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

Stopped early · Phase 1/Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT02389985

Run by

NewLink Genetics Corporation

People needed

30

Starts

2015-07-01

Expected to finish

2018-10-18

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
• Patient must have measurable disease or detectable (non-measurable) disease:
• Measurable disease will be defined by RECIST 1.1.
• Patients must have adequate bone marrow, renal, hepatic, and neurologic functions
• Patients should be free of active infection requiring parenteral antibiotics.
• Any other prior therapy directed at the malignant tumor, including chemotherapy, bevacizumab or other biologic or targeted agents and immunologic agents, must be discontinued at least 21 days (three weeks) prior to registration.
• Any prior radiation therapy must be discontinued at least four weeks prior to registration.
• Major surgery within 28 days (four weeks) prior to registration.
• Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease.
• Patients must have a GOG performance status of 0 or 1.
• Patients who will be enrolled under protocol amendment # 2 must have previously received bevacizumab, either discontinued due to intolerability, or progressed after at least 2 cycles of bevacizumab

You may not qualify if…

• Patients who have had previous treatment with:
• CRLX101 or with any topoisomerase I therapy;
• Weekly paclitaxel for recurrent or persistent disease.
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin, are excluded if:
• There is any evidence of other malignancy being present within the last three years;
• Previous cancer treatment contraindicates this protocol therapy.
• Patients with known active hepatitis or HIV.
• Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first dose of study drug.
• Patients with clinically significant cardiovascular disease.
• Patients with serous non-healing wound, ulcer, or bone fracture.
• Patients with active bleeding or pathologic conditions that carry high risk of bleeding
• Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition.
• Patients with active infection requiring parenteral antibiotics.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• The Ohio State University — Columbus, Ohio, United States
• University of Oklahoma / Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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