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A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201)
EU CTIS ID: 2023-507678-42-00
What this study is testing
To provide access to selpercatinib for patients with locally advanced or metastatic solid tumors with activating RET alterations who are 18 years of age or older
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient is diagnosed with a locally advanced or metastatic tumor with evidence of qualifying/activating RET gene alteration who: - is not eligible for an ongoing selpercatinib clinical trial (for example, for clinical, geographic or financial reasons or due to cohort closure), but are deemed appropriate candidates to receive selpercatinib treatment by the treating physician and the Sponsor, and - Has progressed on, are intolerant to standard therapy, or no standard therapy exists -For regions where drug has become regulatory approved, local labeling language should be followed
- Eighteen years of age or older at the time of consent.
- Adequate hematologic, renal and hepatic function as defined in Section 5.1.
- Ability to provide consent by patient or legally authorized representative.
- Provision of a signed informed consent prior to any protocol specific procedures.
- Willingness of men and women of childbearing potential to observe double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 3 months following the last dose of treatment.
You likely can't join if
- Major surgery within 14 days prior to C1D1
- Investigational agent (via clinical trial) or anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of selpercatinib unless considered by the treating physician to be safe, within the best interest of the patient and with prior Sponsor approval.
- Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of treatment or prolongation of the QT interval corrected for heart rate using ec on more than 1 ECG obtained during the baseline period. Note: Patients who meet this criteria may be enrolled (with a modified dosing strategy) if a clinical rationale exists which is reviewed and agreed upon by the Sponsor. Patients with implanted pacemakers may enter the program without meeting corrected QT interval (QTc) criteria due to non-evaluable measurement.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Singapore
- Australia
- Japan
- Israel
- New Zealand
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Singapore; Australia; Japan; Israel; New Zealand and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.