ClarIDHy
The Study Design
What was a phase 3, randomized, placebo-controlled, multi-center study
The primary end point and hazard ratio
What is the 63% with a hazard ration of 0.37?
The most common adverse reactions (15%)
What are fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash
The dosage and administration of Voranigo
What is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity
(Fill in the blanks) The median OS for Tibsovo was _____ while the median OS for placebo was _____with hazard ratio of ____
What is 10.3 vs. 7.5 with a hazard ration of 0.09?
The number of prior therapies patients had to be eligible for the ClarIDHy Study and the name of one or more or the chemo regimens involved
What was 1-2 prior therapies and at least one of the following: gemcitabine/ciplatin or 5-FU containing regiment
The percentage of patients that were progression free at 6 months and 12 months.
What is 32% and 22% respectively
The most common lab abnormalities (>10%)
What are AST increase, Bilirubin increase, and hemoglobin decrease
If a dose is missed or not taken at the usual time
What is take the missed dose ASAP and at least 12 hours prior to the next scheduled dose and should return to the normal schedule; they should not take with in 12 hours.
Confounds the OS data
What is patients were permitted to crossover for radiographic disease progression?
The guidelines used to measure lesions in the ClarIDHy study
What is the RECIST or Response Evaluation Criteria in Solid Tumors?
The disease control rate for Tibsovo vs. placebo
What is 53 % (51% stable disease + 2% partial response vs 28% placebo
What are 29%, 4.1% and 7% respectively
Tibsovo should be not be _____, _____, and ____. Tibsovo should also not be taken with this type of meal
What is split, crushed or chewed?
What is high fat meal?
The prespecified statistical model used to adjust for treatment switching in oncology trials from placebo to the treatment arm
What is RPSFT or Rank Preserving Structural Failure Time?
The endpoints that were studied in the ClarIDHy trial. (There were 5)
What are PFS, secondary endpoint OS, Overall response rate, safety and QOL
(Fill in the blank) The median PFS for Tibsovo is ___ and for placebo it is __
What is the median PFS for Tibsovo is 2.7 months vs. 1.4 months for placebo
The most common adverse reaction that led to dose reduction
What is ECG QT prolongation?
The action if the QTc interval is greater than 480 msec
What is monitor/supplement electrolytes, review/adjust medication (QTc prolonging), hold Tibsovo; resume Tibsovo dose at 500 mg when QTc returns to 30 msec of base line or less than or equal to 480 msec; monitor ECG every 2 weeks till resolution of QTC prolongation
When adjusted for crossover the median OS for the placebo group was ___ and the hazard ratio was ___.
What is 5.1 months with a hazard ratio of 0.49?
The number of patients randomized to placebo and the percentage of patients that crossed over to receive Tibsovo and for what reason.
What is among 61 patients that were randomized to the placebo arm 70% of patients were allowed to cross over to receive Tibsovo after confirmed disease progression.
The percentage of patients that remained on Tibsovo for over a year
What is 15%
The most common reaction leading to permanent discontinuation
What is acute kidney injury?
(Fill in the blank) When taken together strong CYP3A4 inducers _______ while strong CYP3A4 inhibitors _______Tibsovo
What is decrease; increase the blood plasma concentration ?
The assumption for the RPSFT model is based on
What is that the treatment effect of Tibsovo is the same for all individuals regardless of when the treatment was received