Status:
UNKNOWN
A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Ovarian Epithelial Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief 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 T...
Detailed 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 fo...
Eligibility Criteria
Inclusion
- Patients must have stage III or IV ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer.
- Definite histopathological diagnosis.
- Failed with treatment for taxane/doxorubicin and platinum.
- 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.
- Age between 18-65(inclusive).
- ECOG（Eastern Cooperative Oncology Group） performance status of 0 or 1.
- To estimated life expectancy of at least 3 months.
- Appropriate blood routine, liver and kidney function.
- No allergic history of camptothecin.
- Patients who are able to take strict contraceptive measures during the trial and within 4 months after the end of the trial.
- The patients are able to swallow and maintain oral medication.
- 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).
- Patients voluntarily give written informed consent to participate in the study.
Exclusion
- The patients are treated with irinotecan or topotecan or with any topoisomerase I inhibitor regimen prior to enrollment.
- Patients who use other experimental drugs or conducted other clinical trials at the same time within 30 days before participate in the study.
- To received radiotherapy of pelvic cavity and abdomen.
- Smoking more than 5 cigarettes per day in the past year.
- Suspected or real alcohol dependence with an average alcohol intake of more than 2 units per day for 3 months.
- Active infection.
- patients with the history of gastrointestinal surgery or that may change drug absorption and activity in the body.
- Serious cardiovascular disease, including Ⅱ magnitude abnormal cardiac function.
- having a clear history of neuropathy or mental disorders (including epilepsy or dementia).
- Human immunodeficiency virus(HIV) positive, untreated active hepatitis.
- 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.
- Brain metastasis.
- Female with pregnant or lactating.
- Patients who are considered unsuitable to participate in the study.
Key Trial Info
Start Date :
July 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04029909
Start Date
July 11 2019
End Date
December 1 2022
Last Update
July 23 2019
Active Locations (1)
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1
Beijing Tumor Hospital
Beijing, Beijing Municipality, China