalabrutinib is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating certain cancers, including ovarian cancer and follicular lymphoma.
Acalabrutinib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for the treatment of ovarian cancer and follicular lymphoma.
Acalabrutinib has been studied in two completed clinical trials. NCT02362035 was a Phase 1 trial combining Acalabrutinib with pembrolizumab for hematologic malignancies, including follicular lymphoma, with 161 participants. NCT02537444 was a Phase 2 trial of Acalabrutinib alone and with pembrolizumab in ovarian cancer, with 78 participants.
Yes, Acalabrutinib is also known as ACP-196. Clinical trial records refer to the drug as ACP-196, and it is being investigated under this name in studies for various cancers, including ovarian cancer and follicular lymphoma.