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Last Updated: January 26, 2022

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CLINICAL TRIALS PROFILE FOR CAPIVASERTIB


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Clinical Trials for Capivasertib

Trial ID Title Status Sponsor Phase 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 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 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 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 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 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 >Summary

Clinical Trial Conditions for Capivasertib

Condition Name

Condition Name for
Intervention Trials
Metastatic Breast Cancer 2
Recurrent Uterine Corpus Cancer 2
Recurrent Uterine Corpus Carcinoma 2
Refractory Lymphoma 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Breast Neoplasms 9
Neoplasms 4
Prostatic Neoplasms 3
Lymphoma 3
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Clinical Trial Locations for Capivasertib

Trials by Country

Trials by Country for
Location Trials
United States 259
Canada 21
France 7
Korea, Republic of 7
United Kingdom 6
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Trials by US State

Trials by US State for
Location Trials
Texas 12
California 10
Tennessee 9
New York 9
Pennsylvania 9
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Clinical Trial Progress for Capivasertib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 4
Phase 2 6
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 12
Active, not recruiting 3
Completed 3
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Clinical Trial Sponsors for Capivasertib

Sponsor Name

Sponsor Name for
Sponsor Trials
AstraZeneca 15
National Cancer Institute (NCI) 5
Parexel 4
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 21
Other 7
NIH 5
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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Moodys
Boehringer Ingelheim
Colorcon
Baxter

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