Brief Title
A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
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
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 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.
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 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Dose limiting toxicity(DLT)
Secondary Outcome
Maximal tolerable dose(MTD)
Condition
Ovarian Epithelial Cancer
Intervention
Gimatecan 0.6mg/m2/d
Study Arms / Comparison Groups
Gimatecan 0.6mg/m2/d
Description: Three or six patients will be treated with the dose of 0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
July 11, 2019
Completion Date
December 2022
Primary Completion Date
December 2019
Eligibility Criteria
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 Ⅱ 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.
Gender
Female
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Hong Zheng, MD, 13641356816, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04029909
Organization ID
NTL-LEES-2018-01
Responsible Party
Sponsor
Study Sponsor
Lee's Pharmaceutical Limited
Study Sponsor
Hong Zheng, MD, Study Director, Beijing Tumor Hospital
Verification Date
July 2019