End of Treatment. The EOT visit will occur ≤30 days post-treatment discontinuation. After discontinuation of study treatment, patients will be followed for PFS approximately every 3 months after EOT visit until PD, death or initiation of the subsequent treatment (if a patient discontinues from the treatment due to reasons other than PD), and for survival every 3 months after end of treatment visit for 12 months or until withdrawal of consent, death, or the end of study (i.e., when the last patient in the study has been followed up on study treatment for at least 1 year or completed at least 6 months of survival follow-up period after their last dose of study treatment, has withdrawn consent, has died, or has been lost to follow-up, whichever occurs first). The duration of the study will be approximately 3 years.
End of Treatment. Subjects will receive therapy until independently-confirmed disease progression per irRECIST. In the absence of significant clinical deterioration requiring intervention, disease progression identified at Week 12 should be confirmed with a repeat scan ≥ 4 weeks later and the subject should continue treatment until independent confirmation of PD based on the confirmation scan. The End of Treatment visit will be completed within 14 days of independent confirmation of radiologic PD as assessed by irRECIST (§11.3) and prior to initiation of other anti-cancer therapy. • Complete PE, including xxxxx xxxxx (T, BP, RR, HR), ECOG performance status assessment and weight if not completed within the previous 14 days • Collect blood samples for the following analyses if not completed within the previous 14 days: — CBC — Serum chemistry • Collect urine for urinalysis if not completed within the previous 14 days • 12-lead ECG • Assess adverse events and update concomitant medications • Perform CT/MRI for subjects who have not had an imaging study within the previous 4 weeks
End of Treatment. Patients will continue to receive MIRV until they present with PD per RECIST 1.1, as assessed by study Investigator, unacceptable toxicity, withdraw consent, or death, whichever comes first, or until the Sponsor terminates the study. Study treatment and/or participation in the study may be discontinued at any time at the discretion of the Investigator. The following may be reasons for the Investigator to remove a patient from the study drug: • The patient suffers an intolerable AE • Noncompliance, including failure to appear at one or more study visits • The patient was erroneously included in the study The reason for treatment discontinuation must be captured in the clinical trial database. Any AEs experienced up to the point of discontinuation and 30 days thereafter must be documented. All serious adverse events (SAEs), and those AEs assessed by the Investigator as at least possibly related to study drug should continue to be followed until they resolve or stabilize, whichever comes first. Patients will continue to be followed for OS, after discontinuing study drug (Section 9.3.3).
End of Treatment visit: three days after the last NI-0501 infusion
End of Treatment. (Visit 17 or Withdrawal from Study) *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
End of Treatment. Visit 2 (Day 6) With the exception of the CFRSD-CRISS administration and the blood and sputum samples for gallium and iron levels, the other Visit 2 procedures can be performed in any order in relation to the stop of the study drug infusion.
1. If not already completed for the day, administer CFRSD-CRISS.
2. Review subject diary.
3. Collect and review CFRSD-CRISS from days 2-6.
4. Record any AEs.
5. Record changes to concomitant medications.
6. Record weight.
7. Perform abbreviated physical examination.
8. Perform and record xxxxx xxxxx.
9. Perform and record oximetry.
10. Perform and record spirometry.
11. Assess infusion of study drug and stop infusion.
12. If applicable, remove the midline catheter, PICC, or peripheral IV.
13. Collect urine for urinalysis.
14. Collect blood for laboratory tests (hematology and serum chemistry) and, within 10 minutes of the stop of the infusion, for gallium and iron levels.
15. Collect expectorated sputum for gallium and iron levels within 10 minutes of the stop of the infusion.
16. Collect returned study drug supplies and perform accountability
17. Instruct the subject to drink two liters of fluid per day through Day 8.
18. Dispense subject diary and remind subject to complete the diary through Day 8.
19. Schedule subject for Visit 3.
End of Treatment. Patients will continue to receive study drug until they present with PD per RECIST 1.1, as assessed by study Investigator, unacceptable toxicity, withdraw consent, or death, whichever comes first, or until the Sponsor terminates the study. Study treatment and/or participation in the study may be discontinued at any time at the discretion of the Investigator. The following may be reasons for the Investigator to remove a patient from the study drug: • The patient suffers an intolerable AE • Noncompliance, including failure to appear at one or more study visits • The patient was erroneously included in the study The reason for treatment discontinuation must be captured in the EOT electronic case report form (eCRF). Any AEs experienced up to the point of discontinuation and 30 days thereafter must be documented on the AE eCRF. All serious adverse events (SAEs), and those AEs assessed by the Investigator as at least possibly related to study drug should continue to be followed until they resolve or stabilize, whichever comes first. Patients will continue to be followed for PFS2 and OS, after discontinuing study drug (Section 10.3.3).
