Ignite Creation Date:
2024-05-06 @ 2:22 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02034981
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2013-10-16
Brief Title:
Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK MET or ROS1
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
AcSé CRIZOTINIB Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug
Status:
COMPLETED
Status Verified Date:
2024-02
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:
AcSé
Brief Summary:
This is a biology driven trans-tumoral multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes A cohort is defined by a pathology and a crizotinib-target alteration eg gastric cancer with MET amplification
For each cohort a two-stage design will be implemented In the situation where expected accrual allows for a sufficient number of patients to be accrued the alpha and beta errors will be fixed at 10 However in very rare diseases such as inflammatory myofibroblastic tumor IMT neuroblastoma glioblastoma and rhabdomyosarcoma RMS it is anticipated that the target number may not be achievable in a reasonable timeframe for these cohorts the alpha and beta errors will be fixed at 15 Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence
For each cohort a two-stage design will be implemented In the situation where expected accrual allows for a sufficient number of patients to be accrued the alpha and beta errors will be fixed at 10 However in very rare diseases such as inflammatory myofibroblastic tumor IMT neuroblastoma glioblastoma and rhabdomyosarcoma RMS it is anticipated that the target number may not be achievable in a reasonable timeframe for these cohorts the alpha and beta errors will be fixed at 15 Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence
Detailed Description:
Twenty cohorts are identified a cohort being defined as one pathology one target alteration such as gastric cancer with MET amplification 6
One cohort will be dedicated to miscellaneous very rare pediatric diseases identified through INCa platforms or pan-genome programs eg MOSKIDO IGR and will recruit up to 10 patients
Two cohorts will be dedicated to a couple of diseases harbouring at least one specific alteration in one crizotinib target same or different from those listed above eg in AXL gene arising from pan-genome trials
1 ALCL adults and children ALK-translocated
2 Colorectal cancer adults ALK-translocated
3 Colorectal cancer adults MET amplified
4 Colorectal cancer adults MET mutated
5 NSCLC adults MET amplified
6 NSCLC adults ROS1-translocated
7 Breast cancer adults ALK-translocated
8 Gastric cancer adults MET amplified
9 Cholangiocarcinoma adults ROS1-translocated
10 Ovarian cancer adults MET amplified
11 Clear cell renal cell carcinoma adults ALK-translocated
12 Clear cell renal cell carcinoma adults ALK-amplified
13 Papillary renal cell carcinoma adults MET mutated MET amplified
14 Hepatocarcinoma adults MET amplified
15 Neuroblastoma adults and children ALK-amplified ALK mutated
16 IMT adults and children ALK-translocated
17 Rhabdomyosarcoma alveolar and embryonal adults and children ALK-amplified
18 Glioblastoma adults MET amplified This cohort will only be open after amendment
19 Anaplastic thyroid cancer adults ALK mutated
20 Thyroid cancer follicular medullary papillary adults MET mutated
21 Miscellaneous rare pediatric diseases associated to at least one specific alteration in one crizotinib target same or different from those listed above
22 One another pathology associated to at least one specific alteration in one crizotinib target same or different from those listed above
23 One another pathology associated to at least one specific alteration in one crizotinib target same or different from those listed above
One cohort will be dedicated to miscellaneous very rare pediatric diseases identified through INCa platforms or pan-genome programs eg MOSKIDO IGR and will recruit up to 10 patients
Two cohorts will be dedicated to a couple of diseases harbouring at least one specific alteration in one crizotinib target same or different from those listed above eg in AXL gene arising from pan-genome trials
1 ALCL adults and children ALK-translocated
2 Colorectal cancer adults ALK-translocated
3 Colorectal cancer adults MET amplified
4 Colorectal cancer adults MET mutated
5 NSCLC adults MET amplified
6 NSCLC adults ROS1-translocated
7 Breast cancer adults ALK-translocated
8 Gastric cancer adults MET amplified
9 Cholangiocarcinoma adults ROS1-translocated
10 Ovarian cancer adults MET amplified
11 Clear cell renal cell carcinoma adults ALK-translocated
12 Clear cell renal cell carcinoma adults ALK-amplified
13 Papillary renal cell carcinoma adults MET mutated MET amplified
14 Hepatocarcinoma adults MET amplified
15 Neuroblastoma adults and children ALK-amplified ALK mutated
16 IMT adults and children ALK-translocated
17 Rhabdomyosarcoma alveolar and embryonal adults and children ALK-amplified
18 Glioblastoma adults MET amplified This cohort will only be open after amendment
19 Anaplastic thyroid cancer adults ALK mutated
20 Thyroid cancer follicular medullary papillary adults MET mutated
21 Miscellaneous rare pediatric diseases associated to at least one specific alteration in one crizotinib target same or different from those listed above
22 One another pathology associated to at least one specific alteration in one crizotinib target same or different from those listed above
23 One another pathology associated to at least one specific alteration in one crizotinib target same or different from those listed above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-000885-13 | EUDRACT_NUMBER | None | None |