Ovarian cancer combo trial halted early
NCT ID NCT02389985
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug, CRLX101, combined with standard chemotherapy (paclitaxel) in 30 women with ovarian cancer that came back or didn't go away. The goal was to find the safest dose and see if the combination helped shrink tumors. The trial was terminated early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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30 people
The number who actually took part.
- Start date
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Jul 2015
- Finished
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Oct 2018
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Patient must have measurable disease or detectable (non-measurable) disease: Measurable disease will be defined by RECIST 1.1. 3. Patients must have adequate bone marrow, renal, hepatic, and neurologic functions 4. Patients should be free of active infection requiring parenteral antibiotics. 5. 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. 6. Any prior radiation therapy must be discontinued at least four weeks prior to registration. 7. Major surgery within 28 days (four weeks) prior to registration. 8. Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease. 9. Patients must have a GOG performance status of 0 or 1. 10. 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 Exclusion Criteria: 1. Patients who have had previous treatment with: * CRLX101 or with any topoisomerase I therapy; * Weekly paclitaxel for recurrent or persistent disease. 2. 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. 3. Patients with known active hepatitis or HIV. 4. 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. 5. Patients with clinically significant cardiovascular disease. 6. Patients with serous non-healing wound, ulcer, or bone fracture. 7. Patients with active bleeding or pathologic conditions that carry high risk of bleeding 8. Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition. 9. Patients with active infection requiring parenteral antibiotics.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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The Ohio State University
Columbus, Ohio, 43210, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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University of Oklahoma / Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
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University of Virginia Health System
Charlottesville, Virginia, 22901, United States
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Washington University
St Louis, Missouri, 63110, United States
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Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02095, United States
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Other studies related to the condition(s) this trial covers.
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