Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Patients With HER2 Negative MBC
Description
CONTESSA TRIO is a 2-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane. In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with HER2 negative locally advanced or metastatic breast cancer (MBC) who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary endpoint for Cohort 2 is ORR.
Study Start Date
May, 01 2019
Estimated Completion Date
September 2023
Interventions
- Drug: Atezolizumab
- Drug: Nivolumab
- Drug: Pembrolizumab
- Drug: Tesetaxel
Study ID
Odonate Therapeutics, Inc. -- ODO-TE-B202
Status
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Error Details:
| struct | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Cause |
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| Detail | An exception occurred while invoking an event handler method from Application.cfc. The method name is: onRequest. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Message | Event handler exception. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RootCause |
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| StackTrace | coldfusion.runtime.EventHandlerException: Event handler exception. at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:309) at coldfusion.filter.ApplicationFilter.invoke(ApplicationFilter.java:470) at coldfusion.filter.RequestMonitorFilter.invoke(RequestMonitorFilter.java:42) at coldfusion.filter.MonitoringFilter.invoke(MonitoringFilter.java:40) at coldfusion.filter.PathFilter.invoke(PathFilter.java:153) at coldfusion.filter.ExceptionFilter.invoke(ExceptionFilter.java:94) at coldfusion.filter.BrowserDebugFilter.invoke(BrowserDebugFilter.java:78) at coldfusion.filter.ClientScopePersistenceFilter.invoke(ClientScopePersistenceFilter.java:28) at coldfusion.filter.BrowserFilter.invoke(BrowserFilter.java:38) at coldfusion.filter.NoCacheFilter.invoke(NoCacheFilter.java:58) at coldfusion.filter.GlobalsFilter.invoke(GlobalsFilter.java:38) at coldfusion.filter.DatasourceFilter.invoke(DatasourceFilter.java:22) at coldfusion.filter.CachingFilter.invoke(CachingFilter.java:62) at coldfusion.CfmServlet.service(CfmServlet.java:219) at coldfusion.bootstrap.BootstrapServlet.service(BootstrapServlet.java:89) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:303) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.monitor.event.MonitoringServletFilter.doFilter(MonitoringServletFilter.java:42) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.inspect.weinre.MobileDeviceDomInspectionFilter.doFilter(MobileDeviceDomInspectionFilter.java:57) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at org.apache.catalina.core.StandardWrapperValve.invoke(StandardWrapperValve.java:219) at org.apache.catalina.core.StandardContextValve.invoke(StandardContextValve.java:110) at org.apache.catalina.authenticator.AuthenticatorBase.invoke(AuthenticatorBase.java:494) at org.apache.catalina.core.StandardHostValve.invoke(StandardHostValve.java:169) at org.apache.catalina.valves.ErrorReportValve.invoke(ErrorReportValve.java:104) at org.apache.catalina.core.StandardEngineValve.invoke(StandardEngineValve.java:116) at org.apache.catalina.connector.CoyoteAdapter.service(CoyoteAdapter.java:458) at org.apache.coyote.ajp.AjpProcessor.process(AjpProcessor.java:196) at org.apache.coyote.AbstractProtocol$AbstractConnectionHandler.process(AbstractProtocol.java:637) at org.apache.tomcat.util.net.JIoEndpoint$SocketProcessor.run(JIoEndpoint.java:316) at java.util.concurrent.ThreadPoolExecutor.runWorker(Unknown Source) at java.util.concurrent.ThreadPoolExecutor$Worker.run(Unknown Source) at org.apache.tomcat.util.threads.TaskThread$WrappingRunnable.run(TaskThread.java:61) at java.lang.Thread.run(Unknown Source) Caused by: coldfusion.runtime.CFPage$InvalidDateException: Date value passed to date function DateDiff is unspecified or invalid. at coldfusion.runtime.CFPage.DateDiff(CFPage.java:1604) at cftrial2ddetails2ecfm1310202973.runPage(C:\inetpub\wwwroot\trial-details.cfm:187) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfindex2ecfm944125949._factor8(C:\inetpub\wwwroot\index.cfm:302) at cfindex2ecfm944125949.runPage(C:\inetpub\wwwroot\index.cfm:1) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfApplication2ecfc953308886$funcONREQUEST.runFunction(C:\inetpub\wwwroot\Application.cfc:147) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:487) at