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

Primary Purpose

Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Gimatecan 0.6mg/m2/d
0.8mg/m2/d
0.4mg/m2/d
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Gimatecan 0.6mg/m2/d

Gimatecan 0.8mg/m2/d

Gimatecan 0.4mg/m2/d

Arm 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.

Three or six patients will be treated with the dose of 0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration.

Three or six patients will be treated with the dose of 0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximal tolerable dose(MTD)
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.

Full Information

First Posted
July 19, 2019
Last Updated
July 21, 2019
Sponsor
Lee's Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04029909
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gimatecan 0.6mg/m2/d
Arm Type
Experimental
Arm 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.
Arm Title
Gimatecan 0.8mg/m2/d
Arm Type
Experimental
Arm Description
Three or six patients will be treated with the dose of 0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration.
Arm Title
Gimatecan 0.4mg/m2/d
Arm Type
Experimental
Arm Description
Three or six patients will be treated with the dose of 0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration.
Intervention Type
Drug
Intervention Name(s)
Gimatecan 0.6mg/m2/d
Intervention Description
0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
Intervention Type
Drug
Intervention Name(s)
0.8mg/m2/d
Intervention Description
0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
Intervention Type
Drug
Intervention Name(s)
0.4mg/m2/d
Intervention Description
0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan
Primary Outcome Measure Information:
Title
Dose limiting toxicity(DLT)
Description
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.
Time Frame
28 days after first dose
Secondary Outcome Measure Information:
Title
Maximal tolerable dose(MTD)
Description
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
Time Frame
28 days after first dose
Other Pre-specified Outcome Measures:
Title
The overall response rate(ORR)
Description
The proportion of subjects who achieve the optimal objective response rate(PR or CR).
Time Frame
through study completion, an average of 2 years
Title
AUC(0-t)
Description
Area under curve 0-t
Time Frame
28 days after first dose
Title
Cmax
Description
Peak concentration
Time Frame
28 days after first dose
Title
Tmax
Description
Peak concentration
Time Frame
28 days after first dose
Title
T1/2
Description
Half life
Time Frame
28 days after first dose

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Zheng, MD
Phone
13641356816
Email
Zhhong306@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Zheng, MD
Organizational Affiliation
Beijing Tumor Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tumor Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zheng, MD
Phone
13641356816
Email
Zhhong306@Hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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