Capivasertib for Neoplasms, Plasma Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Neoplasms, Plasma Cell+9 More
Capivasertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effects of AZD5363 on patients with cancer that has a genetic change called AKT mutation. AZD5363 may block AKT, which is a protein needed for cancer cell growth.

Eligible Conditions
  • Neoplasms, Plasma Cell
  • Refractory Plasma Cell Myeloma
  • Lymphoma
  • Lymphoid Cells
  • Malignant Neoplasms
  • Advance Directives
  • Refractory Lymphomas

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Year 3
Progression Free Survival (PFS)
Year 3
6-month Progression-free Survival (PFS) Rate
Year 3
Overall Response Rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (capivasertib)
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Capivasertib · No Placebo Group · Phase 2

Treatment (capivasertib)
Drug
Experimental Group · 1 Intervention: Capivasertib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,995 Previous Clinical Trials
41,299,901 Total Patients Enrolled
497 Trials studying Neoplasms, Plasma Cell
85,439 Patients Enrolled for Neoplasms, Plasma Cell
Kevin M KalinskyPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
10,000 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an AKT mutation.
You have diabetes mellitus or a risk for hyperglycemia.
You must meet applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.