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出境医 / 临床实验 / A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

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

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.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Drug: Gimatecan 0.6mg/m2/d Drug: 0.8mg/m2/d Drug: 0.4mg/m2/d Phase 1

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Gimatecan 0.6mg/m2/d
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.
 Drug: Gimatecan 0.6mg/m2/d
0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
Experimental: Gimatecan 0.8mg/m2/d
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.
 Drug: 0.8mg/m2/d
0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
Experimental: Gimatecan 0.4mg/m2/d
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.
 Drug: 0.4mg/m2/d
0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan
Outcome Measures
Primary Outcome Measures :
  1. Dose limiting toxicity(DLT) [ Time Frame: 28 days after first dose ]
    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 :
  1. Maximal tolerable dose(MTD) [ Time Frame: 28 days after first dose ]
    DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.


Other Outcome Measures:
  1. The overall response rate(ORR) [ Time Frame: through study completion, an average of 2 years ]
    The proportion of subjects who achieve the optimal objective response rate(PR or CR).

  2. AUC(0-t) [ Time Frame: 28 days after first dose ]
    Area under curve 0-t

  3. Cmax [ Time Frame: 28 days after first dose ]
    Peak concentration

  4. Tmax [ Time Frame: 28 days after first dose ]
    Peak concentration

  5. T1/2 [ Time Frame: 28 days after first dose ]
    Half life


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hong Zheng, MD 13641356816 Zhhong306@Hotmail.com

Locations
Layout table for location information
China, Beijing
Beijing Tumor Hospital Recruiting
Beijing, Beijing, China
Contact: Hong Zheng, MD    13641356816    Zhhong306@Hotmail.com   
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
Layout table for investigator information
Study Director: Hong Zheng, MD Beijing Tumor Hospital
Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE July 11, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2019) 		Dose limiting toxicity(DLT) [ Time Frame: 28 days after first dose ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2019) 		Maximal tolerable dose(MTD) [ Time Frame: 28 days after first dose ]
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 21, 2019)
  • The overall response rate(ORR) [ Time Frame: through study completion, an average of 2 years ]
    The proportion of subjects who achieve the optimal objective response rate(PR or CR).
  • AUC(0-t) [ Time Frame: 28 days after first dose ]
    Area under curve 0-t
  • Cmax [ Time Frame: 28 days after first dose ]
    Peak concentration
  • Tmax [ Time Frame: 28 days after first dose ]
    Peak concentration
  • T1/2 [ Time Frame: 28 days after first dose ]
    Half life
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Epithelial Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
Intervention  ICMJE
  • Drug: Gimatecan 0.6mg/m2/d
    0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
  • Drug: 0.8mg/m2/d
    0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
  • Drug: 0.4mg/m2/d
    0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan
Study Arms  ICMJE
  • Experimental: Gimatecan 0.6mg/m2/d
    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.
    Intervention: Drug: Gimatecan 0.6mg/m2/d
  • Experimental: Gimatecan 0.8mg/m2/d
    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.
    Intervention: Drug: 0.8mg/m2/d
  • Experimental: Gimatecan 0.4mg/m2/d
    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: Drug: 0.4mg/m2/d
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2019) 		12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hong Zheng, MD 13641356816 Zhhong306@Hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029909
Other Study ID Numbers  ICMJE NTL-LEES-2018-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lee's Pharmaceutical Limited
Study Sponsor  ICMJE Lee's Pharmaceutical Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hong Zheng, MD Beijing Tumor Hospital
PRS Account Lee's Pharmaceutical Limited
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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