Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00749346
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2008-09-08
Brief Title:
NovoTTF-100L in Combination With Pemetrexed Alimta for Advanced Non-small Cell Lung Cancer
Sponsor:
NovoCure Ltd
Organization:
NovoCure Ltd
Study Overview
Official Title:
An Open Label Pilot Study of NovoTTF-100L in Combination With Pemetrexed Alimta for Advanced Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2011-09
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:
An open-label phase I-II trial will be performed in 42 patients with pretreated locally advanced non-small cell lung cancer The trial is designed to estimate the efficacy and to determine safety of NovoTTF-100L treatment combined with Pemetrexed for advanced NSCLC patients Patients will receive standard Pemetrexed therapy at 500 mgm2 iv q3w for 3 cycles concomitant to NovoTTF-100L therapy 12 hours a day daily until the end of all three cycles of Alimta Repeat treatments with Alimta NovoTTF-100L will be offered as long as the patient is stable or responding If there is a in-field response with progression outside of the NovoTTF field Pemetrexed is to be stopped and third line chemotherapy with Docetaxel is to be initiated 35 mgm2 weekly d1 8 15 q 28 d
Detailed Description:
The trial will be conducted in two stages Fourteen patients will be recruited to a phase I stage of the trial After all 14 patients have received 3 courses of Alimta 9 weeks of NovoTTF-100L treatment these patients will be analyzed for toxicity If the incidence of device related serious adverse events is 20 the trial will continue to the second stage where 42 patients will be assessed for safety and efficacy as part of a phase II study including the first 14 patients in the phase I study
Efficacy will be assessed based on local disease control in the lungs and liver time to systemic disease progression and overall survival Patients will be followed for at least 6 months after the last course of NovoTTF-100L is applied to assess survival
Efficacy will be assessed based on local disease control in the lungs and liver time to systemic disease progression and overall survival Patients will be followed for at least 6 months after the last course of NovoTTF-100L is applied to assess survival
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