Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293215
Status:
TERMINATED
Last Update Posted:
2022-10-10
First Post:
2006-02-15
Brief Title:
Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase I Biodistribution Study of 111-Indium-CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Abnormal distribution and lack of tumor targeting were observed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a Phase 1 dose-escalation study of CMD-193 a humanized monoclonal antibody linked to the toxin calicheamicin in subjects with advanced tumors expressing the Lewis-Y antigen The primary study objective was to determine the biodistribution and pharmacokinetics PK of 111-In-CMD-193 ie CMD-193 tagged with a small amount of radioactive Indium 111-In with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193
Detailed Description:
Subjects received a single infusion of 111-In-CMD-193 on Day 1 Collection of blood for PK and whole body gamma camera imaging for assessment of biodistribution and tumor uptake were performed on Days 1 2 3 or 4 5 or 6 and 7 or 8 following the 111-In-CMD-193 infusion Subjects were evaluated for safety for 3 hours post-infusion on Day 1 of each cycle with subsequent safety assessments performed on Days 8 and 15 Blood for human anti-human antibody HAHA response was collected pre-infusion prior to each subsequent cycle every 3 weeks and at study discontinuation
CMD-193 was administered on Day 1 of each subsequent 21-day cycle as a 60 5 minute intravenous IV infusion at a dose of 10 mgm2 in Cohort 1 and 26 mgm2 in Cohort 2 Each subject received up to 6 cycles of CMD-193 including the initial infusion of 111-In-CMD-193 until disease progression unacceptable toxicity or withdrawal of consent Up to 6 additional cycles of CMD-193 were permitted if approved by the Sponsor in subjects who tolerated CMD-193 treatment and had evidence of response Pretreatment medications eg paracetamol promethazine hydrochloride were to be administered to reduce the incidence and severity of an anticipated infusion syndrome characterized by fever and chills and less commonly hypotension
Restaging by computed tomography CT scan was performed at the end of Cycles 2 4 and 6 Assessment of tumor metabolism was performed by positron emission tomography with 18F-labeled fluorodeoxyglucose 18F-FDG-PET prior to Cycle 1 and at the time of restaging at the end of Cycles 2 and 4
CMD-193 was administered on Day 1 of each subsequent 21-day cycle as a 60 5 minute intravenous IV infusion at a dose of 10 mgm2 in Cohort 1 and 26 mgm2 in Cohort 2 Each subject received up to 6 cycles of CMD-193 including the initial infusion of 111-In-CMD-193 until disease progression unacceptable toxicity or withdrawal of consent Up to 6 additional cycles of CMD-193 were permitted if approved by the Sponsor in subjects who tolerated CMD-193 treatment and had evidence of response Pretreatment medications eg paracetamol promethazine hydrochloride were to be administered to reduce the incidence and severity of an anticipated infusion syndrome characterized by fever and chills and less commonly hypotension
Restaging by computed tomography CT scan was performed at the end of Cycles 2 4 and 6 Assessment of tumor metabolism was performed by positron emission tomography with 18F-labeled fluorodeoxyglucose 18F-FDG-PET prior to Cycle 1 and at the time of restaging at the end of Cycles 2 and 4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None