Ovarian Epithelial CancerPhase 1NCT04029909
A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
A Phase 1 study testing Gimatecan 0.6mg/m2/d, 0.8mg/m2/d and 0.4mg/m2/d in people with Ovarian Epithelial Cancer and Fallopian Tube Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Gimatecan 0.6mg/m2/d, 0.8mg/m2/d and 0.4mg/m2/d
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2019to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tumor Hospital
Beijing, Beijing Municipality
Hong Zheng, MD, 13641356816, Zhhong306@Hotmail.com
About this study
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
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.
Read the 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.
- Being tested
- Gimatecan 0.6mg/m2/d, 0.8mg/m2/d, 0.4mg/m2/d
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gimatecan 0.6mg/m2/dDrug
0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
0.8mg/m2/dDrug
0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
0.4mg/m2/dDrug
0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: 0.4mg/m2/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after first dose
Secondary outcomes (1)
Maximal tolerable dose(MTD)
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
Measured: 28 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start11 Jul 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zheng, MD, Study director, Beijing Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029909
- Sponsor's protocol ID
- NTL-LEES-2018-01
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04029909
- Acronym / sponsor ID
- NTL-LEES-2018-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gimatecan 0.6mg/m2/d | Experimental | Drug: Gimatecan 0.6mg/m2/dThree 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. |
| Gimatecan 0.8mg/m2/d | Experimental | Drug: 0.8mg/m2/dThree 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. |
| Gimatecan 0.4mg/m2/d | Experimental | Drug: 0.4mg/m2/dThree 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gimatecan 0.6mg/m2/d0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan | Drug | Gimatecan 0.6mg/m2/d |
| 0.8mg/m2/d0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan | Drug | Gimatecan 0.8mg/m2/d |
| 0.4mg/m2/d0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan | Drug | Gimatecan 0.4mg/m2/d |
Primary outcome
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.
1 secondary outcome
Maximal tolerable dose(MTD)
Time frame: 28 days after first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Zheng, MD study director
Beijing Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gimatecan 0.6mg/m2/d, 0.8mg/m2/d and 0.4mg/m2/d in people with Ovarian Epithelial Cancer and Fallopian Tube Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Zheng, MD (13641356816, Zhhong306@Hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity(DLT) (time frame: 28 days after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.