Recurrent Malignant Mesothelioma Clinical Trial
Official title:
A Phase 2 Study of ARQ 197 in Patients With Previously-Treated Malignant Mesothelioma
This phase II trial studies how well tivantinib works in treating patients with previously treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the objective response rate of patients with malignant mesothelioma who are
treated with ARQ 197 (tivantinib).
SECONDARY OBJECTIVES:
I. To determine the progression-free survival of patients with malignant mesothelioma who
are treated with ARQ 197.
II. To determine the toxicity experienced by patients with malignant mesothelioma who are
treated with ARQ 197.
III. To determine median and overall survival of patients with malignant mesothelioma who
are treated with ARQ 197.
TERTIARY OBJECTIVES:
I. To determine the frequency of mesenchymal-epithelial transition (MET) gene amplification
in malignant mesothelioma patient tumor samples, and to correlate the results with MET
immunohistochemistry (IHC).
II. To determine whether MET gene amplification results in increased sensitivity to ARQ 197
as observed by improved clinical outcomes (response rate [RR] and progression free survival
[PFS]) compared to those without MET gene over-expression/amplification.
III. To determine whether high baseline serum hepatocyte growth factor (HGF), as well as
changes in serum HGF during treatment at pre-defined early time points, correlate with
treatment efficacy and clinical outcome, as measured by response rate and progression-free
survival.
IV. To identify mutations by sequencing of specific areas of the MET gene in tumor samples
(semaphorin [SEMA], jumonji [JM] and tyrosine kinase domains).
V. To perform immunohistochemistry (IHC) of mesothelioma tumors for HGF, MET and
phosphorylated (p)-MET (pY1003 and pY1230/34/35).
VI. To assess serum HGF and serum soluble MET levels by enzyme linked immunosorbent assay
(ELISA) (R&D systems) pre-treatment, after 2 cycles and at disease progression.
OUTLINE:
Patients receive tivantinib orally (PO) twice daily (BID). Treatment continues in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00025207 -
Gefitinib in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
Completed |
NCT00107432 -
Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.
|
Phase 2 | |
Terminated |
NCT00028782 -
EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
|
N/A | |
Completed |
NCT00027703 -
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
Recruiting |
NCT04213794 -
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients
|
Early Phase 1 | |
Completed |
NCT01503177 -
Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
|
Phase 1 | |
Completed |
NCT00243074 -
S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT01126346 -
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
|
N/A | |
Completed |
NCT00039182 -
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
|
Phase 2 | |
Withdrawn |
NCT01325753 -
Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
|
N/A | |
Completed |
NCT00459862 -
Pazopanib in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
Active, not recruiting |
NCT01064648 -
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 1/Phase 2 | |
Completed |
NCT00365053 -
PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT00392444 -
Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
|
Phase 2 | |
Completed |
NCT00309946 -
Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT00030498 -
Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
|
Phase 1 | |
Recruiting |
NCT03420963 -
Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
Withdrawn |
NCT01105390 -
AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 |