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

NCT04718376 | Terminated Phase 1

• 1 other identifier: HE071-CSP-015
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

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.

Conditions

Platinum-resistant Ovarian Cancer

Keywords

platinum-refractory, platinum-resistant, ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months

Secondary Outcomes (5)

• overall response rate (ORR)

  From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)

• duration of response (DoR)

  From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

• duration of complete response (DCR)

  From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

• progression-free survival (PFS)

  From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

• overall survival (OS)

  From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

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)

Interventions

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) DRUG

All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (7)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

Location

Guizhou Cancer Hospital

Guiyang, Guizhou, 550000, China

Location

Harbin Medical University Hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Injections, Intravenous

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Qi Zhou, Master

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 22, 2021
• Study Start: January 12, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: March 7, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)