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Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Primary Purpose

Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
M-Trap
Sponsored by
MTrap, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer Stage IIIC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Is a female ≥18 years old.
  2. Presents with a diagnosis of Stage IIIC ovarian cancer.
  3. Presents with high-grade serous carcinoma.

  4. Has one of the following:

    1. Visible residual tumor ≤1 cm after primary tumor debulking surgery.
    2. Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery.
    3. Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery.
  5. ECOG performance status of 0 or 1.
  6. Is willing to comply with required follow-up study visits.
  7. Is willing and able to provide written informed consent.

Exclusion Criteria:

  1. Has a life expectancy of <3 months.
  2. Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating.
  3. Will be receiving intraperitoneal chemotherapy.
  4. Has undergone prior treatment with abdominal and/or pelvic radiotherapy.
  5. Has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  6. Presence of central nervous system or cerebral metastases.
  7. Recurrent ovarian cancer.
  8. Complete resection with no residual tumor after primary tumor debulking surgery.
  9. Suboptimal resection with >1 cm residual tumor after primary or interval tumor debulking surgery.
  10. Is simultaneously enrolled in another investigational study.
  11. Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer.
  12. Has a known hypersensitivity to carboplatin or paclitaxel.
  13. Is concurrently using other antineoplastic agents.

Sites / Locations

  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Castellon University General Hospital
  • MD Anderson Cancer Center
  • Hospital La Paz Madrid
  • Complexo Hospitalario Universitario de Santiago
  • Valencia-Hospital General
  • Hospital Universitrio y Politècnico La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

M-Trap

Arm Description

Outcomes

Primary Outcome Measures

Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites.
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures
Performance: Number of Participants With Histological Evidence of Tumor Cell Capture
Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal

Secondary Outcome Measures

Safety: Number of Participants With Device-related Long-term Adverse Event Reporting
Device-related long-term adverse events and serious adverse events reported through 18 months
Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting
Procedure-related long-term adverse events and serious adverse events reported through 18 months
Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status
Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization.

Full Information

First Posted
March 15, 2017
Last Updated
January 14, 2020
Sponsor
MTrap, Inc.
Collaborators
MedPass International
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1. Study Identification

Unique Protocol Identification Number
NCT03085238
Brief Title
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
Official Title
Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MTrap, Inc.
Collaborators
MedPass International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-center, non-blinded, single-arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M-Trap
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
M-Trap
Intervention Description
Device(s) will be surgically implanted in the peritoneal cavity. Up to three (3) M-Trap devices will be surgically implanted via laparotomy in the right and left paracolic (pelvic) gutters and behind segment 6 of the liver within the peritoneal cavity of the patient at the time of surgical resection. Patients will receive standard platinum-based chemotherapy. If the cancer is diagnosed to have recurred, M-Trap devices with captured tumor cells will be removed via minimally invasive surgery (laparoscopy).
Primary Outcome Measure Information:
Title
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
Description
The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites.
Time Frame
6 months
Title
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
Description
An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures
Time Frame
30 days
Title
Performance: Number of Participants With Histological Evidence of Tumor Cell Capture
Description
Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal
Time Frame
Time of device removal, an average of 13.3 months
Secondary Outcome Measure Information:
Title
Safety: Number of Participants With Device-related Long-term Adverse Event Reporting
Description
Device-related long-term adverse events and serious adverse events reported through 18 months
Time Frame
18 months
Title
Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting
Description
Procedure-related long-term adverse events and serious adverse events reported through 18 months
Time Frame
18 months
Title
Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status
Description
Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization.
Time Frame
Time of recurrence, an average of 14.5 months
Other Pre-specified Outcome Measures:
Title
Number of Devices Implanted
Description
Number of devices implanted at conclusion of debulking surgery.
Time Frame
Immediately post-procedure
Title
Disease Focalization Score by Recurrence Status
Description
Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device
Time Frame
Time of recurrence, an average of 14.5 months
Title
Number of Participants With Reasons for Device Removal
Description
Reason that device removal was planned, regardless of whether or not it was completed.
Time Frame
Time of device removal, an average of 13.3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is a female ≥18 years old. Presents with a diagnosis of Stage IIIC ovarian cancer. Presents with high-grade serous carcinoma. Has one of the following: Visible residual tumor ≤1 cm after primary tumor debulking surgery. Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery. Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery. ECOG performance status of 0 or 1. Is willing to comply with required follow-up study visits. Is willing and able to provide written informed consent. Exclusion Criteria: Has a life expectancy of <3 months. Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating. Will be receiving intraperitoneal chemotherapy. Has undergone prior treatment with abdominal and/or pelvic radiotherapy. Has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Presence of central nervous system or cerebral metastases. Recurrent ovarian cancer. Complete resection with no residual tumor after primary tumor debulking surgery. Suboptimal resection with >1 cm residual tumor after primary or interval tumor debulking surgery. Is simultaneously enrolled in another investigational study. Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer. Has a known hypersensitivity to carboplatin or paclitaxel. Is concurrently using other antineoplastic agents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Gil-Moreno, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Castellon University General Hospital
City
Castelló
ZIP/Postal Code
12004
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital La Paz Madrid
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Valencia-Hospital General
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitrio y Politècnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

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