Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Onzeald | — | 2018-01-08 | europa.eu ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01976143 | Feb 2014 → Jun 2016 | cancer of unknown primary site, metastatic neoplasm | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01991678 | Nov 2013 → May 2017 | — | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT02312622 | Aug 2015 → Sep 2018 | breast cancer, metastatic malignant neoplasm in the brain, non-small cell lung carcinoma, small cell lung carcinoma | Joel Neal | Completed | No outcome recorded |
| Phase 2 | NCT01876446 | Aug 2013 → Jul 2017 | small cell lung carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01773109 | Jan 2013 → Jan 2016 | non-small cell lung carcinoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01663012 | Jul 2012 → Feb 2015 | anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma | Lawrence Recht | Completed | No outcome recorded |
| Phase 2 | NCT01457118 | Oct 2011 → Aug 2017 | cancer | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00856375 | Dec 2008 → Jul 2014 | colorectal cancer | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00802945 | Oct 2008 → Oct 2011 | breast cancer | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00806156 | Oct 2008 → Oct 2012 | ovarian cancer | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02915744 | Nov 2016 → Jul 2020 | breast cancer, metastatic neoplasm | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01492101 | Dec 2011 → Apr 2016 | female breast carcinoma | Nektar Therapeutics | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT00598975 Comparator | Feb 2008 → May 2009 | colorectal cancer | Nektar Therapeutics | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etirinotecan Pegol | “Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine...” PMID 26482278 ↗ Oct 20158“The long-acting topoisomerase-1 inhibitor, etirinotecan pegol, was designed to preferentially accumulate in tumor tissue including brain metastases, providing sustained...” PMID 31074641 ↗ May 2019 “A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety” NCT01976143 ↗ “A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer” NCT01876446 ↗ “A Phase 2 Study of Etirinotecan Pegol (NKTR-102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)” NCT02312622 ↗ “Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study.” PMID 24095299 ↗ Oct 2013 “A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)” NCT01991678 ↗ |
| Known as | NKTR 102 | “Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine...” PMID 26482278 ↗ Oct 201510“Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study.” PMID 24095299 ↗ Oct 2013 “A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)” NCT01991678 ↗ “A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)” NCT01991678 ↗ “Etirinotecan pegol (NKTR-102)” NCT01773109 ↗ |
| Known as | Pegylated irinotecan | “This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients with small cell lung cancer that has returned after a period of improvement.” NCT01876446 ↗ |
| Action | Inhibit | “Etirinotecan pegol is a long-acting topoisomerase-I inhibitor designed to provide prolonged tumour-cell exposure to SN38, the active metabolite.” PMID 24095299 ↗ Oct 20131“DNA topoisomerase I inhibitor” CHEMBL3039558 ↗ |
| Modality | Other / unclassified | “NKTR-102 (Topoisomerase I Inhibitor Polymer Conjugate)” NCT00856375 ↗ |
| Route | Intravenous | “NKTR-102 was administered intravenously (IV)” NCT00598975 ↗ |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL3039558 ↗ |