Akt-1 inhibitors(Serine/threonine-protein kinase AKT inhibitors), Akt-2 inhibitors(Serine/threonine-protein kinase AKT2 inhibitors), Akt-3 inhibitors(Serine/threonine-protein kinase AKT3 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesDigestive System Disorders+ [9]

Active Indication

ER-positive/HER2-negative Breast CancerHormone receptor positive HER2 negative breast cancerMetastatic castration-resistant prostate cancer+ [32]

Inactive Indication

Advanced cancerAdvanced Gastric AdenocarcinomaAdvanced gastric carcinoma+ [3]

Originator Organization

AstraZeneca PLC

Active Organization

AstraZeneca Investment (China) Co. Ltd.

AstraZeneca PLC

National Cancer Institute

+ [14]

Inactive Organization

Royal Marsden NHS Foundation Trust

Samsung Medical Center

Drug Highest PhaseApproved

First Approval Date

US (16 Nov 2023),

Hormone receptor positive HER2 negative breast cancer

RegulationPriority Review (US)

Structure

Molecular FormulaC21H25ClN6O2

InChIKeyJDUBGYFRJFOXQC-KRWDZBQOSA-N

CAS Registry1143532-39-1

Clinical Trials associated with Capivasertib

NCT05593497 / RecruitingPhase 2

Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss

The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.

Start Date31 May 2024

Sponsor / Collaborator

VA Office of Research and Development

CTR20223181 / RecruitingPhase 3

一项评估Capivasertib + 多西他赛对比安慰剂 + 多西他赛治疗转移性去势抵抗性前列腺癌(mCRPC)患者的有效性和安全性的III期、双盲、随机、安慰剂对照研究

[Translation] A Phase III, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of capivasertib + docetaxel versus placebo + docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC)

主要目的：通过评估mCRPC患者的总生存期(OS)，证明Capivasertib + 多西他赛优于安慰剂 + 多西他赛。次要目的：1.通过评估mCRPC患者的rPFS，证明Capivasertib + 多西他赛优于安慰剂 + 多西他赛。 2.通过评估mCRPC患者的TTPP，证明Capivasertib + 多西他赛优于安慰剂 + 多西他赛。 3.通过评估mCRPC患者至SSRE的时间，证明Capivasertib + 多西他赛优于安慰剂 + 多西他赛。 4.通过评估mCRPC患者至TTDUS，证明Capivasertib + 多西他赛相对于安慰剂 + 多西他赛的有效性。 5.通过评估mCRPC患者的至TTDPF，证明Capivasertib + 多西他赛相对于安慰剂 + 多西他赛的有效性。 6.通过使用BPI-SF评估mCRPC患者的HrQoL，证明Capivasertib + 多西他赛相对于安慰剂 + 多西他赛的有效性。 7.评价Capivasertib联合多西他赛的PK。

[Translation]

Primary objective: To demonstrate that Capivasertib + docetaxel is superior to placebo + docetaxel by evaluating the overall survival (OS) of mCRPC patients. Secondary objectives: 1. To demonstrate that Capivasertib + docetaxel is superior to placebo + docetaxel by evaluating the rPFS of mCRPC patients. 2. To demonstrate that Capivasertib + docetaxel is superior to placebo + docetaxel by evaluating the TTPP of mCRPC patients. 3. To demonstrate that Capivasertib + docetaxel is superior to placebo + docetaxel by evaluating the time to SSRE of mCRPC patients. 4. To demonstrate the effectiveness of Capivasertib + docetaxel relative to placebo + docetaxel by evaluating the time to TTDUS of mCRPC patients. 5. To demonstrate the effectiveness of Capivasertib + docetaxel relative to placebo + docetaxel by evaluating the time to TTDPF of mCRPC patients. 6. To demonstrate the efficacy of Capivasertib + docetaxel compared with placebo + docetaxel by evaluating HrQoL in mCRPC patients using BPI-SF. 7. To evaluate the PK of Capivasertib combined with docetaxel.

Start Date08 Feb 2023

Sponsor / Collaborator

AstraZeneca AB

[+1]

NCT05563220 / RecruitingPhase 1/2

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

Start Date24 Jan 2023

Sponsor / Collaborator

Stemline Therapeutics, Inc.

