Trials: Questions To Ask

Here are some questions that you might want to ask the investigator of the trial you are considering.

Since this is a Phase 1 trial, ask if it has a Dose Expansion part.  If so, ask if you are being considered for the Dose Expansion or the Dose Finding part.

Phase I: Dose-Finding

If you are told that you will be in the Dose-Finding (also called Dose Escalation) part, you might ask these questions to help you decide if you will enroll in the trial.

  1. How many patients have already been treated?  Do any of them have ovarian cancer?
  2. How many patients have received the same dose that I am going to get?  (Am I the first one to get this dose?)
  3. What side effects have other patients experienced?  How many patients had those side effects?
  4. If the trial is combining two drugs and one is already approved for treating cancer, you could ask if the dose you will get is the same as the dose typically given.   (If it is lower, is it a dose that would be expected to cause tumor shrinkage.)
  5. Have any of the patients had their tumors shrink after getting this drug?

Phase I: Dose Expansion

If you are told that you will be in the Dose expansion part, you might ask these questions to help you decide if you will enroll in the trial.

  1. How many patients have already been treated? Do any of them have ovarian cancer?
  2.  What side effects have other patients experienced in this part of the trial and in the previous dose-escalation phase?  How many patients had those side effects
  3. Have any of the patients had their tumors shrink after getting this drug?
  4. What is the longest time someone has taken this drug without their tumors growing?