NCT04087174 is a Phase 1 clinical trial of Capivasertib in Prostate Cancer, sponsored by AstraZeneca.

Who is sponsoring NCT04087174?

NCT04087174 is sponsored by AstraZeneca.

What drugs are being tested in NCT04087174?

Interventions in NCT04087174: Capivasertib, Enzalutamide, Abiraterone.

What condition does NCT04087174 study?

NCT04087174 studies Prostate Cancer.

Is NCT04087174 still recruiting?

NCT04087174 is currently completed. Last updated 13 July 2022.

Last reviewed 2022-07-13 · How we verify

NCT04087174

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer

Completed Phase 1 Last updated 13 July 2022

What this trial tests

Phase 1 trial testing Capivasertib in Prostate Cancer in 27 participants. Completed in 22 June 2021.

Timeline

5 August 2019

Primary endpoint
22 June 2021

22 June 2021

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	5 August 2019
Primary completion	22 June 2021
Estimated completion	22 June 2021
Sites	6 locations across United States, Spain

Drugs / interventions tested

Capivasertib — full drug profile →
Enzalutamide (enzalutamide) — full drug profile →
Abiraterone (ABIRATERONE) — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when given to patients with metastatic castration resistant prostate cancer (CRPC). The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting signaling pathways in prostate cancer: mechanisms and clinical trials.
He Y, Xu W, Xiao YT, Huang H, et al · · 2022 · cited 192× · PMID 35750683 · DOI 10.1038/s41392-022-01042-7
Role of PI3K-AKT-mTOR Pathway as a Pro-Survival Signaling and Resistance-Mediating Mechanism to Therapy of Prostate Cancer.
Pungsrinont T, Kallenbach J, Baniahmad A. · · 2021 · cited 148× · PMID 34681745 · DOI 10.3390/ijms222011088
The PTEN Conundrum: How to Target PTEN-Deficient Prostate Cancer.
Turnham DJ, Bullock N, Dass MS, Staffurth JN, et al · · 2020 · cited 52× · PMID 33105713 · DOI 10.3390/cells9112342
Clinical Development of AKT Inhibitors and Associated Predictive Biomarkers to Guide Patient Treatment in Cancer Medicine.
Coleman N, Moyers JT, Harbery A, Vivanco I, et al · · 2021 · cited 46× · PMID 34858045 · DOI 10.2147/pgpm.s305068
Molecular target: pan-AKT in gastric cancer.
Kang BW, Chau I. · · 2020 · cited 36× · PMID 32948630 · DOI 10.1136/esmoopen-2020-000728
Overview of the Development and Use of Akt Inhibitors in Prostate Cancer.
Gasmi A, Roubaud G, Dariane C, Barret E, et al · · 2021 · cited 29× · PMID 35011901 · DOI 10.3390/jcm11010160
Immunometabolism in cancer: basic mechanisms and new targeting strategy.
Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
Cancer Stem Cell for Tumor Therapy.
Huang B, Yan X, Li Y. · · 2021 · cited 27× · PMID 34638298 · DOI 10.3390/cancers13194814

Verify or expand the search:

Other trials of Capivasertib

Trials testing the same drug.

NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
NCT07241065 — A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in · Phase 1 · recruiting
NCT07287917 — Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07343960 — A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Imp · Phase 1 · recruiting
NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI · Phase 3 · recruiting

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04087174 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 13 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04087174.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing