A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase 1/2 Terminated 30 enrolled NewLink Genetics Corporation

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to estimate the maximum tolerated doses (MTD) of CRLX101 when administered in combination with weekly paclitaxel in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer. Determine through pharmacokinetic evaluation(sometimes described as what the body does to a drug, refers to the movement of drug into, through and out of the body-the time and course of its absorption, bioavailability, distribution, metabolism, and excretion) whether or not the disposition of paclitaxel is affected by the concurrent administration of CRLX101.

Timeline

Start: 2015-07
Primary completion: 2018-06-04
Completion: 2018-10-18

Outcome

Missed primary endpoint

Stopped: “Company decision”

paper Although the observed ORR was not statistically better than the historical control rate PMID 33390325 ↗

Publications

Duska LR, Krasner CN, O'Malley DM, Hays JL, Modesitt SC, Mathews CA, Moore KN, Thaker PH, Miller A, Purdy C, Zamboni WC, Lucas AT, Supko JG, Schilder RJ. A phase Ib/II and pharmacokinetic study of EP0057 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Gynecol Oncol. 2021 Mar;160(3):688-695. doi: 10.1016/j.ygyno.2020.12.025. Epub 2020 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DAVAMOTECAN PEGADEXAMER	Other / unclassified	12 mg/kg	Intravenous
Subject	DAVAMOTECAN PEGADEXAMER	Other / unclassified	15 mg/kg	Intravenous
Subject	DAVAMOTECAN PEGADEXAMER	Other / unclassified	15 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous