Theratechnologies Inc T.TH

Amendment to trial design

[jeffm34]

This appears to have been added into the latest trial design amendment updated yesterday. Must have been something they've seen already in the phase 1a. Under exclusion criteria they have added: 

14. Have any of the following ocular conditions at baseline:

• Active or chronic corneal disorder, including but not limited to Sjogren's, Fuch's corneal dystrophy, history of corneal transplantation, active herpetic keratitis, as well as other active ocular conditions requiring ongoing therapy.
• Any clinically significant corneal disease that prevents adequate monitoring of drug induced keratopathy.
• Laser in-situ keratomileusis (LASIK) procedure performed within 1 year or less.
• Cataract surgery within 3 months or less.
• Patients will not be allowed to use contacts unless advised by an eye care provider for adverse event treatment during the study treatment.

[jeffm34]

An additional location has also been added. Mary Crowley cancer research in Dallas Texas

[qwerty22]

You are right about the ocular addition but when you look at the history of changes it shows they did an extensive rewrite on the whole inclusion/exclusion section and other parts. https://clinicaltrials.gov/ct2/history/NCT04706962?A=4&B=5&C=Side-by-Side#StudyPageTop  

[jfm1330]

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4677113/

[qwerty22]

The thing I think I heard Christian sorta mumbled at the financial year report in Feb was that the 3 AEs in the 420 group which were on top of the neutropenia DLT were all the type of side effects seen with docetaxel. It's so vague and they've used up all their trust points with me so who knows exactly what that means. I guess it all comes down to manageability.  

[Wino115]

That NCI update likely means they got no further questions back from the FDA like they stated, so it's all a go for the basket trial.  Have to assume many of the additional details are based on what they and the investigators have learned thus far. JFM should like the fac they've added a number of  exclusions to control the entry types even further which theoretically should

[qwerty22]

CRO - contract research organization