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AKT Inhibitor

Capivasertib for Non-Hodgkin's Lymphoma (CAPITAL Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status ≤ 2
Participants must be ≥ 18 years of age, at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death due to any cause (assessed up to 1.6 years)
Awards & highlights

CAPITAL Trial Summary

This trial is testing a new drug for people with a certain kind of cancer that has come back or does not respond to treatment.

Who is the study for?
Adults with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to treatment can join. They should have had at least two prior treatments, be in fairly good health (ECOG ≤ 2), and not pregnant or breastfeeding. People with certain other cancers, serious unresolved side effects from past treatments, brain involvement of lymphoma, poor bone marrow/organ function, uncontrolled diabetes needing insulin, or recent use of certain drugs are excluded.Check my eligibility
What is being tested?
The trial is testing Capivasertib given orally to see how well it works for people whose B-cell Non-Hodgkin's Lymphoma has relapsed or is refractory. It's a Phase II study which means they're looking at the effectiveness and safety of this drug across multiple centers where everyone gets the same treatment.See study design
What are the potential side effects?
While specific side effects for Capivasertib aren't listed here, similar cancer drugs often cause fatigue, nausea, diarrhea, low blood cell counts increasing infection risk and bleeding problems. There may also be liver issues and rash among others.

CAPITAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My diagnosis is Marginal Zone Lymphoma.
Select...
My condition worsened after 2 treatments.
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My lymphoma is confirmed as Follicular Lymphoma Grade 1, 2, or 3a.
Select...
I have previously received BTK inhibitor and Anti-CD20mAb therapy.
Select...
My diagnosis of mantle cell lymphoma has been confirmed through tissue examination.

CAPITAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death due to any cause (assessed up to 1.6 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death due to any cause (assessed up to 1.6 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with objective response
Secondary outcome measures
Change from baseline in health-related quality of life as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Duration of response (DoR)
Number of participants with AEs and Serious adverse events
+8 more

CAPITAL Trial Design

1Treatment groups
Experimental Treatment
Group I: Capivasertib monotherapyExperimental Treatment1 Intervention
Participants with R/R FL, R/R MZL, and R/R MCL will receive capivasertib orally until progression of disease (PD) or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
2021
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,756 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,796 Total Patients Enrolled

Media Library

Capivasertib (AKT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05008055 — Phase 2
B-Cell Non-Hodgkin Lymphoma Research Study Groups: Capivasertib monotherapy
B-Cell Non-Hodgkin Lymphoma Clinical Trial 2023: Capivasertib Highlights & Side Effects. Trial Name: NCT05008055 — Phase 2
Capivasertib (AKT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05008055 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being accepted for this trial?

"From what is listed on clinicaltrials.gov, this trial is still looking for participants and is thus actively recruiting patients. The listing was created on 11/3/2021 and last updated on 11/2/2022."

Answered by AI

Have there been similar medical studies to this one in the past?

"Capivasertib has been under research for just over a decade now. AstraZeneca first sponsored a trial in 2010, which resulted in Phase 1 approval after studying 285 patients. 23 different studies are ongoing as of now, conducted across 959 cities and 44 countries worldwide."

Answered by AI

What is the target number of enrollees for this clinical trial?

"Yes, that is accurate. According to the information on clinicaltrials.gov, this particular trial was originally posted on 11/3/2021 and is currently looking for 272 patients from 6 different sites."

Answered by AI

Might I be eligible to join this research project?

"Lymphoma patients that meet the age range of 18 to 130 and have diffuse lymphoma are encouraged to apply for this study. There is a goal of recruiting 272 total participants."

Answered by AI

What was the outcome of Capivasertib's FDA hearing?

"Capivasertib's safety is only supported by phase 2 data, meaning that there is not yet any clinical evidence indicating that the drug is effective. However, it did receive a score of 2 because there are no major safety concerns at this time."

Answered by AI

How many different hospitals are running this trial?

"Currently, there are six sites administering this trial with more locations in Victoria, Duarte and Los Angeles. To limit participant's travel burden, it is best to select a location closest to you."

Answered by AI

Are middle-aged adults welcome in this research project?

"This particular clinical study is open to patients aged 18-130. In contrast, there are 320 trials for minors and 1666 studies available for elderly patients."

Answered by AI

What else is known about Capivasertib from other research?

"As of now, 23 different clinical trials are underway to research Capivasertib. 4 of these trials have progressed to Phase 3. The majority of the tests for Capivasertib are being conducted in Montpellier, Ontario; however, 4213 unique locations around the world are running studies concerning Capivasertib."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
2021. "Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05008055.
~9 spots leftby Apr 2025
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