Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01055522
Status:
TERMINATED
Last Update Posted:
2014-02-25
First Post:
2010-01-22
Brief Title:
Clinical Study Phase II of L19IL2 in Combination With Dacarbazine in Patients With Metastatic Melanoma
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
Dose Definition and Activity Evaluation Study of the Tumor-Targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Combination With Dacarbazine in Patients With Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
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:
This Phase II clinical study is an open-label multicenter study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma
The study is divided in two parts a phase IIa part designed to establish the recommended dose RD of L19IL2 when administered in combination with a fixed dose of Dacarbazine as well as to determine the preliminary tolerability profile the second phase IIb part evaluates the objective response rate ORR including a randomized study with a fixed dose of Dacarbazine with or without L19IL2 dosed at the RD determined in phase IIa
The study is divided in two parts a phase IIa part designed to establish the recommended dose RD of L19IL2 when administered in combination with a fixed dose of Dacarbazine as well as to determine the preliminary tolerability profile the second phase IIb part evaluates the objective response rate ORR including a randomized study with a fixed dose of Dacarbazine with or without L19IL2 dosed at the RD determined in phase IIa
Detailed Description:
Dose limiting toxicity will be assessed during the dose-escalation part of Phase IIa from day 1 through day 21 of the first cycle
Response will be measured using RECIST criteria every 6 weeks after every 2 cycles of treatment Patients with stable or responding disease at each assessment may receive additional treatment for a maximum of 6 cycles of induction Patients with stable or responding disease after induction may receive L19IL2 without dacarbazine every 2 weeks as maintenance therapy
Tumor expression of ED-B FN and tumor uptake of L19IL2 and of Dacarbazine will be assessed via immunohistochemistry andor other methods deemed appropriate on tumor tissue biopsies Tumor biopsy will be performed on superficial accessible cutaneous andor subcutaneous lesions only Tumor biopsy will be considered optional and will not preclude patient entry on to study should the patient refuse
Pharmacokinetics of L19IL2 Dacarbazine and AIC will be assessed from serial blood samples using standard methods
Overall response rate PFS survival rate at 6 and 12 months and overall survival time for all patients and separately for the patients in the Phase IIb part will be assessed using standard methods
Response will be measured using RECIST criteria every 6 weeks after every 2 cycles of treatment Patients with stable or responding disease at each assessment may receive additional treatment for a maximum of 6 cycles of induction Patients with stable or responding disease after induction may receive L19IL2 without dacarbazine every 2 weeks as maintenance therapy
Tumor expression of ED-B FN and tumor uptake of L19IL2 and of Dacarbazine will be assessed via immunohistochemistry andor other methods deemed appropriate on tumor tissue biopsies Tumor biopsy will be performed on superficial accessible cutaneous andor subcutaneous lesions only Tumor biopsy will be considered optional and will not preclude patient entry on to study should the patient refuse
Pharmacokinetics of L19IL2 Dacarbazine and AIC will be assessed from serial blood samples using standard methods
Overall response rate PFS survival rate at 6 and 12 months and overall survival time for all patients and separately for the patients in the Phase IIb part will be assessed using standard methods
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-005737-11 | EUDRACT_NUMBER | None | None |