A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers

NCT01447706 ↗

Phase 2 Completed 223 enrolled Merrimack Pharmaceuticals Sanofi · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone

Timeline

Start: 2011-10
Primary completion: 2013-09
Completion: 2015-06

Outcome

Missed primary endpoint

paper Median PFS in the unselected intent-to-treat population was 3.75 months with seribantumab plus paclitaxel compared with 3.68 months with paclitaxel alone (hazard ratio [HR], 1.027; 95% CI, 0.741 to 1.425; P = .864). PMID 27998236 ↗

paper The addition of seribantumab to paclitaxel did not result in improved PFS in unselected patients. PMID 27998236 ↗

Publications

Liu JF, Ray-Coquard I, Selle F, Poveda AM, Cibula D, Hirte H, Hilpert F, Raspagliesi F, Gladieff L, Harter P, Siena S, Del Campo JM, Tabah-Fisch I, Pearlberg J, Moyo V, Riahi K, Nering R, Kubasek W, Adiwijaya B, Czibere A, Naumann RW, Coleman RL, Vergote I, MacBeath G, Pujade-Lauraine E. Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer. J Clin Oncol. 2016 Dec 20;34(36):4345-4353. doi: 10.1200/JCO.2016.67.1891. Epub 2016 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Seribantumab	Monoclonal antibody	20 mg/kg	Intravenous