Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478946
Status:
UNKNOWN
Last Update Posted:
2009-01-21
First Post:
2007-05-23
Brief Title:
A Study of Picoplatin in Colorectal Cancer
Sponsor:
Poniard Pharmaceuticals
Organization:
Poniard Pharmaceuticals
Study Overview
Official Title:
A Phase I Open-Label Study of Picoplatin in Combination With 5-Fluorouracil and Leucovorin as Initial Therapy in Subjects With Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colorectal cancer is a type of cancer that begins in the large intestine colon or the rectum end of the colon Several drugs are often given in combination to treat colorectal cancer One of the most active treatment combinations is known as FOLFOX which is a combination of 5-fluorouracil 5-FU leucovorin and oxaliplatin Oxaliplatin is a type of platinum drug and was approved by the FDA in 2004 While generally well-tolerated oxaliplatin may cause toxicity to the nerves such as sensory loss or cold sensitivity
Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers No significant nerve toxicity has been seen in previous studies of picoplatin
This study will review the safety and effectiveness of FOLPI which is the combination of 5-FU and leucovorin with picoplatin in participants with colorectal cancer
Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers No significant nerve toxicity has been seen in previous studies of picoplatin
This study will review the safety and effectiveness of FOLPI which is the combination of 5-FU and leucovorin with picoplatin in participants with colorectal cancer
Detailed Description:
Subjects will be randomized centrally to treatment with picoplatin administered either every two or every four weeks and will be assigned a dose of picoplatin dependent on the study results to date Each patient will also receive therapy every two weeks with 5-FU and leucovorin In each schedule the cohort size will be 3 subjects to be expanded to 6 subjects if a dose-limiting toxicity is observed If not dose-limiting toxicity observed among the 3 subjects within a cohort picoplatin dose escalation may proceed until the maximum tolerated dose is established
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None