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Ovarian CancerPhase 1/2NCT02389985

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

A Phase 1/2 study testing CRLX101 and Paclitaxel in people with Ovarian Cancer, run by NewLink Genetics Corporation at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
CRLX101 and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
7 sitesUnited States
Study dates
Jul 2015to 18 Oct 2018
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Virginia Health System

    Charlottesville, Virginia, 22901

  • The Ohio State University

    Columbus, Ohio, 43210

  • University of Oklahoma / Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02095

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase Ib/II Study of CRLX101 in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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.

Read the detailed description

Recurrent ovarian cancer represents a therapeutic challenge. Patients with resistant disease, showing progression within six months of platinum-containing therapy, have a poor prognosis, with median overall survival (OS) approximately 12 months.Ultimately most patients with recurrent disease ultimately develop platinum resistance, and novel strategies are needed.

In this setting the most active agents are pegylated liposomal doxorubicin (PLD), paclitaxel and topotecan. Multiple trials have demonstrated that combination therapy produces increased toxicity without improved efficacy.

This study proposes to examine the combination of CRLX101 in combination with weekly paclitaxel. Preclinical studies show synergistic activity in the SKOV3 human ovarian cancer xenograft ovarian cancer cell lines (14), as well as in vivo (15,16), perhaps via an antiangiogenic mechanism.

Conditions
Ovarian Cancer
Being tested
CRLX101, Paclitaxel
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRLX101Drug

    Also called NLG207

  • PaclitaxelDrug

    Also called Taxol

Study groups in NCT02389985
Study groupRoleWhat they receive
Dose Level 1Experimental12mg/kg CRLX101 and weekly paclitaxel administered by IV on days 1 and 15 of a 28 day cycle. Paclitaxel only is administered by IV on day 8.
Receives: Drug: CRLX101; Drug: Paclitaxel
Dose Level 2Experimental15mg/kg CRLX101 and weekly paclitaxel administered by IV on days 1 and 15 of a 28 day cycle. Paclitaxel only is administered by IV on day 8.
Receives: Drug: CRLX101; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Number of Participants With Dose Limiting Toxicities (DLTs)

    Number of subjects with DLTs

    Measured: 6 months

  2. Overall Response Rate

    Assessed using RECIST v1.0

    Measured: 1 year

Secondary outcomes (3)

  1. Progression Free Survival (PFS)

    Assessed using RECIST v1.1

    Measured: Through Month 6

  2. Duration of Response

    Assessed using RECIST 1.1

    Measured: 1 year

  3. Response Rate

    Assessed using RECIST v1.1

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion4 Jun 2018
  4. Study completion18 Oct 2018

Why it stopped: Company decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02389985
Sponsor's protocol ID
CRLX101-209
Status last verified
May 2026
First submitted
2 Mar 2015
Last updated
18 Jun 2026
Data monitoring committee
No

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.

    PubMed 33390325

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CRLX101 and Paclitaxel in people with Ovarian Cancer, run by NewLink Genetics Corporation at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02389985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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