coldfusion.runtime.UDFMethod$ReturnTypeFilter.invoke(UDFMethod.java:420) at coldfusion.runtime.UDFMethod$ArgumentCollectionFilter.invoke(UDFMethod.java:383) at coldfusion.filter.FunctionAccessFilter.invoke(FunctionAccessFilter.java:95) at coldfusion.runtime.UDFMethod.runFilterChain(UDFMethod.java:334) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:231) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:646) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:435) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:405) at coldfusion.runtime.AppEventInvoker.invoke(AppEventInvoker.java:108) at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:301) ... 38 more | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Suppressed |
|
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| TagContext |
|
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| Type | Expression | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| name | onRequest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Session:
| struct | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| authorized | no | ||||||||||||
| cfid | 10908509 | ||||||||||||
| cftoken | f998ef3efe9997d8-CB1C0DA6-5056-B902-145A6BAD1FC5CE42 | ||||||||||||
| confirm_token | 0 | ||||||||||||
| confirmed_ind | 0 | ||||||||||||
| country | [empty string] | ||||||||||||
| [empty string] | |||||||||||||
| fname | [empty string] | ||||||||||||
| last_login | [empty string] | ||||||||||||
| lname | [empty string] | ||||||||||||
| locstruct |
|
||||||||||||
| opt_in_ind | 0 | ||||||||||||
| profession | [empty string] | ||||||||||||
| professiontblvar | REF_PROFESSION | ||||||||||||
| refspecialtytblvar | REF_SPECIALTY | ||||||||||||
| refspectblvar | REF_SPEC | ||||||||||||
| sessionid | CLINICALTRIALSLOCATOR_PROD_10908509_f998ef3efe9997d8-CB1C0DA6-5056-B902-145A6BAD1FC5CE42 | ||||||||||||
| spec_id | [empty string] | ||||||||||||
| sponsored_modal | 0 | ||||||||||||
| state_cd | [empty string] | ||||||||||||
| u_spec | [empty string] | ||||||||||||
| urltoken | CFID=10908509&CFTOKEN=f998ef3efe9997d8-CB1C0DA6-5056-B902-145A6BAD1FC5CE42 | ||||||||||||
| user_id | [empty string] | ||||||||||||
| user_type | [empty string] | ||||||||||||
| zip | [empty string] | ||||||||||||
Form:
| struct [empty] |
|---|
CGI:
| struct | |
|---|---|
| AUTH_PASSWORD | [empty string] |
| AUTH_TYPE | [empty string] |
| AUTH_USER | [empty string] |
| CERT_COOKIE | [empty string] |
| CERT_FLAGS | [empty string] |
| CERT_ISSUER | [empty string] |
| CERT_KEYSIZE | 256 |
| CERT_SECRETKEYSIZE | 4096 |
| CERT_SERIALNUMBER | [empty string] |
| CERT_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| CERT_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| CERT_SUBJECT | [empty string] |
| CF_TEMPLATE_PATH | C:\inetpub\wwwroot\index.cfm |
| CONTENT_LENGTH | 0 |
| CONTENT_TYPE | [empty string] |
| CONTEXT_PATH | [empty string] |
| GATEWAY_INTERFACE | CGI/1.1 |
| HTTPS | on |
| HTTPS_KEYSIZE | 256 |
| HTTPS_SECRETKEYSIZE | 4096 |
| HTTPS_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| HTTPS_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| HTTP_ACCEPT | text/html,application/xhtml+xml,application/xml;q=0.9,*/*;q=0.8 |
| HTTP_ACCEPT_ENCODING | br,gzip |
| HTTP_ACCEPT_LANGUAGE | en-US,en;q=0.5 |
| HTTP_CONNECTION | Keep-Alive |
| HTTP_COOKIE | [empty string] |
| HTTP_HOST | clinicaltrialslocator.com |
| HTTP_REFERER | [empty string] |
| HTTP_URL | [empty string] |
| HTTP_USER_AGENT | CCBot/2.0 (https://commoncrawl.org/faq/) |
| LOCAL_ADDR | www.clinicaltrialslocator.com |
| PATH_INFO | /index.cfm |
| PATH_TRANSLATED | C:\inetpub\wwwroot\index.cfm |
| QUERY_STRING | pg=trial-details&nct_id=NCT03952325&srch_radius=0&srch_zip=06828&srch_phase=&alpha_filter=A&actively_recruiting=Y&srch_condition= |
| REMOTE_ADDR | 3.237.67.179 |
| REMOTE_HOST | 3.237.67.179 |
| REMOTE_USER | [empty string] |
| REQUEST_METHOD | GET |
| SCRIPT_NAME | /index.cfm |
| SERVER_NAME | clinicaltrialslocator.com |
| SERVER_PORT | 443 |
| SERVER_PORT_SECURE | 1 |
| SERVER_PROTOCOL | HTTP/1.1 |
| SERVER_SOFTWARE | Microsoft-IIS/8.5 |
| WEB_SERVER_API | [empty string] |
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