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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04718376
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Platinum-resistant Ovarian Cancer Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : January 11, 2022
Estimated Study Completion Date : January 11, 2024


Arm Intervention/treatment
Experimental: Mitoxantrone Hydrochloride Liposome Injection
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.
Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).




Primary Outcome Measures :
  1. adverse events (AEs) [ Time Frame: from the initiation of the first dose to 28 days after the last dose,assessed up to 36 months ]
    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 :
  1. overall response rate (ORR) [ Time Frame: From the enrollment to the final documentation of response of the last subject (assessed up to 36 months) ]
    To investigate the preliminary antitumor efficacy

  2. duration of response (DoR) [ Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months ]
    To investigate the preliminary antitumor efficacy

  3. duration of complete response (DCR) [ Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months ]
    To investigate the preliminary antitumor efficacy

  4. progression-free survival (PFS) [ Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months ]
    To investigate the preliminary antitumor efficacy

  5. overall survival (OS) [ Time Frame: From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months) ]
    To investigate the preliminary antitumor efficacy



Information from the National Library of Medicine

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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. 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.

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): NCT04718376


Contacts
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Contact: Xuefang Xia 010-63932012 xiaxuefang@mail.ecspc.com

Locations
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China, Chongqing
Chongqing University Cancer Hospital Recruiting
Chongqing, Chongqing, China, 400030
Contact: Qi Zhou, Master    18908384529      
Principal Investigator: Qi Zhou, Master         
China, Fujian
Fujian Cancer Hospital Not yet recruiting
Fuzhou, Fujian, China, 350014
Contact: Rong Xie, Bachelor    13705932393      
Principal Investigator: Rong Xie, Bachelor         
China, Guangxi
Guangxi Medical University Cancer Hospital Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Zhijun Yang, MD    18977194276      
Principal Investigator: Zhijun Yang, MD         
China, Guizhou
Guizhou Cancer Hospital Recruiting
Guiyang, Guizhou, China, 550000
Contact: Weiwei Ouyang, MD    18275356814      
Principal Investigator: Weiwei Ouyang, MD         
China, Heilongjiang
Harbin Medical University Hospital Not yet recruiting
Harbin, Heilongjiang, China, 150081
Contact: Ge Lou, MD    13303604488      
Principal Investigator: Ge Lou, MD         
China, Henan
Henan Cancer Hospital Not yet recruiting
Zhengzhou, Henan, China, 450000
Contact: Yanlin Luo, Master    15038373216      
Principal Investigator: Yanlin Luo, Master         
China, Hubei
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430022
Contact: Guiling Li, MD    13307187507      
Principal Investigator: Guiling Li, MD         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Qi Zhou, Master Chongqing University Cancer Hospital
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04718376    
Other Study ID Numbers: HE071-CSP-015
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
platinum-refractory, platinum-resistant, ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
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
Mitoxantrone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action