Drugs / Dovitinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | — | “concerning our New Drug Application (“NDA”) for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.” allarity.com ↗ “regarding our NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.” allarity.com ↗ “regarding FDA interactions on the Dovitinib NDA, which was submitted to the FDA in 2021” allarity.com ↗ |
Trials 39
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT05571969 | Mar 2023 → Feb 2024 | cancer | Allarity Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02048943 | Mar → Nov 2015 | pancreatic ductal adenocarcinoma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02268435 | Mar 2015 → Aug 2016 | gastrointestinal stromal tumor | Asan Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT01972750 | Oct 2013 → Nov 2016 | glioblastoma | PD Dr. Martin Glas | Unknown | No outcome recorded |
| Phase 1 | NCT01700270 | May 2013 → Aug 2014 | neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01680796 | Feb 2013 | plasma cell myeloma | University of Florida | Withdrawn | No outcome recorded |
| Phase 1 | NCT01515969 | Jul 2012 → Feb 2013 | non-small cell lung carcinoma | Heather Wakelee | Terminated | No outcome recorded |
| Phase 1 | NCT01548924 | Apr 2012 → Feb 2013 | cancer | Spanish National Cancer Research Centre | Terminated | No outcome recorded |
| Phase 1 | NCT01497392 | Mar 2012 → Aug 2015 | pancreatic adenocarcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01443481 | Nov 2011 → Oct 2014 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01714765 | Apr 2011 → Oct 2012 | clear cell renal carcinoma | Queen Mary University of London | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT01921673 | Aug 2013 → Jun 2016 | gastric cancer | Asan Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01484041 | Apr 2012 → Dec 2015 | breast cancer | Georgetown University | Terminated | No outcome recorded |
| Phase 1/2 | NCT00303251 | Apr 2006 → Sep 2009 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 223 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT02108782 | Oct 2014 → May 2015 | PPoma, gastrin-producing neuroendocrine tumor, glucagonoma, pancreatic endocrine carcinoma +2 | Academic and Community Cancer Research United | Withdrawn | No outcome recorded |
| Phase 2 | NCT01994590 | May 2014 → Jun 2017 | prostate cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT01888965 | Oct 2013 → Aug 2014 | colorectal cancer, malignant pancreatic neoplasm | Georgetown University | Terminated | No outcome recorded |
| Phase 2 | NCT01831726 | Aug 2013 → Dec 2015 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01861197 | Mar 2013 → Jan 2015 | non-small cell squamous lung carcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01769547 | Mar 2013 → Jun 2015 | malignant pleural mesothelioma | Ontario Clinical Oncology Group (OCOG) | Terminated | Met primary Stop: Enrollment |
| Phase 2 | NCT01732107 | Mar 2013 → Mar 2017 | urinary bladder cancer | Noah Hahn, M.D. | Terminated | No outcome recorded |
| Phase 2 | NCT01676714 | Feb 2013 → Jan 2016 | colorectal cancer, non-small cell lung carcinoma | University of California, Davis | Completed | No outcome recorded |
| Phase 2 | NCT01964144 | Jan 2013 → Oct 2014 | thyroid cancer | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT01753713 | Dec 2012 → Jan 2015 | adult glioblastoma, giant cell glioblastoma, gliosarcoma | Manmeet Ahluwalia, MD | Completed | No outcome recorded |
| Phase 2 | NCT01266070 | Nov 2012 → Dec 2015 | von Hippel-Lindau disease | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT01678105 | Nov 2012 → Sep 2015 | salivary gland adenoid cystic carcinoma | Ontario Clinical Oncology Group (OCOG) | Completed | No outcome recorded |
| Phase 2 | NCT01719549 | Sep 2012 → Feb 2016 | gastric cancer | Asan Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01635907 | Jun 2012 → Mar 2016 | paraganglioma, pheochromocytoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01528345 | Apr 2012 → Apr 2015 | breast cancer | Novartis Pharmaceuticals | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT01791387 | Mar 2012 → Jun 2015 | clear cell renal carcinoma | Auckland District Health Board | Unknown | No outcome recorded |
| Phase 2 | NCT01524692 | Mar 2012 → Jan 2014 | adenoid cystic carcinoma | University of Virginia | Completed | No outcome recorded |
| Phase 2 | NCT01262027 | Jan 2012 → Nov 2015 | breast cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01478373 | Jan 2012 → Jul 2014 | gastrointestinal stromal tumor | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01514526 | Jan 2012 → Jul 2013 | adrenal cortex carcinoma | Spanish Oncology Genito-Urinary Group | Completed | No outcome recorded |
