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AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations

NCT03310541 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-06

No results posted yet for this study

Summary

This study will test the recommended dose of AZD5363 (recommended from a previous phase 1 study of the drug) in patients with specific AKT mutations. In patients who have ER positive breast cancer with an AKT mutation, they will also be receiving a standard breast cancer drug called fulvestrant that is given as an injection. In patients who have prostate cancer with an AKT mutation, they will also be receiving a standard prostate cancer drug called enzalutamide that is taken orally.

Conditions

Interventions

DRUG

AZD5363

AZD5363 400mg PO twice daily for 4 days on, 3 days off, every week

DRUG

Enzalutamide

Enzalutamide 160 mg PO once daily

DRUG

Fulvestrant

500mg IM days 1, 15, 29 (cycle 2 day 1) and then every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Alison Schram, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2023-05-03
Completion
2023-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03310541 on ClinicalTrials.gov