A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Pe… (NCT02389985) | Clinical Trial Compass
TerminatedPhase 1/2
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: Company decision
United States30 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it completed — do you know why it was stopped, and does that affect what we can learn from any safety or effectiveness data it collected?
2Since this was a Phase 1/Phase 2 study combining CRLX101 (NLG207) with weekly paclitaxel, how much do we actually know about whether this combination is safe, given that Phase 1 trials are still in the early dose-finding stage?
3The trial was measuring dose-limiting toxicities as a primary goal — based on what was reported before it was terminated, are there specific side effects from this drug combination that I should be aware of when considering my options?
4For recurrent or persistent ovarian cancer like mine, would standard treatments — such as other approved chemotherapy combinations — be a better starting point before considering experimental approaches like this one?
5Are there other currently active clinical trials for recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer that might be worth exploring now that this one is no longer enrolling?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Number of Participants With Dose Limiting Toxicities (DLTs)
. 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.
Exclusion criteria
. Patients who have had previous treatment with:
. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin, are excluded if:
. 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.