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ATR Kinase Inhibitor

Ceralasertib for Cholangiocarcinoma

Phase 2
Waitlist Available
Led By Patricia M LoRusso
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post treatment
Awards & highlights

Study Summary

This trial is testing olaparib and ceralasertib to see if they can shrink IDH mutant tumors or stop them from growing.

Eligible Conditions
  • Cancer
  • Cholangiocarcinoma
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall survival (OS)
+1 more
Other outcome measures
2HG levels
Absolute and fold changes in gamma H2AX foci

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib, ceralasertib)Experimental Treatment8 Interventions
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~850
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Ceralasertib
2017
Completed Phase 1
~30
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,103 Total Patients Enrolled
101 Trials studying Cholangiocarcinoma
9,720 Patients Enrolled for Cholangiocarcinoma
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
5 Previous Clinical Trials
292 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
145 Patients Enrolled for Cholangiocarcinoma
Navid HafezPrincipal InvestigatorYale University Cancer Center LAO

Frequently Asked Questions

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

How many different hospitals are running this clinical trial?

"There are 10 different recruitment sites for this study, with locations in Houston, Chicago and Gainesville. To reduce the burden of travel on participants, it is recommended to select a clinic that is close to your home."

Answered by AI

Does Ceralasertib have any harmful side effects?

"Ceralasertib is still being tested for efficacy in human clinical trials, but it has received a score of 2 for safety."

Answered by AI

What are the most similar treatments to Ceralasertib?

"As of right now, there are 209 different clinical trials underway that are studying Ceralasertib. 27 of those studies are currently in Phase 3. Most of the trials for Ceralasertib take place in Houston, Texas; however, there are 9476 total locations running these sorts of experiments."

Answered by AI

Is Ceralasertib regularly used to treat a specific type of patient?

"Ceralasertib is commonly used to treat advance directives, but can also help manage malignant neoplasm of ovary, primary peritoneal cancer, and hallucinations, somatic."

Answered by AI

Have other researchers done anything similar to this before?

"Ceralasertib has been under investigation for over 15 years. The first Phase 1 clinical trial, which was sponsored by AstraZeneca, included 98 participants. After the successful completion of the 2005 study, Ceralasertib received drug approval. As of now, 209 active studies are being conducted in 1466 different cities and 59 countries around the world."

Answered by AI

Are we currently enrolling individuals for this research study?

"That is correct. The trial, which has been updated as recently as October 20th, 2020, is looking for 50 individuals to participate at 10 different sites."

Answered by AI

How many people can be enrolled in this trial?

"The most recent update to the listing on clinicaltrials.gov shows that this trial is still actively recruiting patients. The study was posted on December 2nd, 2019 and updated October 20th, 2020. They are looking for 50 individuals total from 10 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors
2020. "Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03878095.
~8 spots leftby Mar 2025
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