Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024648
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2001-09-24
Brief Title:
Study to Determine Maximum Tolerated Dose of LErafAON Combined With Radiotherapy in Patients With Advanced Malignancies
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
Phase I Study to Determine the Maximum Tolerated Dose of LErafAON in Combination With Radiotherapy in Patients With Advanced Malignancies
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 malignancies will receive daily IV infusions of LErafAON for 2 weeks total of 10 doses during clinically indicated palliative radiotherapy Cohorts of at least three patients will be entered at escalating dose-levels Each cohort will be observed for toxicity for at least two weeks after completion of treatment with study medication before the next cohort is enrolled The study will be stopped when a maximum tolerated dose MTD is identified Dose escalation within a patient will not be allowed Safety and supportive care requirements will be assessed
Patients with advanced malignancies will receive daily IV infusions of LErafAON for 2 weeks total of 10 doses during clinically indicated palliative radiotherapy Cohorts of at least three patients will be entered at escalating dose-levels Each cohort will be observed for toxicity for at least two weeks after completion of treatment with study medication before the next cohort is enrolled The study will be stopped when a maximum tolerated dose MTD is identified Dose escalation within a patient will not be allowed Safety and supportive care requirements will be assessed
Detailed Description:
OBJECTIVES I Determine the toxicity and MTD of LErafAON administered in daily IV infusions in combination with radiotherapy to patients with advanced malignancies
II Characterize the plasma pharmacokinetics of LErafAON after IV infusion
III Assess in vivo inhibition of Raf-1 protein by LErafAON
IV Determine efficacy in radiated and non-radiated tumors
PROTOCOL OUTLINE This study is a traditional Phase I MTD study Cohorts of at least three patients will be entered at escalating dose-levels Patients will receive daily IV infusions of LErafAON for 2 weeks total of 10 doses Each cohort will be observed for at least two weeks post treatment with study medication to allow for observation of toxicity before the next cohort is enrolled Dose escalation will proceed until the MTD is identified Dose escalation within a patient will not be allowed
PROJECTED ACCRUAL Up to 27 patients at least 3 per dose level expanded to 6 if dose-limiting toxicity DLT occurs
II Characterize the plasma pharmacokinetics of LErafAON after IV infusion
III Assess in vivo inhibition of Raf-1 protein by LErafAON
IV Determine efficacy in radiated and non-radiated tumors
PROTOCOL OUTLINE This study is a traditional Phase I MTD study Cohorts of at least three patients will be entered at escalating dose-levels Patients will receive daily IV infusions of LErafAON for 2 weeks total of 10 doses Each cohort will be observed for at least two weeks post treatment with study medication to allow for observation of toxicity before the next cohort is enrolled Dose escalation will proceed until the MTD is identified Dose escalation within a patient will not be allowed
PROJECTED ACCRUAL Up to 27 patients at least 3 per dose level expanded to 6 if dose-limiting toxicity 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