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PI3K/mTOR Inhibitor

Enzalutamide for Prostate Cancer

Phase 1

Waitlist Available

Led By Dana Rathkopf, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

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 1 year

Awards & highlights

Study Summary

This trial will help researchers understand if the combination of two drugs, enzalutamide and CC-115, is effective in treating patients with prostate cancer that has resisted other treatments.

Eligible Conditions

Castration-resistant Prostate Cancer
Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

establish the maximum tolerated dose (MTD)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Enzalutamide plus CC-115Experimental Treatment2 Interventions

The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until the maximum tolerated dose is identified. Participants at each site will participate in the dose escalation phase of the study. During the dose escalation phase, study participants will be assigned sequentially to three dose levels in groups (cohorts) of 3 to 6 subjects per dose level: Cohort 1: CC-115 at 5 mg dose twice a day & enzalutamide at 160 mg once a day. Cohort 2: CC-115 at 10 mg dose twice a day & enzalutamide at 160 mg once a day. The protocol has been amended to accrue an additional in the expansion phase treated at 7.5 mg BID. Amended to treat expansion group with 5mg BID of CC-115.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

CC-115

2016

Completed Phase 1

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,580 Total Patients Enrolled

132 Trials studying Prostate Cancer

52,034 Patients Enrolled for Prostate Cancer

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,196 Total Patients Enrolled

8 Trials studying Prostate Cancer

358 Patients Enrolled for Prostate Cancer

Dana Rathkopf, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

5 Previous Clinical Trials

124 Total Patients Enrolled

3 Trials studying Prostate Cancer

87 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

To what extent can Enzalutamide be detrimental to patients' well-being?

"Since the available data on Enzalutamide is limited, our evaluation of its safety yielded a score of 1."

Answered by AI

Are there any other venues in which this medical experiment is being conducted locally?

"Currently, 5 clinical trial sites are engaging in patient recruitment for this study. These locations include New york, Seattle, Durham and other nearby cities - it is advised to choose the closest enrolment site to reduce travel-related stressors."

Answered by AI

Is enrollment currently open for this medical experiment?

"Unfortunately, this clinical trial is not taking on any more participants at the moment. It was first introduced to clinicaltrials.gov in July 1st 2016 and its last update occurred on March 18th 2022 - however, there are over 1400 other studies actively recruiting patients currently."

Answered by AI

What is the current size of this clinical investigation?

"Unfortunately, recruitment for this clinical trial has been concluded. The study was first advertised on July 1st 2016 and the last update was posted on March 18th 2022. If a patient is considering other trials, 1324 studies are recruiting those with prostate cancer while 98 are looking to enrol patients taking Enzalutamide."

Answered by AI

What other experiments have been completed which looked at Enzalutamide?

"At present, 98 clinical trials are studying the effects of Enzalutamide. 30 of these active investigations are at Phase 3, with Germantown in Tennessee serving as the main centre for research. However, there exist 5740 other locations conducting experiments involving this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of an Experimental Drug, CC-115, With Enzalutamide in Men With Castration-Resistant Prostate Cancer

2016. "Use of an Experimental Drug, CC-115, With Enzalutamide in Men With Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02833883.