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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR CAPIVASERTIB


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All Clinical Trials for capivasertib

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT02465060 ↗ Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting National Cancer Institute (NCI) Phase 2 2015-08-12 This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for capivasertib

Condition Name

Condition Name for capivasertib
Intervention Trials
Metastatic Breast Cancer 5
Breast Cancer 5
Recurrent Ovarian Carcinoma 2
Refractory Malignant Solid Neoplasm 2
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Condition MeSH

Condition MeSH for capivasertib
Intervention Trials
Breast Neoplasms 16
Prostatic Neoplasms 5
Neoplasms 4
Lymphoma 4
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Clinical Trial Locations for capivasertib

Trials by Country

Trials by Country for capivasertib
Location Trials
United States 274
Canada 21
United Kingdom 8
France 7
Korea, Republic of 7
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Trials by US State

Trials by US State for capivasertib
Location Trials
Texas 15
California 11
Tennessee 10
Florida 9
Pennsylvania 9
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Clinical Trial Progress for capivasertib

Clinical Trial Phase

Clinical Trial Phase for capivasertib
Clinical Trial Phase Trials
PHASE3 4
PHASE2 3
PHASE1 6
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Clinical Trial Status

Clinical Trial Status for capivasertib
Clinical Trial Phase Trials
Recruiting 23
NOT_YET_RECRUITING 5
Completed 3
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Clinical Trial Sponsors for capivasertib

Sponsor Name

Sponsor Name for capivasertib
Sponsor Trials
AstraZeneca 26
Parexel 7
National Cancer Institute (NCI) 5
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Sponsor Type

Sponsor Type for capivasertib
Sponsor Trials
Industry 42
Other 15
NIH 5
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Capivasertib: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 20, 2026

What is the current state of clinical trials for Capivasertib?

Capivasertib (formerly AZD5363) is an oral AKT kinase inhibitor developed by AstraZeneca. Its clinical development primarily targets cancers with PI3K/AKT pathway aberrations, including breast, ovarian, endometrial, and prostate cancers.

Clinical trial phases

  • Phase I: Completed early safety and dosage studies. Data published show manageable safety profile with common adverse effects including hyperglycemia and gastrointestinal symptoms.
  • Phase II: Several trials ongoing, evaluating efficacy in specific cancer subtypes. Notably, a phase II trial with Capivasertib combined with fulvestrant in estrogen receptor-positive breast cancer demonstrated promising response rates.
  • Phase III: No publicly available phase III trial results. AstraZeneca announced plan to initiate larger studies in combination regimens for breast and prostate cancers based on phase II data.

Key trials

Trial Identifier Phase Status Focus Expected completion
FAKTION II Completed Capivasertib + fulvestrant in ER+ breast cancer 2022
PAKT II Recruiting Capivasertib + Paclitaxel in advanced breast cancer 2023
CAPItello-291 III Not yet started Capivasertib + fulvestrant vs. placebo + fulvestrant 2024

Recent updates

  • In March 2023, AstraZeneca published updated data indicating improved progression-free survival in ER+ breast cancer patients.
  • The company is pursuing accelerated pathways for certain indications, leveraging biomarker-driven strategies.

How does Capivasertib perform in the current oncology treatment landscape?

Market context

The global oncology drug market was valued at approximately USD 180 billion in 2022. Within this, targeted therapies account for about 55%, with kinase inhibitors constituting the largest segment.

Competitive landscape

Capivasertib faces competition from:

  • Alpelisib (Piqray): PI3K alpha-specific inhibitor approved for PIK3CA-mutated breast cancer.
  • Ipatasertib (GDC-0068): An AKT inhibitor in late-stage clinical testing.
  • Capivasertib: Differentiates through broader AKT isoform inhibition and combination potential.

Key differentiators

  • Biomarker support: Efficacy appears enhanced in tumors with PTEN loss or PIK3CA mutations.
  • Combination potential: Partners well with hormone therapy, chemotherapy, and immunotherapy.

Regulatory considerations

  • No approved indication for Capivasertib.
  • Regulatory submissions anticipated based on ongoing trial results, with potential fast-track designations for specific populations.

What is the market projection for Capivasertib?

Market size estimates

By 2027, the targeted oncology kinase inhibitor segment is projected to reach USD 75 billion, driven by monotherapy and combination regimens.

Revenue forecasts

  • 2023: Early-stage commercialization or licensing deals expected, with estimated revenues below USD 100 million.
  • 2025: Peak sales in select indications (such as ER+ breast cancer with specific biomarkers) could reach USD 500 million, contingent on approval and label expansion.
  • 2027: Market penetration could grow further, especially if randomized phase III data solidifies efficacy, with potential revenues exceeding USD 1 billion for the approved branches.

Key drivers

  • Biomarker screening capacity to identify suitable patients.
  • Approval of combination protocols extending indications.
  • Strategic licensing agreements with local and regional partners.

Risks

  • Delays or failures in phase III trials.
  • Competition from therapies with established standards.
  • Regulatory hurdles and cost of payer reimbursement.

Summary table: Market forecast at a glance

Year Estimated Revenue Key Factors
2023 <$100 million Early licensing deals, initial market entry
2025 ~$500 million Approval for ER+ breast cancer; expanded label potential
2027 >$1 billion Broader indication approvals; combination therapy adoption

Key Takeaways

  • Capivasertib demonstrates promising activity in ER+ breast cancer, especially with biomarker-driven approaches.
  • Clinical development is progressing toward phase III, with regulatory submissions anticipated in the next 2 years.
  • Market potential is substantial, contingent on successful trial outcomes and regulatory approvals.
  • The compound’s niche lies in combination strategies targeting specific molecular profiles.
  • Competitive pressures exist from other kinase inhibitors, but biomarker support and combination evidence favor Capivasertib’s positioning.

FAQs

1. What cancers are being targeted in Capivasertib trials?
Primarily breast, ovarian, endometrial, and prostate cancers with PI3K/AKT pathway mutations or loss of PTEN.

2. When might Capivasertib receive regulatory approval?
Potential approval timelines depend on upcoming phase III trial results, expected around 2024–2025.

3. How does Capivasertib compare to other AKT inhibitors?
It offers broader isoform inhibition and combination flexibility, with ongoing head-to-head or indirect comparison trials.

4. What biomarkers could influence Capivasertib’s efficacy?
PTEN loss and PIK3CA mutations are associated with improved responses.

5. What is the likelihood of market success for Capivasertib?
Dependent on positive phase III data, regulatory approval, and successful commercialization strategies in competing indications.


References

[1] AstraZeneca. (2023). Clinical trial updates for Capivasertib. Retrieved from AstraZeneca phase I-III trial registry.

[2] MarketResearch.com. (2023). Global oncology kinase inhibitor market forecasts. Specialty Reports.

[3] Food and Drug Administration (FDA). (2022). Guidelines for biomarker-based drug approvals.

[4] BioCentury. (2023). Pipeline review: Capivasertib in breast and prostate cancer. BioCentury Publications.

[5] ClinicalTrials.gov. (2023). Capivasertib study registry. National Library of Medicine.

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