| Phase 2 | NCT01440959 | Sep 2011 → Mar 2013 | gastrointestinal stromal tumor | Asan Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01232296 | Jul 2011 → Apr 2014 | hepatocellular carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02065323 | ? → Aug 2014 | prostate cancer | Oscar Goodman, Jr. | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02116803 | May 2014 → Nov 2016 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT01223027 | Mar 2011 → Jun 2014 | clear cell renal carcinoma | Novartis Pharmaceuticals | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT01496534 Comparator | Jan 2012 → Sep 2013 | urinary bladder cancer | Matthew Galsky | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-08-30 | Allarity Therapeutics | Results PLOS ONE Publishes Data on Allarity Therapeutics’ DRP® Companion Diagnostic for Dovitinib allarity.com ↗
Data showed that the DRP ® -Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients. |
| 2022-02-18 | Allarity Therapeutics | Regulatory Allarity Therapeutics Receives Refusal to File Letters from U.S. FDA allarity.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has provided the Company with Refusal to File (“RTF”) letters regarding the new drug application (“NDA”) for dovitinib |
| 2021-12-22 | Allarity Therapeutics | Regulatory Allarity Therapeutics Submits New Drug Application (NDA) to the U.S. FDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma (RCC) allarity.com ↗ |
| 2021-09-16 | Allarity Therapeutics | Results Allarity Therapeutics Presents Dovitinib Survival Data from DRP® Screened RCC Patients at ESMO 2021 Virtual Congress allarity.com ↗
When the DRP-Dovitinib score was increased to a score above 67%, the survival in the DRP ® -selected group increased to a median of 20.6 months (95% Confidence Interval 9.53-35.6, N=15). |
| 2021-03-09 | Allarity Therapeutics | Results Allarity Therapeutics Announces Positive Data from Preclinical Study of Dovitinib in Osteosarcoma allarity.com ↗
Treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib), increased the median survival time by 50 %. |
| 2019-04-30 | Allarity Therapeutics | Results Oncology Venture provides news on its clinical development projects dovitinib, 2X‑121 and LiPlaCis allarity.com ↗
New analyses of biopsies from clinical trial cohorts of liver and breast cancer patients resulted in equally good predictability. |
| 2019-02-07 | Allarity Therapeutics | Results Clinical update: Dovitinib DRP data mining successfully completed and new LiPlaCis data continues to support an FDA breakthrough designation strategy allarity.com ↗
This datamining has given a precision improvement, and there is now, in both cases, an even stronger identification by the DRP ® of the responders based on patient biopsy and gene expression data . |
All press releases naming this drug 24 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dovitinib | “Dovitinib (TKI258) is an orally available inhibitor of fibroblast growth factor (FGF), VEGF, and platelet-derived growth factor receptors.” PMID 21976540 ↗ Oct 201139“Dovitinib given orally on days 1-5, 8-12 and 15-19” NCT01496534 ↗ |
| Known as | dovitinib lactate | “To determine the maximum tolerated dose and recommended phase II dose of dovitinib (dovitinib lactate) when administered concurrently with gemcitabine (gemcitabine...” NCT02048943 ↗1“To characterize the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and dovitinib (dovitinib lactate), assessing for toxicity using the Common...” NCT01515969 ↗ |
| Known as | TKI258 | “A drug-drug interaction study to assess the effect of the CYP1A2 inhibitor fluvoxamine on the pharmacokinetics of dovitinib (TKI258) in patients with advanced solid tumors.” PMID 29101463 ↗ Nov 20176“Oral Dovitinib (TKI258) as a gelatin capsule of 100 mg strength and dosed on a flat scale of 500 mg on a 5 days on /2 days off dosing schedule.” NCT01478373 ↗ “Dovitinib (TKI258) is an orally available inhibitor of fibroblast growth factor (FGF), VEGF, and platelet-derived growth factor receptors.” PMID 21976540 ↗ Oct 2011 “Dovitinib (TKI258, Novartis) is a multi-kinase inhibitor.” NCT01440959 ↗ “DOVITINIB (TKI258)” NCT01548924 ↗ “Dovitinib (TKI258)” NCT01831726 ↗ “Dovitinib (TKI258)” NCT01524692 ↗ |
| Action | Inhibit | “Dovitinib (TKI258) is an orally available inhibitor of fibroblast growth factor (FGF), VEGF, and platelet-derived growth factor receptors.” PMID 21976540 ↗ Oct 2011 |
| Modality | Small molecule | “Dovitinib is an oral multitargeted kinase inhibitor with potent activity against receptors for vascular endothelial growth factor, platelet-derived growth factor, and basic...” PMID 23400739 ↗ Jan 2013 |
| Route | Oral | “received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule” NCT01223027 ↗ |
| Target | FGFR1 | “blocking constitutive signaling of the fibroblast growth factor receptor-1 (FGFR1)” NCT01524692 ↗ |