All > Paid Studies Philadelphia > Recurrent Ovarian Cancer

Arm I (selumetinib, olaparib) for Fallopian Tube Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
OptumCare Cancer Care at Charleston, Las Vegas, NVFallopian Tube Cancer+3 MoreOlaparib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial studies treating recurrent/persistent ovarian/endometrial cancer with RAS mutation with selumetinib+olaparib to increase tumor shrinkage & stability compared to selumetinib alone.

Eligible Conditions
  • Recurrent Fallopian Tube Cancer
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Ovarian Cancer
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Arm I (MRI, resection, DFMO, AMXT 1501)
1
Treatment (abemaciclib, olaparib, biospecimen collection)
1
Treatment (olaparib, durvalumab, radiation therapy)

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Year 5
Progression-free survival (PFS)
Year 5
Duration of response of both arms
Up to 5 years
Concordance between the diagnostic tumor mutation profile, biopsy mutations, and pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutations
Incidence of adverse events (AE)
ORR
ORR in crossover patients
Therapeutic procedure
Month 6
Heart rate

Trial Safety

Safety Progress

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

Similar Trials

1
Arm I (MRI, resection, DFMO, AMXT 1501)
1
Treatment (abemaciclib, olaparib, biospecimen collection)
1
Treatment (olaparib, durvalumab, radiation therapy)

Trial Design

2 Treatment Groups

Arm II (selumetinib)
1 of 2
Arm I (selumetinib, olaparib)
1 of 2

Active Control

Experimental Treatment

165 Total Participants · 2 Treatment Groups

Primary Treatment: Arm I (selumetinib, olaparib) · No Placebo Group · Phase 2

Arm I (selumetinib, olaparib)Experimental Group · 6 Interventions: Olaparib, Bone Marrow Aspiration and Biopsy, Selumetinib Sulfate, Biospecimen Collection, Computed Tomography, Biopsy · Intervention Types: Drug, Procedure, Drug, Procedure, Procedure, Procedure
Arm II (selumetinib)ActiveComparator Group · 5 Interventions: Bone Marrow Aspiration and Biopsy, Selumetinib Sulfate, Biospecimen Collection, Computed Tomography, Biopsy · Intervention Types: Procedure, Drug, Procedure, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2017
Completed Phase 4
~1430
Selumetinib Sulfate
2017
Completed Phase 2
~60
Biospecimen Collection
2004
Completed Phase 1
~670
Computed Tomography
2017
Completed Phase 2
~3410
Biopsy
2014
Completed Phase 4
~1120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

NRG OncologyOTHER
220 Previous Clinical Trials
95,600 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,153 Previous Clinical Trials
41,162,143 Total Patients Enrolled
Shannon N WestinPrincipal InvestigatorNRG Oncology
11 Previous Clinical Trials
1,230 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can have had any amount of treatment before enrolling in the study.
You have previously received treatment for your disease, but it did not work and your condition has worsened.
If you have endometrial cancer, you must have been offered or taken an immune oncology drug (by itself or with lenvatinib), unless there are reasons why you can't take these types of drugs.
References

Frequently Asked Questions

How many subjects are engaged in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, first posted on March 6th 2023, is actively accepting participants. A total of 165 subjects will be recruited from a single site." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies for participants in this clinical research?

"Indeed, clinicaltrials.gov confirms that this medical study is currently accepting enrollees. It was initially published on March 6th 2023 and has been recently revised as of March 8th 2023. This trial seeks to enroll 165 patients from a single site." - Anonymous Online Contributor

Unverified Answer

Has the combination of selumetinib and olaparib received governmental sanction by the FDA?

"Our team at Power assigned Arm I (selumetinib, olaparib) a safety rating of 2 on the 1 to 3 scale. This reflects that selumetinib and olaparib have been proven safe in clinical trials but not yet effective for patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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