Ignite Creation Date:
2024-05-06 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03531840
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2018-05-18
Brief Title:
Olaparib in People With Malignant Mesothelioma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Study of Olaparib in Subjects With Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Background
The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid DNA It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer BRCA gene It has not been approved for treating mesothelioma But some people with mesothelioma have mutations in a gene BRCA1 Associated Protein 1 BAP1 related to BRCA Researchers want to see if olaparib can work in patients with mutations in this gene They also want to see if works on mutations in other genes or patients without any mutations They want to see if olaparib causes mesothelioma tumors to shrink
Objective
To study the effect of olaparib on mesothelioma
Eligibility
People ages 18 and older with malignant mesothelioma that has already been treated
Design
Participants will be screened with
Sample of tumor tissue or fluid
Medical history
Physical exam
Blood heart and urine tests
Scans and x-rays
Participants will give blood and tissue samples These will be genetically tested
The study will be done in 21-day cycles
Participants will take tables of the study drug 2 times each day They will get information on what food and drugs to avoid during the study They will get information about birth control They will keep a diary of doses and symptoms
Participants will have blood and urine tests and scans every few weeks
Participants will be told any important genetic testing results
Participants will stay in the study until their disease gets worse or the participant or their doctor chooses to stop it
About 30 days after stopping the study drug participants will have a follow-up visit They will have a medical history physical exam blood tests and scans
Some participants will continue to have scans every 6 weeks
The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid DNA It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer BRCA gene It has not been approved for treating mesothelioma But some people with mesothelioma have mutations in a gene BRCA1 Associated Protein 1 BAP1 related to BRCA Researchers want to see if olaparib can work in patients with mutations in this gene They also want to see if works on mutations in other genes or patients without any mutations They want to see if olaparib causes mesothelioma tumors to shrink
Objective
To study the effect of olaparib on mesothelioma
Eligibility
People ages 18 and older with malignant mesothelioma that has already been treated
Design
Participants will be screened with
Sample of tumor tissue or fluid
Medical history
Physical exam
Blood heart and urine tests
Scans and x-rays
Participants will give blood and tissue samples These will be genetically tested
The study will be done in 21-day cycles
Participants will take tables of the study drug 2 times each day They will get information on what food and drugs to avoid during the study They will get information about birth control They will keep a diary of doses and symptoms
Participants will have blood and urine tests and scans every few weeks
Participants will be told any important genetic testing results
Participants will stay in the study until their disease gets worse or the participant or their doctor chooses to stop it
About 30 days after stopping the study drug participants will have a follow-up visit They will have a medical history physical exam blood tests and scans
Some participants will continue to have scans every 6 weeks
Detailed Description:
Background
Malignant mesothelioma is an invasive and often fatal neoplasm that arises from mesothelium that lines several organs
Recent studies have identified germline mutations in the gene encoding breast cancer type 1 BRCA1 associated protein-1 BAP1 which can predispose to mesothelioma
In addition to mesothelioma germline BAP1 mutations confer increased susceptibility for the development of several other tumors including uveal melanoma cutaneous melanoma renal cell cancers and possibly other cancers
In addition to BAP1 we found several novel germline variants that have previously not been associated with risk of developing mesothelioma
As evidenced by recent data derived from ovarian and prostate cancer patients mutations in deoxyribonucleic acid DNA repair genes can define subgroups of cancer patients with distinct vulnerabilities to DNA damage response inhibitors
Olaparib is a Poly ADP-ribose polymerase PARP inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated
Both established and patient derived mesothelioma cell lines with mutated DNA repair genes are sensitive to olaparib
Objective
-Determine the efficacy with respect to objective response rate of olaparib in patients with malignant mesothelioma based on somatic or germline mutation status of DNA repair genes
Eligibility
Patients must have progressive histologically or cytologically confirmed malignant mesothelioma
Age greater than or equal to 18 years
Patients must have received prior platinum and pemetrexed based therapies
Adequate organ and bone marrow function
Design
This is a phase II single center study of olaparib in subjects with malignant mesothelioma
All subjects will take olaparib by mouth twice daily until disease progression or intolerable side effects
Subjects will be assessed for safety continuously and efficacy every 6 weeks
Subjects will be analyzed in 3 separate comparison groups according to their mutation status
Comparison Group 1 Patients with a germline mutation in DNA repair genes
Comparison Group 2 Patients with BAP1 somatic mutations
Comparison Group 3 Patients with neither germline mutations nor BAP 1 somatic mutations
Up to 30 evaluable subjects will be enrolled
Malignant mesothelioma is an invasive and often fatal neoplasm that arises from mesothelium that lines several organs
Recent studies have identified germline mutations in the gene encoding breast cancer type 1 BRCA1 associated protein-1 BAP1 which can predispose to mesothelioma
In addition to mesothelioma germline BAP1 mutations confer increased susceptibility for the development of several other tumors including uveal melanoma cutaneous melanoma renal cell cancers and possibly other cancers
In addition to BAP1 we found several novel germline variants that have previously not been associated with risk of developing mesothelioma
As evidenced by recent data derived from ovarian and prostate cancer patients mutations in deoxyribonucleic acid DNA repair genes can define subgroups of cancer patients with distinct vulnerabilities to DNA damage response inhibitors
Olaparib is a Poly ADP-ribose polymerase PARP inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated
Both established and patient derived mesothelioma cell lines with mutated DNA repair genes are sensitive to olaparib
Objective
-Determine the efficacy with respect to objective response rate of olaparib in patients with malignant mesothelioma based on somatic or germline mutation status of DNA repair genes
Eligibility
Patients must have progressive histologically or cytologically confirmed malignant mesothelioma
Age greater than or equal to 18 years
Patients must have received prior platinum and pemetrexed based therapies
Adequate organ and bone marrow function
Design
This is a phase II single center study of olaparib in subjects with malignant mesothelioma
All subjects will take olaparib by mouth twice daily until disease progression or intolerable side effects
Subjects will be assessed for safety continuously and efficacy every 6 weeks
Subjects will be analyzed in 3 separate comparison groups according to their mutation status
Comparison Group 1 Patients with a germline mutation in DNA repair genes
Comparison Group 2 Patients with BAP1 somatic mutations
Comparison Group 3 Patients with neither germline mutations nor BAP 1 somatic mutations
Up to 30 evaluable subjects will be enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
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 |
|---|---|---|---|
| 18-C-0097 | None | None | None |