M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
Summary
People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Blood thinners have been shown in prior animal and human studies to have anti-cancer effects. Necuparanib has been re-engineered from heparin to have much lower blood thinning activity while keeping the anti-tumor activity. The investigators are testing whether necuparanib administered in combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and gemcitabine.
Timeline
- Start
- 2012-05
- Primary completion
- 2016-10-24
- Completion
- 2016-10-24
Outcome
Missed primary endpoint
Stopped: “The study was terminated after a pre-planned futility analyses showed an insufficient level of efficacy in the study population to warrant continuation.”
paper The addition of necuparanib to standard of care treatment for advanced PDAC did not improve OS. PMID 32361265 ↗
Publications
- O'Reilly EM, Barone D, Mahalingam D, Bekaii-Saab T, Shao SH, Wolf J, Rosano M, Krause S, Richards DA, Yu KH, Roach JM, Flaherty KT, Ryan DP. Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma. Eur J Cancer. 2020 Jun;132:112-121. doi: 10.1016/j.ejca.2020.03.005. Epub 2020 Apr 28.
- O'Reilly EM, Roach J, Miller P, Yu KH, Tjan C, Rosano M, Krause S, Avery W, Wolf J, Flaherty K, Nix D, Ryan DP. Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Necuparanib Combined with Nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer: Phase I Results. Oncologist. 2017 Dec;22(12):1429-e139. doi: 10.1634/theoncologist.2017-0472. Epub 2017 Nov 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Necuparanib | Other / unclassified | 0.5 mg/kg | Subcutaneous |
| Subject | Necuparanib | Other / unclassified | 1 mg/kg | Subcutaneous |
| Subject | Necuparanib | Other / unclassified | 2 mg/kg | Subcutaneous |
| Subject | Necuparanib | Other / unclassified | 4 mg/kg | Subcutaneous |
| Subject | Necuparanib | Other / unclassified | 5 mg/kg | Subcutaneous |
| Subject | Necuparanib | Other / unclassified | 6 mg/kg | Subcutaneous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Background | Nab-paclitaxel | Small molecule | 125 mg/m2 | — |