Male and female participants at least 18 years of age who are actively receiving treatment with pemigatinib under a parent protocol and receiving clinical benefit and who do not have access to pemigatinib outside of a clinical trial MedDRA version: 21.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864
Conditions
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Currently enrolled and receiving treatment in an Incyte-sponsored clinical study (parent protocol) of pemigatinib as monotherapy or combination therapy. 2. Currently benefiting from and tolerating treatment with pemigatinib, as determined by the investigator. 3. Demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. 4. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures. 5. Currently have no evidence of progressive disease, as determined by the investigator, following treatment with pemigatinib as monotherapy or combination therapy. 6. Willingness to avoid pregnancy or fathering children based on the criteria below. a. Male participants must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from signing of the ICF through 90 days after the last dose of pemigatinib and 6 months after the last dose of gemcitabine and/or cisplatin and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed. NOTE: Men being treated with gemcitabine must be advised to seek further advice regarding cryoconservation of sperm before treatment because of the possibility of infertility due to therapy with gemcitabine. b. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR = 12 months of amenorrhea) are eligible. c. Women of childbearing potential must have a negative serum pregnancy test at signing of the ICF and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from signing of the ICF through safety follow-up (30-35 days after the last dose of pemigatinib) and through 6 months after the last dose of gemcitabine and/or cisplatin. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed. 7. Written informed consent obtained prior to enrolling in the rollover study. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Able to access pemigatinib commercially or outside of a clinical trial. 2. Permanently discontinued from the parent protocol for any reason. 3. No longer meet the inclusion/exclusion criteria from the parent protocol if still receiving treatment. 4. Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study, starting with Day 1 of the rollover study visit through completion of safety follow-up or through 90 days from the date of last dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of pemigatinib.;Secondary Objective: ;Primary end point(s): Frequency and nature of AEs and SAEs as assessed by CTCAE v5.0.;Timepoint(s) of evaluation of this end point: The schedule for assessments will be performed according to the schedule of activities reported in the protocol. Participants should undergo disease assessments according to the institution's standard of care. Adverse events will be monitored from the time the participant signs the ICF until at least 30 days after the last dose of study treatment. | — |
Countries
Denmark, France, Italy, Japan, United States
Contacts
Public ContactClinical Trials Information
Incyte Corporation
Outcome results
None listed