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Enzyme Inhibitor
RNR Inhibitor COH29 for Solid Tumors
Phase 1
Waitlist Available
Led By Joseph Chao
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Serum creatinine =< 1.5 mg/dL or a measured creatinine clearance >= 50 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and 15 minutes, 30 minutes, 1, 2 , 3, 4, 6, 8, 24, and 168 hours post the day 1, course 1 dose
Awards & highlights
Study Summary
This trial studies a drug to treat solid tumors that are not responding to standard treatments or for which no standard treatment exists. The drug may stop tumor cells from growing. #Cancer #ClinicalTrial
Who is the study for?
This trial is for patients with solid tumors that haven't responded to standard treatments or have no standard options left. They must be able to consent, have a life expectancy over 3 months, and an ECOG status of <=2. Participants need adequate blood counts, organ function, and agree to use contraception. Those with recent heart issues, active breastfeeding, uncontrolled illnesses or taking other investigational drugs can't join.Check my eligibility
What is being tested?
The study tests the safety and optimal dosage of COH29 in patients with advanced solid tumors. COH29 aims to block ribonucleotide reductase which may stop tumor growth. The trial includes lab biomarker analysis and pharmacological studies to understand how the drug works in the body.See study design
What are the potential side effects?
Potential side effects of COH29 are not fully known as this is a Phase I trial determining safety; however, they could include typical reactions seen with cancer therapies such as fatigue, nausea, liver enzyme changes, blood count variations and possibly others based on its mechanism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My kidney function is normal or only slightly reduced.
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My cancer is spreading, can't be surgically removed, and standard treatments aren't working.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after completion of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of RNR inhibitor COH29, defined as the dose level with no more than 1 dose limiting toxicity (DLT) in the first 6 patients at a dose level below a dose level with DLT in 2 of 6 patients, graded according to CTCAE version 4.0
Secondary outcome measures
Changes in plasma biomarker expression levels
Pharmacokinetics of RNR inhibitor COH29
RR protein levels as assessed by automated quantitative analysis (AQUA)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (RNR inhibitor COH29)Experimental Treatment3 Interventions
Patients receive RNR inhibitor COH29 PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,141 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,448 Total Patients Enrolled
Joseph ChaoPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
78 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.My kidney function is normal or only slightly reduced.I am not taking any experimental drugs or herbal medications.I do not have active heart problems like recent heart attack or uncontrolled heart failure.My cancer is spreading, can't be surgically removed, and standard treatments aren't working.I haven't had chemotherapy or radiation in the last 4 weeks.You must have a disease that can be measured or evaluated by doctors.I cannot or do not want to swallow pills.I have never had noninfectious pneumonitis.My brain metastases have been stable for at least 4 weeks.I had radiation therapy that affected less than 30% of my bone marrow over 4 weeks ago and have recovered from its immediate side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (RNR inhibitor COH29)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned the use of RNR inhibitor COH29 as a form of therapy?
"The RNR inhibitor COH29 has only been evaluated in a limited capacity, so it receives an estimated safety rating of 1."
Answered by AI
Are recruitment opportunities still available for this trial?
"Per clinicaltrials.gov, this particular medical experiment is not currently accepting patients due to the last date of update being on March 17th 2023. Nonetheless, there are many other trials still actively seeking participants; a total of 2475 studies in all."
Answered by AI
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