A Study to Provide Expanded Access for the Treatment of Cancers with Rearranged During Transfection (RET) Activation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-005198
- Scottsdale/Phoenix, Arizona: 19-005198
NCT ID: NCT03906331
Sponsor Protocol Number: 17494
About this study
The purpose of this study is to provide expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diagnosis of cancer with RET activation, who are not eligible for an ongoing LOXO-292 clinical trial and are medically suitable for treatment with LOXO-292 .
Exclusion Criteria:
- Currently enrolled in an ongoing clinical study of LOXO-292 or another RET inhibitor.
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Given the nature and objectives of this EAP, in principle there are no reasons for the exclusion of protected patients. Nevertheless, inclusion of such patients will be dependent on the Investigator’s judgement. This will be related to the level of impairment, as assessed by the Investigator, and its foreseen impact on a patient’s ability to comply with the protocol. In case of inclusion of such patients, informed consent would need to be administered according to ICH GCP sections 1.37 and/or 4.8.12, as applicable.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Victor Bernet, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Nina Karlin, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available