Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093990
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2004-10-07
Brief Title:
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia AML
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Study of Tipifarnib Versus Best Supportive Care Including Hydroxyurea in the Treatment of Newly Diagnosed Acute Myeloid Leukemia AML in Subjects 70 Years or Older Farnesyl Transferase Inhibition Global Human Trials AML 301 FIGHT AML 301
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70 or more with acute myeloid leukemia Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors FTI It blocks proteins that make leukemia cells grow
Detailed Description:
This study tests the safety and effectiveness of the experimental drug tipifarnib in older patients who have acute myeloid leukemia AML The purpose of this study is to test if tipifarnib can make patients with leukemia live longer In this study half the patients will receive tipifarnib and half of the patients will receive the standard treatment The standard treatment will help to control the symptoms of AML and may include hydroxyurea to lower levels of circulating leukemia cells Tipifarnib or the standard treatment will be given until the patients leukemia gets better or until they experience unacceptable side effects or until the patient or study doctor decide to stop the study medication Patients assigned to tipifarnib will be given tipifarnib tablets Patients should take 6 tablets with food in the morning and 6 tablets with food in the evening for 21 days in a row Patients will not take tipifarnib for the next 7 days This 28 day period is called a cycle The rest period may be extended beyond 7 days depending on how well the patients tolerate the treatment Patients will return to the study clinic every week and to visit their study doctor at least every two weeks A blood draw for routine tests will be done every week Depending on how your disease is doing a bone marrow aspiration may be done at the end of every cycle When patients finish treatment with the study medication or if they leave the study early they will be asked to see your doctor for one last visit Routine laboratory tests will be done After this visit the study doctor will continue to check with patients to see how they are doing and if they have started a new treatment for leukemia This check will be made every 30 days and may be made by phone to the patient or to their health care provider Tipifarnib six 100 mg in a film coated compressed tablets are given orally twice a day at for 21 consecutive days on a 28-day cycle schedule
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