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

NCT04029909 | Unknown Phase 1

• 1 other identifier: NTL-LEES-2018-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maximal tolerable dose(MTD)

  28 days after first dose

Other Outcomes (5)

• The overall response rate(ORR)

  through study completion, an average of 2 years

• AUC(0-t)

  28 days after first dose

• Cmax

  28 days after first dose

Study Arms (3)

Gimatecan 0.6mg/m2/d

EXPERIMENTAL

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

Gimatecan 0.8mg/m2/d

EXPERIMENTAL

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

Gimatecan 0.4mg/m2/d

EXPERIMENTAL

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

Interventions

Gimatecan 0.6mg/m2/d DRUG

0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan

Gimatecan 0.6mg/m2/d

0.8mg/m2/d DRUG

0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan

Gimatecan 0.8mg/m2/d

0.4mg/m2/d DRUG

0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan

Gimatecan 0.4mg/m2/d

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Beijing Tumor Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

ST 1481

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Hong Zheng, MD

  Beijing Tumor Hospital

  STUDY DIRECTOR

Central Study Contacts

Hong Zheng, MD

CONTACT

13641356816; Zhhong306@Hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: July 11, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)