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Trial record 1 of 14 for:    CRLX101
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A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT02389985
Recruitment Status : Terminated (Company decision)
First Posted : March 17, 2015
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation

Brief 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: CRLX101 Drug: Paclitaxel Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : October 18, 2018


Arm Intervention/treatment
Experimental: CRLX101 and weekly paclitaxel
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.
Drug: CRLX101
Other Name: NLG207

Drug: Paclitaxel
Other Name: Taxol




Primary Outcome Measures :
  1. 1. 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. [ Time Frame: 6 months ]
    The highest dose with <2 patients with DLTs out of 6 DLT-evaluable patients


Secondary Outcome Measures :
  1. Comparison of pharmacokinetic perimeters including max concentration (Cmax), time to maximum concentration (Tmax), AUC, elimination half-life for CRLX101 and paclitaxel [ Time Frame: 6 months ]
    PK


Other Outcome Measures:
  1. 2. To assess the overall safety and tolerability of CRLX101 in combination with weekly paclitaxel. [ Time Frame: 6 months ]
    AEs, changes in clinical status, vital signs, and laboratory data

  2. To assess the anti-tumor activity of CRLX101 when administered concomitantly with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian fallopian tube or primary peritoneal cancer. [ Time Frame: 6 months ]
    PFS per RECIST 1.1 with scans every 2 cycles



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389985


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma / Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02095
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22901
Sponsors and Collaborators
NewLink Genetics Corporation

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Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT02389985     History of Changes
Other Study ID Numbers: CRLX101-209
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Paclitaxel
Camptothecin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors