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Ovarian cancer combo trial halted early

NCT ID NCT02389985

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Start date

Jul 2015

Finished

Oct 2018

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Oklahoma / Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22901, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02095, United States

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