This from https://clinicaltrials.gov/study/NCT05747794
The main objectives of the dose optimization lead-in (phase 2) are to evaluate and compare the safety and tolerability of 2 different dose levels of efti (30 mg and 90 mg) combined with paclitaxel, and to define the optimal biological dose (OBD) of efti in combination with weekly paclitaxel for the phase 3 part of the trial. Recruitment to the dose-optimization lead-in will be considered complete when 29 participants per cohort are randomized and considered evaluable for OBD analysis.The main objective of the phase 3 is to demonstrate that overall survival (OS) is superior in participants treated with efti combined with weekly paclitaxel compared to weekly paclitaxel plus placebo. Approximately 771 participants will be randomized 2:1 to Arm A (active arm): paclitaxel + efti at OBD and Arm B (control arm): paclitaxel + placebo. The exact patient population will be defined after determination of the OBD.The duration of the trial will be approximately 24 months for the dose optimization lead-in component and 60 months for the phase 3 component. The phase 3 will start prior to the completion of the phase 2 (once the OBD has been defined).
What am i missing???. I understand that we have recruited 23 out of 29 patients. Once analysis is then completed then we proceed to recruitment of 771 patients and the trial can then be 24 months for dosage optimisation and up to 60 months for completion. Are we to wait another up to 5 more years. I have been waiting over 10 at this stage.
- Forums
- ASX - By Stock
- IMM
- Overnight Market report
Overnight Market report, page-2575
-
- There are more pages in this discussion • 305 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add IMM (ASX) to my watchlist
(20min delay)
|
|||||
Last
30.5¢ |
Change
-0.010(3.17%) |
Mkt cap ! $443.6M |
Open | High | Low | Value | Volume |
31.0¢ | 31.8¢ | 30.5¢ | $1.050M | 3.399M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
3 | 334744 | 30.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
31.0¢ | 5285 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
3 | 334744 | 0.305 |
25 | 429113 | 0.300 |
9 | 120834 | 0.295 |
11 | 509636 | 0.290 |
9 | 1056625 | 0.285 |
Price($) | Vol. | No. |
---|---|---|
0.310 | 5285 | 1 |
0.315 | 7174 | 2 |
0.320 | 115546 | 6 |
0.325 | 239718 | 4 |
0.330 | 26299 | 3 |
Last trade - 16.10pm 16/10/2024 (20 minute delay) ? |
Featured News
IMM (ASX) Chart |
The Watchlist
JBY
JAMES BAY MINERALS LIMITED
Andrew Dornan, Executive Director
Andrew Dornan
Executive Director
SPONSORED BY The Market Online