Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT01228435
Status:
TERMINATED
Last Update Posted:
2017-12-04
First Post:
2010-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
IPI-504 in NSCLC Patients With ALK Translocations
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase II Study of IPI-204, A Novel Hsp90 Inhibitor in NSCLC Patients With ALK Translocations
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IPI-504 blocks a protein that is in cancer cells and is also in normal cells. This protein is called Heat Shock Protein-90 (Hsp90). Hsp90 helps protect certain other proteins from being destroyed by cells. These proteins can mutate to give off signals that allow cancer cells to keep growing. By blocking the function of Hsp90, we hope that the cancer cell will block the mutated protein and cause the cancer cells to die. This drug have been used in other research studies and in the laboratory and information from those other research studies suggests that thsi drug may help to treat lung cancer with ALK mutations. In this research study, we are looking to see what effects IPI-504 has in patients with lung cancer who have an ALK mutation.
Detailed Description:
* Participants will receive the study drug (IPI-504) twice weekly for two weeks followed by 10 days without study treatment. This 3-week period is called a cycle. Participants will receive a total of 4 doses per cycle. On the days the participant receives study drug, they will come to the clinic and be given the IPI-504 by being. Participants will continue to receive study drug for additional cycles as long as they are benefiting from it and do not experience any severe side effects.
* Participants will have CT scans to assess the size and location of their tumor. They may also have a PET scan or a combination of PET/CT scans. Imaging will be done at the beginning of treatment and every five to six weeks while on study to assess how the tumor is responding to IPI-504.
* The following tests and procedures will be done on the prior to the first dose of IPI-504: physical examination, vital signs, routine blood tests, EKGs, serum or urine pregnancy test (for women of child-bearing potential).
* After the first dose of IPI-504, the following tests and procedures will be done: EKGs, vital signs (pulse only).
* For all other visit days throughout the study, the following exams, tests and procedures will be done: physical examination, vital signs, blood tests, tumor imaging assessments, MRI of the brain (if applicable), review of medications and answer questions about any side effects or changes in health.
* After the final dose of study drug the following tests and procedures will be done within 30 days: physical examination, ECOG Performance status, blood tests, review of medications and answer questions about any side effects of changes in health.
* Participants will have CT scans to assess the size and location of their tumor. They may also have a PET scan or a combination of PET/CT scans. Imaging will be done at the beginning of treatment and every five to six weeks while on study to assess how the tumor is responding to IPI-504.
* The following tests and procedures will be done on the prior to the first dose of IPI-504: physical examination, vital signs, routine blood tests, EKGs, serum or urine pregnancy test (for women of child-bearing potential).
* After the first dose of IPI-504, the following tests and procedures will be done: EKGs, vital signs (pulse only).
* For all other visit days throughout the study, the following exams, tests and procedures will be done: physical examination, vital signs, blood tests, tumor imaging assessments, MRI of the brain (if applicable), review of medications and answer questions about any side effects or changes in health.
* After the final dose of study drug the following tests and procedures will be done within 30 days: physical examination, ECOG Performance status, blood tests, review of medications and answer questions about any side effects of changes in health.
Study Oversight
Has Oversight DMC:
True
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?: