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A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer

Primary Purpose

Platinum-resistant Ovarian Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum-resistant Ovarian Cancer focused on measuring platinum-refractory, platinum-resistant, ovarian cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects fully understand and voluntarily participate in this study and sign informed consent;
  2. Age ≥18, female;
  3. Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma (excluding low grade serous carcinoma and mucous carcinoma);
  4. Fail to respond to or progressed on the standard platinum-based therapy ;
  5. At least one measurable lesion according to RECIST v1.1;
  6. ECOG performance status of 0 to 2;
  7. Life expectancy ≥ 12 weeks;
  8. AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation);
  9. Adequate organ function;
  10. Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment;
  11. Fully comply with the protocol.

Exclusion Criteria:

  1. History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
  2. Untreated or symptomatic central nervous system (CNS) metastases;
  3. Pericardial effusion with clinical symptoms
  4. History of allotransplantation;
  5. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
  6. Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
  7. Use of other anticancer treatment within 4 weeks prior to the first dose administration;
  8. Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
  9. Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
  10. Thrombosis or thromboembolism within 6 months prior to screening;
  11. History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
  12. Impaired cardiac function or serious cardiac disease;
  13. Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2.
  14. Pregnant or lactating female;
  15. Serious and/or uncontrolled systemic diseases;
  16. Not suitable for this study as decided by the investigator due to other reasons.

Sites / Locations

  • Chongqing University Cancer HospitalRecruiting
  • Fujian Cancer Hospital
  • Guangxi Medical University Cancer HospitalRecruiting
  • Guizhou Cancer HospitalRecruiting
  • Harbin Medical University HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mitoxantrone Hydrochloride Liposome Injection

Arm Description

Subjects with Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.

Outcomes

Primary Outcome Measures

adverse events (AEs)
The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).

Secondary Outcome Measures

overall response rate (ORR)
To investigate the preliminary antitumor efficacy
duration of response (DoR)
To investigate the preliminary antitumor efficacy
duration of complete response (DCR)
To investigate the preliminary antitumor efficacy
progression-free survival (PFS)
To investigate the preliminary antitumor efficacy
overall survival (OS)
To investigate the preliminary antitumor efficacy

Full Information

First Posted
December 14, 2020
Last Updated
May 31, 2021
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04718376
Brief Title
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer
Official Title
A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
January 11, 2022 (Anticipated)
Study Completion Date
January 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer.
Detailed Description
This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer. At least 30 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles). Delays in drug administration is allowed from the cycle 2, however, the delays should be no more than 3 weeks. Dose adjustments after the cycle 2 is permitted, and the minimum dose is 12mg/m2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum-resistant Ovarian Cancer
Keywords
platinum-refractory, platinum-resistant, ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mitoxantrone Hydrochloride Liposome Injection
Arm Type
Experimental
Arm Description
Subjects with Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
Intervention Description
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
Primary Outcome Measure Information:
Title
adverse events (AEs)
Description
The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).
Time Frame
from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months
Secondary Outcome Measure Information:
Title
overall response rate (ORR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
Title
duration of response (DoR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Title
duration of complete response (DCR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Title
progression-free survival (PFS)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Title
overall survival (OS)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects fully understand and voluntarily participate in this study and sign informed consent; Age ≥18, female; Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma (excluding low grade serous carcinoma and mucous carcinoma); Fail to respond to or progressed on the standard platinum-based therapy ; At least one measurable lesion according to RECIST v1.1; ECOG performance status of 0 to 2; Life expectancy ≥ 12 weeks; AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation); Adequate organ function; Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment; Fully comply with the protocol. Exclusion Criteria: History of allergy to mitoxantrone hydrochloride or any excipients of the study drug; Untreated or symptomatic central nervous system (CNS) metastases; Pericardial effusion with clinical symptoms History of allotransplantation; Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection; Serious infection or interstitial pneumonia within 1 week prior to the first dose administration; Use of other anticancer treatment within 4 weeks prior to the first dose administration; Enrolled in any other clinical trials within 4 weeks prior to the first dose administration; Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period; Thrombosis or thromboembolism within 6 months prior to screening; History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ; Impaired cardiac function or serious cardiac disease; Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2. Pregnant or lactating female; Serious and/or uncontrolled systemic diseases; Not suitable for this study as decided by the investigator due to other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefang Xia
Phone
010-63932012
Email
xiaxuefang@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Zhou, Master
Organizational Affiliation
Chongqing University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Zhou, Master
Phone
18908384529
First Name & Middle Initial & Last Name & Degree
Qi Zhou, Master
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Xie, Bachelor
Phone
13705932393
First Name & Middle Initial & Last Name & Degree
Rong Xie, Bachelor
Facility Name
Guangxi Medical University Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhijun Yang, MD
Phone
18977194276
First Name & Middle Initial & Last Name & Degree
Zhijun Yang, MD
Facility Name
Guizhou Cancer Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Ouyang, MD
Phone
18275356814
First Name & Middle Initial & Last Name & Degree
Weiwei Ouyang, MD
Facility Name
Harbin Medical University Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ge Lou, MD
Phone
13303604488
First Name & Middle Initial & Last Name & Degree
Ge Lou, MD
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanlin Luo, Master
Phone
15038373216
First Name & Middle Initial & Last Name & Degree
Yanlin Luo, Master
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiling Li, MD
Phone
13307187507
First Name & Middle Initial & Last Name & Degree
Guiling Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer

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