A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

Fallopian Tube Cancer Clinical Trial

Official title:

A Phase I Clinical Study of Gimatecan (ST 1481) in Patients With Platinum-resistant or Sensitive Relapsing/Refractory Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029909
• Other study ID #: NTL-LEES-2018-01
• Status: Recruiting
• Phase: Phase 1
• Start date: July 11, 2019
• Est. completion date: December 2022

Study information

• Verified date: July 2019
• Source: Lee's Pharmaceutical Limited
• Contact: Hong Zheng, MD
• Phone: 13641356816
• Email: Zhhong306[@]Hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, open-label, dose-escalation ,and multidose study, aiming to investigate the safety, tolerability and pharmacokinetics of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. To explore the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) of oral administration of Gimatecan capsules 5 consecutive days, every 28 days.

Description:

The clinical trial is used the traditional 3 +3 design and conducted in two dose groups, 0.6mg/m2/d and 0.8mg/m2/d, with an improved dose escalation design. The initial dose is 0.6mg/m2, once a day for 5 consecutive days, every 28 days for a course of treatment. Subjects are assigned to the corresponding dose group according to the order of enrolling. DLT is observed within 28 days of the first dose of Gimatecan. In the absence of DLT as prescribed by the protocol, the next dose group is started until the maximum tolerated dose (MTD) is observed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients must have stage III or IV ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer.

2. Definite histopathological diagnosis.

3. Failed with treatment for taxane/doxorubicin and platinum.

4. Must have measurable disease with at least 1 unidimensional measurable lesion base on RECIST1.1. When evaluating the efficacy of patients with CA125 level, CA125 abnormalities caused by other reasons should be excluded. According to the Gynecologic Cancer Intergroup-GCIG standard, the baseline serum CA125 level of patients within 2 weeks before treatment should be =2 upper limit of normal.

5. Age between 18-65(inclusive).

6. ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1.

7. To estimated life expectancy of at least 3 months.

8. Appropriate blood routine, liver and kidney function.

9. No allergic history of camptothecin.

10. Patients who are able to take strict contraceptive measures during the trial and within 4 months after the end of the trial.

11. The patients are able to swallow and maintain oral medication.

12. More than 4 weeks from the end of previous surgery, chemotherapy, radiotherapy (non-pelvic and peritoneal sites) and targeted therapy before the study and the body had recovered (the treatment-related toxicity grade is no more than grade 1, except for hair loss and pigmentation).

13. Patients voluntarily give written informed consent to participate in the study.

Exclusion Criteria:

1. The patients are treated with irinotecan or topotecan or with any topoisomerase I inhibitor regimen prior to enrollment.

2. Patients who use other experimental drugs or conducted other clinical trials at the same time within 30 days before participate in the study.

3. To received radiotherapy of pelvic cavity and abdomen.

4. Smoking more than 5 cigarettes per day in the past year.

5. Suspected or real alcohol dependence with an average alcohol intake of more than 2 units per day for 3 months.

6. Active infection.

7. patients with the history of gastrointestinal surgery or that may change drug absorption and activity in the body.

8. Serious cardiovascular disease, including ? magnitude abnormal cardiac function.

9. having a clear history of neuropathy or mental disorders (including epilepsy or dementia).

10. Human immunodeficiency virus(HIV) positive, untreated active hepatitis.

11. Suffering from other malignant tumors other than this diseases in 5 years, except for basal cell carcinoma of skin, skin squamous cell carcinoma, primary cervical carcinoma and breast cancer without recurrence and metastasis after radical operation.

12. Brain metastasis.

13. Female with pregnant or lactating.

14. Patients who are considered unsuitable to participate in the study.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Epithelial Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cancer

Intervention

Drug:
• Gimatecan 0.6mg/m2/d
0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
• 0.8mg/m2/d
0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
• 0.4mg/m2/d
0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan

Locations

Country	Name	City	State
China	Beijing Tumor Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The overall response rate(ORR)	The proportion of subjects who achieve the optimal objective response rate(PR or CR).	through study completion, an average of 2 years
Other	AUC(0-t)	Area under curve 0-t	28 days after first dose
Other	Cmax	Peak concentration	28 days after first dose
Other	Tmax	Peak concentration	28 days after first dose
Other	T1/2	Half life	28 days after first dose
Primary	Dose limiting toxicity(DLT)	Adverse events of level 3 or above related to the study drug occurring within 28 days after the first dose as assessed by CTCAE v5.0.	28 days after first dose
Secondary	Maximal tolerable dose(MTD)	DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.	28 days after first dose