Some Interesting Statistics
Add up the numbers and it is quite surprising, products to make it had a combined (full, partial, or minimal) response of 8.3%....products that did not statistically averaged 4.3% for the combined numbers
asco.org
Duration on a Phase 1 Study: Early Evidence of Drug Activity?
Janet Dancey, Louise Grochow, Susan Arbuck, William Price, National Cancer Institute, Rockville, MD; Theradex, Princeton, NJ.
Purpose: To determine whether duration on a phase 1 study is predictive of drug activity sufficient for licensing. Methods: Using the National Cancer Institute Clinical Trial Monitoring System Database, all phase 1 trials of single agents in adult solid tumor patients conducted from 1979-2000 were identified. Agents were classified as "active" or "inactive" based on the whether they eventually were registered for treatment of a solid tumor malignancy. Duration on study, number of cycles, and responses were tabulated for all off-study patients and compared. Results: Results are summarized in the table below. The response rates and duration on study were significantly longer for active agents (p<0.001). The median and average number of cycles were also longer for active agents. Conclusions: Both on-study duration and the response percentages differ between active and inactive agents in this large dataset of phase 1 trials of cytotoxics evaluated in solid tumor patients. Further analyses to determine whether duration on a phase 1 study for an investigational agent could be used to infer activity early in clinical development and predict successful registration are planned.
You need to go to the link to see the chart.
The study shows that drugs that have made it to eventually to treatment had the following results on average at the Phase 1 clinical trial stage. They labelled these drugs that were registered for treatment as "active"
1% Complete response
4.5% Partial Response
2.8% Minor response (stable disease)
with an average duration of 56 and 83 days
The drugs that were labelled as "inactive" that were not eventually registered for treatment had the following Phase 1 results
0.3% Complete Response
1.6% Partial Response
2.4% Minor response (stable disease)
with an average duration of 49 and 66days |
