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IDH1 Inhibitor
IDH305 for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 2
Documented IDH1R132-mutant tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study Summary
This trial is testing a new drug for people with cancer who have a specific mutation.
Who is the study for?
This trial is for patients with advanced cancers that have a specific genetic change called IDH1R132 mutation. They should be relatively active and able to care for themselves (ECOG ≤ 2). It's not open to those who've tried similar IDH1 inhibitors, except if they have glioma, or those with serious heart, lung, stomach, kidney, liver or nerve diseases. Pregnant or breastfeeding women can't join.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a drug named IDH305 on patients whose tumors have the IDH1R132 mutation. This early-phase trial will help determine how well this treatment works and what doses are safe.See study design
What are the potential side effects?
Potential side effects of IDH305 aren't detailed here but may include typical reactions seen in cancer treatments such as fatigue, nausea, diarrhea or allergic reactions. The exact side effects will be monitored closely due to the novel nature of this therapy.
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.
Select...
My tumor has an IDH1R132 mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incident rate of dose limiting toxicities (DLTs)
Secondary outcome measures
Changes of 2-hydroxyglutarate concentration in patient specimens
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAE)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IDH305Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,184 Total Patients Enrolled
7 Trials studying Advanced Malignancies
354 Patients Enrolled for Advanced Malignancies
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.I have been diagnosed with Acute Promyelocytic Leukemia.My tumor has an IDH1R132 mutation.I am not pregnant or breastfeeding.I have been treated with an IDH1 inhibitor before, except if I had a glioma.I do not have any major health issues that would stop me from safely participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: IDH305
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 IDH305 been accredited by the FDA?
"IDH305's safety is deemed to be moderate with a score of 1, as this Phase 1 trial lacks sufficient evidence regarding its efficacy and safety."
Answered by AI
Are multiple medical centers currently conducting this experiment in the city?
"At present, 4 medical centres are recruiting patients for this study - namely Columbia University Medical Center- New york Presbyterian Onc Dept. in New York, University of Texas MD Anderson Cancer Centre in Houston, Novartis Investigative Site in Toronto and a further four locations."
Answered by AI
Are there any opportunities for patient enrollment in this trial currently?
"Clinicaltrials.gov states that this research initiative is not actively recruiting participants at the moment, despite being posted on 6th January 2015 and updated as recent as 9th December 2021. Fortunately, there are 2380 other medical trials currently enrolling patients."
Answered by AI
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