- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03052569
Expanded Access to RXDX-105 for Cancers With RET Alterations
April 24, 2019 updated by: Hoffmann-La Roche
Expanded Access to RXDX-105 for the Treatment of Cancers With RET Alterations
Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations who have not received TKIs that target RET alterations, who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92121
- Www.Ignyta.Com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of advanced cancer with RET alterations
- Unable to participate in an ongoing RXDX-105 clinical trial
- Willing and able to provide written, signed informed consent
- Medically suitable for treatment with RXDX-105
Exclusion Criteria:
- Prior treatment with a TKI that has activity against RET alterations
- Currently enrolled in an ongoing clinical study with any other investigational agent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 10, 2017
First Submitted That Met QC Criteria
February 10, 2017
First Posted (ACTUAL)
February 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RXDX-105 - EAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancers With RET Alterations
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Deciphera Pharmaceuticals LLCTerminatedMetastatic Solid Tumors | Locally Advanced Tumors | Cancers With MET Genomic Alterations | Cancers With TRK Genomic AlterationsUnited States
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Janssen Scientific Affairs, LLCApproved for marketingAdvanced Cancers and FGFR Genetic Alterations
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KinoTeck Therapeutics Co., LtdNot yet recruitingSolid Tumors with FGFR2 Alterations, Adult
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3H (Suzhou) Pharmaceuticals Co., Ltd.Not yet recruitingSolid Tumors With FGFR2 Alterations, AdultUnited States
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Novartis PharmaceuticalsCompleted
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3H (Suzhou) Pharmaceuticals Co., Ltd.RecruitingSolid Tumors With FGFR2 Alterations, AdultChina
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Taiho Oncology, Inc.TerminatedAdvanced or Metastatic Solid Tumors Irrespective of Gene Alterations | Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating MutationsUnited States, United Kingdom, Austria, France
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Harpoon TherapeuticsCompletedAdvanced Cancers Associated With Mesothelin ExpressionUnited States
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Hoffmann-La RocheNo longer availableCancers With NTRK, ROS1, or ALK Gene FusionsUnited States
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British Columbia Cancer AgencyBC Cancer FoundationRecruitingAdvanced Cancers | Metastatic Cancers | Cancers That Cannot be Treated With Curative IntentCanada
Clinical Trials on RXDX-105
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Memorial Sloan Kettering Cancer CenterCompletedOvarian Cancer | Non Small Cell Lung Cancer | RET Gene Mutation | BRAF Gene MutationUnited States
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Hoffmann-La RocheCompletedStudy of RXDX-105, Potent RET Inhibitor in Patients With Advanced Lung Cancer and Other Solid TumorsSolid TumorsUnited States
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Hoffmann-La RocheTerminated
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Hoffmann-La RocheTerminatedAdvanced or Metastatic Solid TumorsUnited States
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Beijing InnoCare Pharma Tech Co., Ltd.Completed
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AegisCN LLCDuke Clinical Research Institute; PharPoint Research, Inc.CompletedIntracerebral HemorrhageUnited States
-
Draeger Medical Systems, Inc.CompletedHyperbilirubinemia | Neonatal JaundiceCanada
-
Noema Pharma AGCompletedChildhood-Onset Fluency DisorderUnited States, Australia
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Therapeutics, Inc.CompletedScalp PsoriasisUnited States