100 Clinical Results associated with Capivasertib

100 Translational Medicine associated with Capivasertib

100 Patents (Medical) associated with Capivasertib

164

Literatures (Medical) associated with Capivasertib

01 Feb 2024·Pharmacological research

Properties of FDA-approved small molecule protein kinase inhibitors: A 2024 update

Review

Author: Roskoski, Robert

Owing to the dysregulation of protein kinase activity in many diseases including cancer, this enzyme family has become one of the most important drug targets in the 21st century. There are 80 FDA-approved therapeutic agents that target about two dozen different protein kinases and seven of these drugs were approved in 2023. Of the approved drugs, thirteen target protein-serine/threonine protein kinases, four are directed against dual specificity protein kinases (MEK1/2), twenty block nonreceptor protein-tyrosine kinases, and 43 inhibit receptor protein-tyrosine kinases. The data indicate that 69 of these drugs are prescribed for the treatment of neoplasms. Six drugs (abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, upadacitinib) are used for the treatment of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis). Of the 80 approved drugs, nearly two dozen are used in the treatment of multiple diseases. The following seven drugs received FDA approval in 2023: capivasertib (HER2-positive breast cancer), fruquintinib (metastatic colorectal cancer), momelotinib (myelofibrosis), pirtobrutinib (mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma), quizartinib (Flt3-mutant acute myelogenous leukemia), repotrectinib (ROS1-positive lung cancer), and ritlecitinib (alopecia areata). All of the FDA-approved drugs are orally effective with the exception of netarsudil, temsirolimus, and trilaciclib. This review summarizes the physicochemical properties of all 80 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, polar surface area, potency, solubility, lipophilic efficiency, and ligand efficiency.

01 Jan 2024·European journal of pharmacology

The role and mechanism of AZD5363 anti-leukemia activity in T-cell acute lymphoblastic leukemia

Article

Author: Luo, Danqing ; Wang, Jianhua ; Shi, Xiaodong ; Liu, Rong ; Shi, Lixiao ; Yue, Huixuan ; Guo, Jin ; Li, Shen

BACKGROUND:

T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive and heterogeneous hematologic malignancy. Chemotherapy resistance and refractory relapses are the most important challenges in T-ALL. PI3K/Akt/mTOR pathway has been implicated in regulating cell survival, T-ALL development and resistance to chemotherapy. We explored the effects of AZD5363 (a potent pan-Akt inhibitor) alone and in combination with autophagy inhibitor hydroxycholoroquine sulfate (HCQ) in cultured CCRF-CEM, Jurkat and PF382 cells and a T-ALL xenograft mouse model.

METHODS:

A xenograft mouse model was used to investigate the effect of AZD5363 on T-ALL progression. MTT assay, flow cytometry, siRNA, transmission electron microscopy and western blotting were performed in cultured CCRF-CEM, Jurkat and PF382 cells. The interaction between AZD5363 and HCQ was explored by molecular docking.

RESULTS:

AZD5363 delayed T-ALL progression and increased the expression of cleaved caspase-3 and LC3B-II in mice. AZD5363 decreased cells viability by arresting cell cycle in the G1 phase and inducing apoptosis, and, significantly increased the number of autophagosomes (p < 0.01). The increased expression of cleaved caspase-3 and LC3B-II, and phosphorylation of Akt and mTOR were significantly, inhibited by AZD5363. HCQ blocked AZD5363-induced autophagy and enhanced AZD5363-induced cell death (p < 0.01).

CONCLUSIONS:

AZD5363 suppressed T-ALL progression and its anti-leukemia activity was enhanced by HCQ in T-ALL cells, which might provide a potential therapeutic strategy for human T-ALL.

01 Jan 2024·Advanced science (Weinheim, Baden-Wurttemberg, Germany)

Enzyme‐Responsive Branched Glycopolymer‐Based Nanoassembly for Co‐Delivery of Paclitaxel and Akt Inhibitor toward Synergistic Therapy of Gastric Cancer

Article

Author: Gong, Qiyong ; Shi, Zhaochen ; Yang, Kun ; Li, Zhiqian ; Hu, Jiankun ; Cai, Hao ; Zheng, Xiuli ; Gu, Zhongwei ; Song, Xiaohai ; Luo, Kui

Abstract:

Combined chemotherapy and targeted therapy holds immense potential in the management of advanced gastric cancer (GC). GC tissues exhibit an elevated expression level of protein kinase B (AKT), which contributes to disease progression and poor chemotherapeutic responsiveness. Inhibition of AKT expression through an AKT inhibitor, capivasertib (CAP), to enhance cytotoxicity of paclitaxel (PTX) toward GC cells is demonstrated in this study. A cathepsin B‐responsive polymeric nanoparticle prodrug system is employed for co‐delivery of PTX and CAP, resulting in a polymeric nano‐drug BPGP@CAP. The release of PTX and CAP is triggered in an environment with overexpressed cathepsin B upon lysosomal uptake of BPGP@CAP. A synergistic therapeutic effect of PTX and CAP on killing GC cells is confirmed by in vitro and in vivo experiments. Mechanistic investigations suggested that CAP may inhibit AKT expression, leading to suppression of the phosphoinositide 3‐kinase (PI3K)/AKT signaling pathway. Encouragingly, CAP can synergize with PTX to exert potent antitumor effects against GC after they are co‐delivered via a polymeric drug delivery system, and this delivery system helped reduce their toxic side effects, which provides an effective therapeutic strategy for treating GC.

