Drugs / Ficlatuzumab
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT03316599 | Jan 2018 → Oct 2020 | pancreatic ductal adenocarcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02277184 | Sep 2015 → Sep 2016 | head and neck squamous cell carcinoma | Julie E. Bauman, MD, MPH | Terminated | No outcome recorded |
| Phase 1 | NCT02277197 | Aug 2015 → Jun 2016 | head and neck squamous cell carcinoma | James J Lee | Completed | No outcome recorded |
| Phase 1 | NCT02109627 | May 2015 → Dec 2019 | acute myeloid leukemia | C. Babis Andreadis | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01189513 | Aug 2010 → Jan 2011 | glioblastoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT00969410 | Aug 2009 → Mar 2011 | cancer | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00725634 | Sep 2008 → Dec 2010 | plasma cell myeloma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT01039948 | Dec 2009 → Aug 2013 | non-small cell lung carcinoma | AVEO Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT04100330 | Jan → Mar 2020 | acute myeloid leukemia | AVEO Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT03422536 | Dec 2017 → Mar 2022 | basaloid carcinoma, cancer of unknown primary site, lip and oral cavity squamous cell carcinoma, nasal cavity and paranasal sinus squamous cell carcinoma +2 | University of Arizona | Completed | Met primary |
| Phase 2 | NCT02318368 | Nov 2014 → Jan 2017 | non-small cell lung carcinoma | AVEO Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03013998 | Nov 2016 → Dec 2032 expected | acute myeloid leukemia | Beat AML, LLC | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06064877 | Jan 2024 → Aug 2027 expected | head and neck squamous cell carcinoma | AVEO Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02090127 | — | malignant mixed neoplasm | AVEO Pharmaceuticals, Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2021-09-20 | AVEO Pharmaceuticals, Inc. | Regulatory AVEO Oncology Announces Ficlatuzumab Granted Fast Track Designation by the U.S. FDA for the Treatment of Relapsed or Recurrent Head and Neck Squamous Cell Carcinoma aveooncology.com ↗
AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC). |
| 2021-05-19 | AVEO Pharmaceuticals, Inc. | Results AVEO Oncology Announces Positive Results from Randomized Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in Pan-Refractory, Metastatic HNSCC aveooncology.com ↗ |
| 2020-01-27 | AVEO Pharmaceuticals, Inc. | Results AVEO Oncology and Biodesix Announce Results from Phase 1b Study of Ficlatuzumab, Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer aveooncology.com ↗
The combination was associated with a promising durable response rate relative to expectations for gemcitabine and nab-paclitaxel alone. |
| 2019-04-01 | AVEO Pharmaceuticals, Inc. | Results AVEO and Biodesix Announce Positive Results from Phase Ib Ficlatuzumab-Cytarabine Trial in Patients with Relapsed and Refractory AML aveooncology.com ↗
AVEO Oncology (NASDAQ:AVEO) and Biodesix, Inc. today announced results from an investigator-sponsored Phase Ib expansion cohort of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML). |
| 2017-06-05 | AVEO Pharmaceuticals, Inc. | Results AVEO Oncology and Biodesix Announce Results from Two Investigator-Sponsored Phase 1 Studies of HGF Targeted Antibody Ficlatuzumab at the 2017 ASCO Annual Meeting aveooncology.com ↗ |
| 2014-09-29 | AVEO Pharmaceuticals, Inc. | Results AVEO and Biodesix Announce Exploratory Analysis of VeriStrat-Selected Patients with Non-Small Cell Lung Cancer in Phase 2 Study of Ficlatuzumab Presented at ESMO 2014 Congress aveooncology.com ↗
The results, presented in a poster session (abstract #8195) at the 2014 Congress of the European Society for Medical Oncology (ESMO), suggest that VeriStrat may be selective of positive clinical response for ficlatuzumab plus gefitinib over gefitinib alone. |
| 2012-10-01 | AVEO Pharmaceuticals, Inc. | Results AVEO Announces Detailed Results of Exploratory Phase 2 Study Evaluating Ficlatuzumab in First-Line Patients with Advanced Non-small Cell Lung Cancer; New Data Presented at ESMO aveooncology.com ↗
As previously reported, the study did not achieve its primary endpoint; however, the results presented at ESMO suggest that the addition of ficlatuzumab to gefitinib may be effective in select subsets of patients. |
| 2012-05-02 | AVEO Pharmaceuticals, Inc. | Results AVEO Announces Preliminary Results of Exploratory Phase 2 Study Evaluating HGF Inhibitor in First-Line Patients with Advanced Lung Cancer aveooncology.com ↗
In this study, encouraging signals of activity were observed in unique subsets of patients based on EGFR mutation status and c-Met expression level. |
| 2011-06-02 | AVEO Pharmaceuticals, Inc. | Results AVEO’s Ficlatuzumab in Combination with Gefitinib Well Tolerated in Patients with Non-Small Cell Lung Cancer; Phase 1b Data Presented at ASCO aveooncology.com ↗
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced results from the Phase 1b portion of its Phase 1b/2 clinical study of ficlatuzumab in combination with gefitinib (Iressa(TM)) in Asian subjects with non-small cell lung cancer (NSCLC). |
All press releases naming this drug 30 releases
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 | Ficlatuzumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02318368 ↗ |
| Known as | AV-299 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01039948 ↗ |
| Known as | SCH 900105 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01189513 ↗ |
| Action | Inhibit | “HGF inhibitory monoclonal antibody” PMID 29346833 ↗ Jan 2018 |
| Modality | Monoclonal antibody | “AV-299 is a humanized anti-HGF IgG1 monoclonal antibody” NCT01039948 ↗ |
| Route | Intravenous | “AV-299 monotherapy will be given as intravenous infusion” NCT00725634 ↗ |
| Target | HGF | “directed against free HGF” NCT01039948 ↗ |