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)

Korábbi kezelés

• 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.

Laborértékek

• 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.

• 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.