News (Medical) associated with Capivasertib

20 Jun 2024

·pipelinereview.com

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

First and only AKT inhibitor approved in the EU for breast cancer patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN) Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population LONDON, UK I June 20, 2024 I AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the CAPItello-291 Phase III trial published in The New England Journal of Medicine . 1 In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex in combination with placebo in patients with tumours harbouring PI3K, AKT or PTEN alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months). 1 In Europe, breast cancer remains the leading cause of cancer death, with more than 140,000 deaths in 2022 and more than 550,000 patients diagnosed in the same year. 2 Hormone receptor (HR)-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative. 3 More than 97% of HR-positive breast cancer tumours are ER-positive. 4,5 Collectively, mutations in PIK3CA, AKT1 and alterations in PTENoccur frequently, affecting approximately 50% of patients with advanced HR-positive breast cancer. 6-8 Mafalda Oliveira, MD, PhD, Vall d’Hebron University Hospital, and Senior Clinical Investigator of the Vall d’Hebron Institute of Oncology’s Breast Cancer Group in Barcelona, Spain, said: “Patients with advanced ER-positive breast cancer typically experience tumour progression or resistance with widely used endocrine-based treatment regimens, and there is an urgent need to provide them more time with their disease under control. Today’s approval is welcome news for approximately half of ER-positive breast cancer patients in Europe who have tumours with these biomarkers, and it is important for clinicians to test and identify eligible patients who may be able to benefit from this combination.” Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “ Truqap is now the first and only AKT inhibitor approved in the European Union for patients with ER-positive breast cancer who have tumours harbouring these specific biomarkers. Breast cancer continues to be the leading cause of cancer-related death in Europe, and today’s news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies.” In the CAPItello-291 trial, the safety profile of Truqap plus Faslodex was similar to that observed in previous trials evaluating this combination. 1 Regulatory applications are currently under review in China and several other countries. Similar indications for Truqap in combination with Faslodex are already approved in the US , Japan and several other countries based on the CAPItello-291 trial. Financial considerations Following this approval in the EU, Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the EU as well as royalties on future sales in line with the agreement between the two companies. Notes HR-positive breast cancer The growth of HR-positive breast cancer cells is often driven by estrogen receptors, and endocrine therapies that target ER-driven disease are widely used as 1st-line treatment in the advanced setting, and often paired with CDK4/6 inhibitors. 9-11 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 10 Once this occurs, treatment options are limited– with chemotherapy being the current standard of care – and survival rates are low with approximately 35% of patients anticipated to live beyond five years after diagnosis. 3,10,12 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. CAPItello-291 CAPItello-291 is a Phase III, double-blind, randomised trial evaluating the efficacy of Truqap in combination with Faslodex versus placebo plus Faslodex for the treatment of locally advanced (inoperable) or metastatic HR-positive (ER-positive and ER-positive, progesterone receptor-positive), HER2-low or negative (immunohistochemistry (IHC) 0 or 1+, or IHC 2+/in-situ hybridisation (ISH)-negative) breast cancer. The global trial enrolled 708 adult patients with histologically confirmed HR-positive, HER2-low or negative breast cancer whose disease has recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The trial has dual primary endpoints of PFS in the overall patient population and in a population of patients whose tumours have qualifying alterations in the PI3K/AKT pathway (PIK3CA, AKT1 or PTEN genes). In the trial, approximately 40% of tumours had these alterations and approximately 70% of patients received a prior CDK4/6 inhibitor. Truqap Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition. Truqap is approved in the US, EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results. Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments. Truqap was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited). Faslodex Faslodex is an endocrine therapy indicated for the treatment of ER-positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on anti-estrogen therapy. In the US, EU and Japan , Faslodex is also approved in combination with CDK4/6 inhibitors for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine . Faslodex represents a hormonal treatment approach that helps to slow tumour growth by blocking and degrading the estrogen receptor – a key driver of disease progression. Faslodex is approved as monotherapy or in combination with medicines from various drug classes including CDK4/6, PI3K and AKT inhibitors for the treatment of patients with HR-positive advanced breast cancer and is being evaluated in combination with medicines from other drug classes. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap , and next-generation SERD and potential new medicine camizestrant. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is evaluating the potential of datopotamab deruxtecan alone and in combination with immunotherapy Imfinzi (durvalumab), and Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu . AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca References SOURCE: AstraZeneca

