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A Study of Navicixizumab in Patients With Platinum Resistant Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT05043402
Recruitment Status : Not yet recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
OncXerna Theraputics, Inc.

Brief Summary:
This is a Phase 3, randomized, open-label, 2-stage, multicenter study of navicixizumab with or without paclitaxel compared with paclitaxel monotherapy in patients with platinum-resistant advanced epithelial ovarian cancer and specific biomarkers, as measured by the proprietary and validated Xerna™ TME Panel biomarker assay. Eligible patients must have received at least 2 prior regimens but not more than 5 prior regimens, including treatment with a monoclonal antibody angiogenesis inhibitor (e.g., bevacizumab), must be considered platinum-resistant, and must be considered appropriate to receive single-agent paclitaxel chemotherapy as a next line of therapy. All patients must be willing and able to provide a formalin-fixed paraffin embedded (FFPE) archive or core tumor sample collected during screening for classification as B+ or B- biomarker status based on RNA expression data from the Xerna™ TME Panel biomarker assay. The co-primary efficacy endpoints are ORR by RECIST v1.1 and PFS (as assessed by blinded independent radiological review [BIRR]) analyzed at different timepoints. Analysis of the ORR primary efficacy endpoints will occur at the end of Stage 1 and at the end of Stage 2; the PFS primary efficacy endpoint will be analyzed at the end of Stage 2.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Drug: navicixizumab Device: Xerna™ TME Panel Phase 3

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Study Type : Interventional
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Study of Navicixizumab Plus Paclitaxel and Navicixizumab Monotherapy in Comparison to Paclitaxel Monotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 15, 2023
Estimated Study Completion Date : August 15, 2024


Arm Intervention/treatment
Experimental: Combination navicixizumab + paclitaxel
Combination navicixizumab + paclitaxel: navicixizumab 3 mg/kg Q2W of a 28 day cycle (i.e., Days 1 and 15); paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28 day cycle
Drug: navicixizumab
navicixizumab IV
Other Name: navi

Device: Xerna™ TME Panel
RNA-seq-based biomarker platform that classifies any given patient tumor sample into phenotypes based on the dominant biology of the tumor microenvironment (TME).

Active Comparator: Paclitaxel monotherapy
Paclitaxel monotherapy: paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
Device: Xerna™ TME Panel
RNA-seq-based biomarker platform that classifies any given patient tumor sample into phenotypes based on the dominant biology of the tumor microenvironment (TME).

Experimental: Navicixizumab monotherapy
Navicixizumab monotherapy: navicixizumab 3 mg/kg Q2W of a 28-day cycle (i.e., Days 1 and 15)
Drug: navicixizumab
navicixizumab IV
Other Name: navi

Device: Xerna™ TME Panel
RNA-seq-based biomarker platform that classifies any given patient tumor sample into phenotypes based on the dominant biology of the tumor microenvironment (TME).




Primary Outcome Measures :
  1. ORR [ Time Frame: Up to 2 years ]
    Overall Response Rate defined as the proportion of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR), by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

  2. PFS [ Time Frame: Up to 2 years ]
    Progression Free Survival


Secondary Outcome Measures :
  1. OS [ Time Frame: Up to 2 years ]
    Overall Survival

  2. TTR [ Time Frame: Up to 2 years ]
    Time to response

  3. DCR [ Time Frame: Up to 2 years ]
    Disease control rate , defined as the proportion of patients with stable disease (SD) or a confirmed BOR of CR or PR

  4. DOR [ Time Frame: Up to 2 years ]
    Duration of Response



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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:

Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer Patients must have received ≥2 and not more than 5 prior therapies, including at least 1 line of therapy containing bevacizumab (or biosimilar).

Patients must be considered platinum-resistant, defined as progression within 6 months from completion of a platinum-containing therapy Patient must be considered appropriate for treatment with weekly paclitaxel monotherapy as the next line of therapy.

Patient must be willing and able to provide an FFPE archival or core tumor sample for determination of biomarker status on the Xerna™ TME Panel biomarker assay (positive or negative) prior to study treatment.

Presence of at least one measurable lesion, as defined by RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Adequate organ function

Exclusion Criteria:

Non-epithelial ovarian carcinoma. Ovarian tumors with low malignant potential (i.e., borderline tumors). Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen).

Patient has received an anti-angiogenic product other than bevacizumab or biosimilar.

Patient has any of the following conditions related to cardiac function:

  • congestive heart failure
  • history of myocardial infarction, cerebral vascular accident, or transient ischemic attacks within 6 months
  • History of cardiac ischemia or heart failure within 6 months
  • Baseline B-type natriuretic peptide (BNP) value >100 pg/mL or N-terminal-proBNP (NT-proBNP) value of > 125 pg/mL.
  • LVEF <50%.
  • Peak tricuspid velocity >3.0 m/s on Doppler ECHO.
  • Clinically significant ECG abnormality, as assessed by the investigator Blood pressure (BP) >140/90 mmHg History of bowel obstruction, including sub-occlusive disease, related to the underlying disease Hemoptysis >2.5 mL within 8 weeks prior Major surgical procedure, or significant traumatic injury within 28 days Uncontrolled seizure disorder or active neurologic disease Patients with a cardiac aneurysm.

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): NCT05043402


Contacts
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Contact: OncXerna Therapeutics 781-907-7810 medical@oncxerna.com

Sponsors and Collaborators
OncXerna Theraputics, Inc.
Investigators
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Principal Investigator: Kathleen N Moore, MD,MS University of Oklahoma
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Responsible Party: OncXerna Theraputics, Inc.
ClinicalTrials.gov Identifier: NCT05043402    
Other Study ID Numbers: ONCX-NAV-G301
2021-001933-38 ( EudraCT Number )
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by OncXerna Theraputics, Inc.:
Platinum-Resistant
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases