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Last Updated: March 18, 2025

CLINICAL TRIALS PROFILE FOR CAPIVASERTIB


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All Clinical Trials for capivasertib

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02208375 ↗ mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Active, not recruiting AstraZeneca Phase 1/Phase 2 2014-11-11 This phase Ib/II trial studies the side effects and best dose of olaparib and vistusertib (AZD2014) or olaparib and capivasertib (AZD5363) when given together in treating patients with endometrial, triple negative breast cancer, ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Olaparib, vistusertib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02208375 ↗ mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Active, not recruiting National Cancer Institute (NCI) Phase 1/Phase 2 2014-11-11 This phase Ib/II trial studies the side effects and best dose of olaparib and vistusertib (AZD2014) or olaparib and capivasertib (AZD5363) when given together in treating patients with endometrial, triple negative breast cancer, ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Olaparib, vistusertib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02208375 ↗ mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Active, not recruiting M.D. Anderson Cancer Center Phase 1/Phase 2 2014-11-11 This phase Ib/II trial studies the side effects and best dose of olaparib and vistusertib (AZD2014) or olaparib and capivasertib (AZD5363) when given together in treating patients with endometrial, triple negative breast cancer, ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Olaparib, vistusertib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02423603 ↗ PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer Active, not recruiting AstraZeneca Phase 2 2014-05-01 PAKT was an investigator-led, placebo-controlled, randomized phase II trial performed in 42 academic medical centers in the United Kindom, South Korea, France, Hungary, Romania, and Georgia. Patients were randomly assigned (1:1) to receive paclitaxel plus capivasertib or paclitaxel plus placebo. Stratification was by number of metastatic sites (< 3 v ≥ 3) and interval from the end of prior adjuvant or neoadjuvant chemotherapy (≤ 12 v > 12 months v no prior chemotherapy). Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle. Capivasertib 400 mg or placebo was administered orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle. All treatments were continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of adverse events (AEs), capivasertib or placebo could be reduced to 320 mg twice per day and subsequently to 240 mg twice per day. Capivasertib or placebo could be interrupted for up to 4 weeks for toxicity. Tumor assessments included computed tomography scanning or magnetic resonance imaging of the chest, abdomen, and pelvis at baseline, every 8 weeks during treatment, and at progression. Patients who discontinued treatment for any reason other than progression were required to follow the same schedule of assessments until progression, initiation of another treatment, death, or withdrawal of consent.
NCT02423603 ↗ PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer Active, not recruiting Cancer Research UK Phase 2 2014-05-01 PAKT was an investigator-led, placebo-controlled, randomized phase II trial performed in 42 academic medical centers in the United Kindom, South Korea, France, Hungary, Romania, and Georgia. Patients were randomly assigned (1:1) to receive paclitaxel plus capivasertib or paclitaxel plus placebo. Stratification was by number of metastatic sites (< 3 v ≥ 3) and interval from the end of prior adjuvant or neoadjuvant chemotherapy (≤ 12 v > 12 months v no prior chemotherapy). Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle. Capivasertib 400 mg or placebo was administered orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle. All treatments were continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of adverse events (AEs), capivasertib or placebo could be reduced to 320 mg twice per day and subsequently to 240 mg twice per day. Capivasertib or placebo could be interrupted for up to 4 weeks for toxicity. Tumor assessments included computed tomography scanning or magnetic resonance imaging of the chest, abdomen, and pelvis at baseline, every 8 weeks during treatment, and at progression. Patients who discontinued treatment for any reason other than progression were required to follow the same schedule of assessments until progression, initiation of another treatment, death, or withdrawal of consent.
NCT02423603 ↗ PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer Active, not recruiting Queen Mary University of London Phase 2 2014-05-01 PAKT was an investigator-led, placebo-controlled, randomized phase II trial performed in 42 academic medical centers in the United Kindom, South Korea, France, Hungary, Romania, and Georgia. Patients were randomly assigned (1:1) to receive paclitaxel plus capivasertib or paclitaxel plus placebo. Stratification was by number of metastatic sites (< 3 v ≥ 3) and interval from the end of prior adjuvant or neoadjuvant chemotherapy (≤ 12 v > 12 months v no prior chemotherapy). Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle. Capivasertib 400 mg or placebo was administered orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle. All treatments were continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of adverse events (AEs), capivasertib or placebo could be reduced to 320 mg twice per day and subsequently to 240 mg twice per day. Capivasertib or placebo could be interrupted for up to 4 weeks for toxicity. Tumor assessments included computed tomography scanning or magnetic resonance imaging of the chest, abdomen, and pelvis at baseline, every 8 weeks during treatment, and at progression. Patients who discontinued treatment for any reason other than progression were required to follow the same schedule of assessments until progression, initiation of another treatment, death, or withdrawal of consent.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for capivasertib