Phase 3Drug ApprovalClinical ResultImmunotherapy

20 Jun 2024

·firstwordpharma.com

AstraZeneca gets EU nod for AKT inhibitor Truqap in breast cancer

AstraZeneca’s Truqap (capivasertib) became the first AKT inhibitor approved in the EU for breast cancer patients with one or more PIK3CA/AKT1/PTEN-alterations. Dave Fredrickson, executive vice president of the company’s oncology business unit, noted Thursday that the authorisation “represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies.”Specifically, Truqap is indicated in combination with Faslodex (fulvestrant) for the treatment of adults with oestrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. The drug already has similar approvals in the US and Japan.Clearance from the European Commission was based on results from the Phase III CAPItello-291 trial in which the combination of Truqap and Faslodex reduced the risk of disease progression or death by 50% versus Faslodex in combination with placebo in patients with tumours harbouring PI3K/AKT/PTEN-alterations. A regulatory application based on the data is also under review in China.Truqap, which was discovered under a collaboration with Otsuka’s Astex Therapeutics unit, is also being studied in prostate cancer. However, efforts in triple-negative breast cancer were recently dealt a blow with the failure of the Phase III CAPItello-290 trial.

Phase 3Drug ApprovalClinical ResultClinical Trial Termination

20 Jun 2024

·pmlive.com

AstraZeneca’s Truqap plus Faslodex granted EC approval to treat advanced breast cancer

AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) and its endocrine therapy Faslodex (fulvestrant) have been approved by the European Commission (EC) as a combination treatment for a subset of adults with advanced breast cancer. Patients eligible for the combination will have oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with at least one PIK3CA, AKT1 or PTEN alteration and will have experienced disease recurrence or progression on or after an endocrine-based regimen. The EC’s decision follows a recent recommendation from the European Medicines Agency’s and is supported by positive results from the late-stage CAPItello-291 trial, in which Truqap plus Faslodex reduced the risk of disease progression or death by 50% compared with Faslodex alone in patients with tumours harbouring PI3K, AKT pathway or PTEN alterations. Breast cancer remains the leading cause of cancer death in Europe, where more than 550,000 new cases of the disease were diagnosed in 2022. The growth of HR-positive breast cancer progression is often driven by ERs, and endocrine therapies that target ER-driven disease are widely used as a first-line treatment in the advanced setting and often paired with CDK4/6 inhibitors. However, resistance to these therapies develops in many patients with advanced disease, at which point treatment options are limited and survival rates are low. Dave Fredrickson, executive vice president, oncology business unit, AZ, outlined that Truqap is now the first and only AKT inhibitor approved in the EU for patients with ER-positive breast cancer who have tumours harbouring PIK3CA, AKT1 or PTEN. “Breast cancer continues to be the leading cause of cancer-related death in Europe, and [this] news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies,” he said. The authorisation comes just days after AZ’s Imfinzi (durvalumab) was approved by the US Food and Drug Administration as part of a combination therapy for a subset of endometrial cancer patients. Imfinzi plus carboplatin and paclitaxel, followed by Imfinzi monotherapy, is now authorised to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.

Drug ApprovalClinical Result

100 Deals associated with Capivasertib

External Link

KEGG	Wiki	ATC	Drug Bank
D11371	-	-	DB12218

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	EU	AstraZeneca AB	20 Jun 2024
ER-positive/HER2-negative Breast Cancer	IS	AstraZeneca AB	20 Jun 2024
ER-positive/HER2-negative Breast Cancer	LI	AstraZeneca AB	20 Jun 2024
ER-positive/HER2-negative Breast Cancer	NO	AstraZeneca AB	20 Jun 2024
Hormone receptor positive HER2 negative breast cancer	US	AstraZeneca Pharmaceuticals LP	16 Nov 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 3	US	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	CN	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	JP	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	AU	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	BE	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	BR	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	CA	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	CL	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	CZ	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	FR	AstraZeneca PLC	25 Mar 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05008055 (CAPITAL, CTgov)	Phase 2	B-cell lymphoma refractory	30	Capivasertib (Relapsed or Refractory Follicular Lymphoma (R/R FL): Capivasertib Monotherapy)	isxchgesqs(ccmqhigcdu) = wbasviwhjj nogmqqicvh (lfswxietjf, qyxzmxlisp - alzbbawwbb) View more	-	19 Jun 2024
				Capivasertib (Relapsed or Refractory Marginal Zone Lymphoma (R/R MZL): Capivasertib Monotherapy)	isxchgesqs(ccmqhigcdu) = pyoqrxdxnf nogmqqicvh (lfswxietjf, wpxlnatcgm - vyncagocmm) View more
NCT03997123 (CAPItello-290, Company_Website) Manual	Phase 3	Advanced Triple-Negative Breast Carcinoma PIK3CA \| AKT1 \| PTEN	923	Truqap (capivasertib) in combination with paclitaxel	srufhvgzii(tjmvlgsdfb) = did not meet the dual primary endpoints of improvement in overall survival (OS) tqxdsealon (ctkgqkhvpf ) Not Met View more	Negative	18 Jun 2024
				paclitaxel in combination with placebo
CAPItello-291 (SABCS2023)	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2− defined as IHC 0, or 1+ or IHC2+/ISH-	708	Capivasertib + Fulvestrant	ytxyhckpqn(zafigrhkpr) = Diarrhea with C-F was generally manageable, and discontinuations due to diarrhea were low (2.0%; n=7/355) iumzqjbcdf (vxsmqvbaib ) View more	Positive	05 Dec 2023
				Placebo + Fulvestrant
CAPItello-291 (ESMO_ASIA2023)	Phase 3	Hormone receptor positive HER2 negative breast cancer PIK3CA \| AKT1 \| PTEN	134	Capivasertib + fulvestrant	szwtqldwcn(hxvapigsmx) = sgwhculrzw yluhqngqwa (qrakboppls )	Positive	02 Dec 2023
				Placebo + fulvestrant	szwtqldwcn(hxvapigsmx) = iszjszbaas yluhqngqwa (qrakboppls )
NCT04305496 (CAPItello-291, FDA) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive	708	TRUQAP+fulvestrant (PIK3CA/AKT1/PTEN-Altered Tumors)	ysaqxtfyqf(lwjyyqgpmg) = adqauldyxl muqaujqehu (yzzvqmoltx ) View more	Positive	16 Nov 2023
				placebo+fulvestrant (PIK3CA/AKT1/PTEN-Altered Tumors)	ysaqxtfyqf(lwjyyqgpmg) = volxaxckpw muqaujqehu (yzzvqmoltx ) View more
NCT05008055 (CAPITAL, EHA2023)	Phase 2	B-cell lymphoma refractory	15	Capivasertib 480 mg	ovsgqfswlh(jcchawdszd) = gysxbcengp dozfygktht (iuxgymnfea )	-	08 Jun 2023
NCT04305496 (CAPItello-291, Pubmed)	Phase 3	Hormone receptor positive breast cancer	708	Capivasertib plus fulvestrant	pauhqwsqwg(gvyvyuylyv) = Adverse events leading to discontinuation were reported in 13.0% of the patients receiving capivasertib and in 2.3% of those receiving placebo izwvguyofj (uklhbzgoox ) View more	Positive	01 Jun 2023
				Placebo plus fulvestrant
NCT04305496 (CAPItello-291, ASCO2023) Manual	Phase 3	Advanced breast cancer HR Positive \| HER2 Positive	705	Capivasertib 400 mg+ Fulvestrant 500 mg	ylvfgsydkl(lyaoxncaki) = Common AEs were diarrhea, rash, and hyperglycemia; maximum AE grade was mostly 1/2 and led to low rates of discontinuation. In the C+F arm, medications for the management of AEs were used in 151/257 pts (59%) with diarrhea (mostly loperamide; n=135), 109/135 pts (81%) with rash (mostly antihistamines; n=75/topical corticosteroids; n=64), and 28/60 pts (47%) with hyperglycemia (mostly metformin; n=18). hepadhuygu (bgpigeuqik )	Positive	31 May 2023
				Placebo + Fulvestrant 500 mg
NCT03660826 (NRG-GY012, ASCO2023)	Phase 2	Metastatic endometrial cancer Maintenance	-	Cediranib PO 30 mg Daily	bznimsnece(brigrzqftk) = axxibcrrji slrbvddcqm (mgapiwkeay )	-	31 May 2023
NCT04305496 (CAPItello-291, ESMO_BC2023)	Phase 3	-	708	Capivasertib-fulvestrant	dismbyrbji(kwiojkgray): HR = 0.6 (95% CI, 0.51 - 0.71)	Positive	11 May 2023
				Placebo-fulvestrant

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