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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

Sponsor
NewLink Genetics Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT02389985
Collaborator
(none)
30
Enrollment
7
Locations
1
Arm
39.6
Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
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 :
Jul 1, 2015
Actual Primary Completion Date :
Jun 4, 2018
Actual Study Completion Date :
Oct 18, 2018

Arms and Interventions

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 Names:
  • NLG207

    • Drug: Paclitaxel
    Other Names:
  • Taxol

    		•

    Outcome Measures

    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. [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 [6 months]

      PK

    Other Outcome Measures

    1. 2. To assess the overall safety and tolerability of CRLX101 in combination with weekly paclitaxel. [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. [6 months]

      PFS per RECIST 1.1 with scans every 2 cycles

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    1. Patients must have adequate bone marrow, renal, hepatic, and neurologic functions

    2. Patients should be free of active infection requiring parenteral antibiotics.

    3. 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.

    4. Any prior radiation therapy must be discontinued at least four weeks prior to registration.

    5. Major surgery within 28 days (four weeks) prior to registration.

    6. Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease.

    7. Patients must have a GOG performance status of 0 or 1.

    8. 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.

    1. 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.

    1. Patients with known active hepatitis or HIV.

    2. 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.

    3. Patients with clinically significant cardiovascular disease.

    4. Patients with serous non-healing wound, ulcer, or bone fracture.

    5. Patients with active bleeding or pathologic conditions that carry high risk of bleeding

    6. Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition.

    7. Patients with active infection requiring parenteral antibiotics.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 Washington University Saint Louis Missouri United States 63110
    3 The Ohio State University Columbus Ohio United States 43210
    4 University of Oklahoma / Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    5 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    6 Women & Infants Hospital of Rhode Island Providence Rhode Island United States 02095
    7 University of Virginia Health System Charlottesville Virginia United States 22901

    Sponsors and Collaborators

    • NewLink Genetics Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NewLink Genetics Corporation
    ClinicalTrials.gov Identifier:
    NCT02389985
    Other Study ID Numbers:
    • CRLX101-209
    First Posted:
    Mar 17, 2015
    Last Update Posted:
    May 28, 2020
    Last Verified:
    May 1, 2020
    Additional relevant MeSH terms:
    Paclitaxel

    Study Results

    No Results Posted as of May 28, 2020