Condition Name

3222000.511.522.53Metastatic Breast CancerRecurrent Uterine Corpus CancerLocally Advanced (Inoperable) or Metastatic Breast CancerRecurrent Uterine Corpus Carcinoma[disabled in preview]
Condition Name for capivasertib
Intervention Trials
Metastatic Breast Cancer 3
Recurrent Uterine Corpus Cancer 2
Locally Advanced (Inoperable) or Metastatic Breast Cancer 2
Recurrent Uterine Corpus Carcinoma 2
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Condition MeSH

105430-101234567891011Breast NeoplasmsProstatic NeoplasmsNeoplasmsLymphoma[disabled in preview]
Condition MeSH for capivasertib
Intervention Trials
Breast Neoplasms 10
Prostatic Neoplasms 5
Neoplasms 4
Lymphoma 3
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Clinical Trial Locations for capivasertib

Trials by Country

+
Trials by Country for capivasertib
Location Trials
United States 263
Canada 21
United Kingdom 7
France 7
Korea, Republic of 7
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Trials by US State

+
Trials by US State for capivasertib
Location Trials
Texas 13
California 11
Tennessee 9
Pennsylvania 9
New York 9
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Clinical Trial Progress for capivasertib

Clinical Trial Phase

21.7%34.8%8.7%34.8%02345678Phase 3Phase 2Phase 1/Phase 2[disabled in preview]
Clinical Trial Phase for capivasertib
Clinical Trial Phase Trials
Phase 3 5
Phase 2 8
Phase 1/Phase 2 2
[disabled in preview] 8
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Clinical Trial Status

65.2%13.0%13.0%8.7%0246810121416RecruitingActive, not recruitingCompleted[disabled in preview]
Clinical Trial Status for capivasertib
Clinical Trial Phase Trials
Recruiting 15
Active, not recruiting 3
Completed 3
[disabled in preview] 2
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Clinical Trial Sponsors for capivasertib

Sponsor Name

trials024681012141618AstraZenecaNational Cancer Institute (NCI)Parexel[disabled in preview]
Sponsor Name for capivasertib
Sponsor Trials
AstraZeneca 17
National Cancer Institute (NCI) 5
Parexel 4
[disabled in preview] 3
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Sponsor Type

63.2%21.1%13.2%002468101214161820222426IndustryOtherNIH[disabled in preview]
Sponsor Type for capivasertib
Sponsor Trials
Industry 24
Other 8
NIH 5
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Capivasertib: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Capivasertib

Capivasertib, also known as AZD5363, is a highly potent pan-Akt kinase inhibitor that has been gaining significant attention in the oncology field. It targets the AKT pathway, which is crucial for the survival, growth, and proliferation of cancer cells. Here, we will delve into the latest clinical trial updates, market analysis, and projections for this promising drug.

Mechanism of Action

Capivasertib inhibits the AKT kinase, which is involved in several hallmark characteristics of cancer cells, including cell survival, proliferation, migration, and angiogenesis. By preventing substrate phosphorylation by AKT, capivasertib down-regulates the phosphorylation levels of AKT downstream substrates such as GSK3B and PRAS40 in many cancer cells[5].

Clinical Trials Update

CAPItello-290 Trial

The CAPItello-290 trial investigated the combination of capivasertib and paclitaxel in patients with advanced triple-negative breast cancer (TNBC). Unfortunately, this trial did not meet its primary endpoint of overall survival, despite previous phase 2 trials showing promising results in terms of progression-free survival and overall survival[1].

CAPItello-291 Trial

The CAPItello-291 trial was a phase III clinical trial that evaluated the combination of capivasertib and fulvestrant in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. This trial demonstrated a statistically significant improvement in progression-free survival compared to the placebo plus fulvestrant group. The success of this trial led to the FDA approval of capivasertib for this patient population[3][4].

CAPItello-292 Trial

Currently ongoing, the CAPItello-292 trial is a phase III clinical trial assessing the tri-combination of capivasertib, fulvestrant, and a CDK4/6 inhibitor in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. This trial aims to evaluate the efficacy and safety of this combination in the first-line treatment setting[2][5].

Other Ongoing Trials

Capivasertib is also being evaluated in several other clinical trials, including the CAPItello-280 and CAPItello-281 trials in patients with prostate cancer. These trials are part of AstraZeneca's comprehensive clinical development program for capivasertib[1].

Market Analysis and Projections

Current Market Scenario

The approval of capivasertib for hormone receptor-positive, HER2-negative metastatic breast cancer has opened up new treatment options for patients with specific genetic alterations in the AKT pathway. This has significant implications for the market, as it expands the therapeutic landscape for this subtype of breast cancer[4].

