Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024661
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2001-09-24
Brief Title:
Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Solid Tumors
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
Study to Determine the Maximum Tolerated Dose of Liposome-Encapsulated C-RAF Antisense Oligodeoxynucleotide LErafAON in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-04
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:
LErafAON is a liposome encapsulated c-raf antisense oligonucleotide Raf-1 is a protein produced by human cells both normal and cancerous which may help protect tumor cells from radiation Antisense oligonucleotides are very specific drugs which can decrease the amount of a certain target protein by blocking the gene that makes it Antisense oligonucleotide to raf gene can reduce the amount of Raf-1 protein in tumor cells Liposomes are tiny globules of fat which can carry drugs in the body The experimental agent LErafAON is composed of liposomes carrying antisense oligonucleotide against the Raf-1 protein It is hoped that decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy
Patients with advanced solid tumors will receive IV infusions of LErafAON over at least 60 minutes once per week for 8 weeks In the absence of progression patients may continue on weekly treatment Pre-medications will be administered prior to each dose of study medication
Cohorts of at least three patients will be entered at escalating dose-levels Each cohort will be observed for at least ten days after receiving the first dose of treatment before additional patients are treated at a higher dose level Patients will be followed for one month after receiving the last dose of study medication The study will stop when a maximum tolerated dose MTD is identified Dose escalation within a patient will not be allowed
Patients with advanced solid tumors will receive IV infusions of LErafAON over at least 60 minutes once per week for 8 weeks In the absence of progression patients may continue on weekly treatment Pre-medications will be administered prior to each dose of study medication
Cohorts of at least three patients will be entered at escalating dose-levels Each cohort will be observed for at least ten days after receiving the first dose of treatment before additional patients are treated at a higher dose level Patients will be followed for one month after receiving the last dose of study medication The study will stop when a maximum tolerated dose MTD is identified Dose escalation within a patient will not be allowed
Detailed Description:
OBJECTIVES I Determine the toxicity and MTD of LErafAON when given by weekly IV infusion for 8 weeks in patients with advanced malignancies
II Characterize the plasma pharmacokinetics of LErafAON after IV infusion
III Document in vivo inhibition of Raf-1 protein by LErafAON
IV Detect anti-tumor effects of intravenous LErafAON
PROTOCOL OUTLINE This is a Phase I Maximum Tolerated Dose MTD study for patients with recurrent solid tumor malignancies Study medication will be administered by intravenous infusion over at least 60 minutes once per week for 8 weeks In the absence of progression patients may continue on weekly treatment Pre-medications will be administered prior to each dose of study medication Patients will be followed for one month after receiving the last dose of study medication Patients with Complete Response CR Partial Response PR or Stable Disease SD at the Week 8 disease assessment may continue to receive study medication until disease progression PD
Cohorts of at least three patients will be entered at escalating dose-levels Each cohort will be observed for at least ten days after receiving the first dose of treatment before additional patients are treated at a higher dose level Patients will be followed for one month after receiving the last dose of study medication The study will stop when a maximum tolerated dose MTD is identified Dose escalation within a patient will not be allowed
PROJECTED ACCRUAL Estimated enrollment is 15-35 patients 3 per dose level expanded to 6 if DLT occurs
II Characterize the plasma pharmacokinetics of LErafAON after IV infusion
III Document in vivo inhibition of Raf-1 protein by LErafAON
IV Detect anti-tumor effects of intravenous LErafAON
PROTOCOL OUTLINE This is a Phase I Maximum Tolerated Dose MTD study for patients with recurrent solid tumor malignancies Study medication will be administered by intravenous infusion over at least 60 minutes once per week for 8 weeks In the absence of progression patients may continue on weekly treatment Pre-medications will be administered prior to each dose of study medication Patients will be followed for one month after receiving the last dose of study medication Patients with Complete Response CR Partial Response PR or Stable Disease SD at the Week 8 disease assessment may continue to receive study medication until disease progression PD
Cohorts of at least three patients will be entered at escalating dose-levels Each cohort will be observed for at least ten days after receiving the first dose of treatment before additional patients are treated at a higher dose level Patients will be followed for one month after receiving the last dose of study medication The study will stop when a maximum tolerated dose MTD is identified Dose escalation within a patient will not be allowed
PROJECTED ACCRUAL Estimated enrollment is 15-35 patients 3 per dose level expanded to 6 if DLT occurs
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