Forecasted Sales

Market forecasts indicate that capivasertib is expected to see substantial growth from 2024 to 2032. The drug's inclusion in treatment guidelines and its potential in combination therapies are key drivers of this growth. Reports from DelveInsight and other market research firms provide detailed forecasts and analyses, highlighting the drug's market potential and competitive landscape[2][5].

Competitive Landscape

Capivasertib faces competition from other therapies targeting similar patient populations, such as alpelisib. However, its unique mechanism of action and the results from the CAPItello-291 trial position it as a significant player in the market. The absence of head-to-head trials between capivasertib and other AKT pathway inhibitors means that treatment selection will be based on side-effect profiles and other clinical considerations[4].

Regulatory Milestones

The FDA approval of capivasertib for hormone receptor-positive, HER2-negative metastatic breast cancer is a critical regulatory milestone. This approval, along with ongoing and planned clinical trials, underscores the drug's potential for further indications and combinations[4].

Clinical Implications and Guidelines

Molecular Diagnostics

The use of molecular diagnostics to identify patients with PIK3CA, AKT1, and PTEN mutations is becoming increasingly important. These genetic alterations make patients potential candidates for capivasertib treatment. Clinical guidelines now recommend molecular testing to guide treatment decisions[4].

Treatment Selection

The approval of capivasertib presents clinicians with new considerations for treatment selection. Factors such as side-effect profiles, patient genetic profiles, and the presence of specific mutations will influence the choice between capivasertib and other available therapies[4].

Future Directions and Challenges

Ongoing Research

Ongoing clinical trials, such as CAPItello-292, are aimed at understanding the efficacy and safety of capivasertib in combination with other therapies. These trials will help clarify the role of capivasertib in various treatment settings and its potential in treating other types of cancer[2][5].

Long-Term Outcomes

There is a need for long-term survival data from trials like CAPItello-291 to fully understand the impact of capivasertib on patient outcomes. Additionally, questions remain about the drug's effect on tumors without AKT pathway mutations[4].

Key Takeaways

  • Mechanism of Action: Capivasertib is a pan-Akt kinase inhibitor targeting the AKT pathway, crucial for cancer cell survival and proliferation.
  • Clinical Trials: The CAPItello-291 trial showed significant improvement in progression-free survival, leading to FDA approval. Ongoing trials include CAPItello-292 and others in prostate cancer.
  • Market Analysis: Forecasted sales indicate substantial growth from 2024 to 2032, driven by its inclusion in treatment guidelines and potential in combination therapies.
  • Clinical Implications: Molecular diagnostics play a crucial role in identifying potential candidates. Treatment selection will be influenced by genetic profiles and side-effect profiles.
  • Future Directions: Ongoing research aims to clarify the drug's role in various treatment settings and its long-term outcomes.

FAQs

What is capivasertib and how does it work?

Capivasertib is a pan-Akt kinase inhibitor that targets the AKT pathway, preventing substrate phosphorylation and down-regulating AKT downstream substrates, thereby inhibiting cancer cell survival and proliferation[5].

What are the current indications for capivasertib?

Capivasertib is currently indicated for the treatment of patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with specific genetic alterations in the AKT pathway, following progression on at least one endocrine-based regimen[1][4].

What were the results of the CAPItello-291 trial?

The CAPItello-291 trial demonstrated a statistically significant improvement in progression-free survival in patients treated with capivasertib plus fulvestrant compared to the placebo plus fulvestrant group[3][4].

What are the ongoing clinical trials for capivasertib?

Ongoing trials include the CAPItello-292 trial evaluating the tri-combination of capivasertib, fulvestrant, and a CDK4/6 inhibitor, and the CAPItello-280 and CAPItello-281 trials in patients with prostate cancer[2][5].

How does capivasertib fit into the current market landscape for breast cancer treatments?

Capivasertib is a significant player in the market for hormone receptor-positive, HER2-negative metastatic breast cancer, offering a new treatment option for patients with specific genetic alterations. It competes with other therapies like alpelisib, and treatment selection will be based on genetic profiles and side-effect profiles[4].

Sources

  1. Onclive: Capivasertib Plus Paclitaxel Misses OS End Points in Advanced Triple-Negative Breast Cancer.
  2. ResearchAndMarkets: Capivasertib Emerging Drug Insight and Market Forecast - 2032.
  3. Cancer Research Horizons: Positive Phase III clinical trial results point to promise of capivasertib treatment.
  4. ASCO Post: Rapid Guideline Update Supports Capivasertib for Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer.
  5. DelveInsight: Capivasertib Emerging Drug Insight and Market Forecast - 2032.

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