Epithelial Ovarian CancerPhase 2NCT04846842
A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
A Phase 2 study testing Gimatecan in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Lee's Pharmaceutical Limited.
Trial summary
This phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer. The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Gimatecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Jul 2023
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects were able to understand the informed consent, voluntarily participate in and sign the informed consent, with good compliance and cooperation with follow-up.
- A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer.
- Previous systematic treatment ≤ 2 lines, and progression in platinum based regimens or recurrence within 6 months after the end of platinum regimen. 1) Imaging progression of recurrence and progression should be clearly recorded;2) Neoadjuvant + adjuvant chemotherapy with platinum regimen ≥ 6 cycles, and platinum regimen after recurrence / progression ≥ 4 cycles;3) If there is progression during the treatment of platinum based regimen, the treatment cycle is not limited;4) Recurrence / progression within 6 months after the end of neoadjuvant / adjuvant therapy is considered to have received the first-line systematic treatment.
- Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- ≥18 years old;
- Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
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- Estimated life expectancy >3 months;
- The function of important organs meets the following requirements:
- white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
- ALT, AST≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN;
- serum albumin ≥ 28g/L;
- total bilirubin ≤ 1.5×ULN;
- serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;
- PT≤ 1.5×ULN;
- The subjects had no history of allergy to camptothecin or its components;
- Non surgical sterilization or female subjects of childbearing age need to use a medically approved contraceptive method after signing the informed consent, during the study treatment period and within 6 months after the end of the study treatment period; non surgical sterilization female subjects of childbearing age must have negative blood HCG test within 3 days before entering the study; and they must be in non lactation period.
- Taking drugs orally;
- The subjects had recovered and treatment will start more than 4 weeks after the end of previous surgery, chemotherapy, targeted therapy and radiotherapy.
Who cannot join
- Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
- Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan;
- Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment;
- Subjects with a history of major gastrointestinal surgery (e.g., total gastrectomy, small bowel resection) or gastrointestinal dysfunction that may alter drug absorption and activity in vivo;
- Severe cardiovascular disease, such as NYHA grade 3-4 heart failure;
- Patients who have been treated previously with intravenous or oral drugs that affect CYP isoenzymes within 7 days prior to the first dose of the investigational drug gimatecan;
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- A history of immunodeficiency (including a positive HIV test result);Presence of active hepatitis B , hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
- Pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment;
- Subjects with hereditary or acquired bleeding tendency (hemophilia, thrombocytopenia, etc.), interstitial pneumonia or pulmonary fibrosis, and active tuberculosis (whether or not treated) in the past year;
- Vaccinated with live attenuated vaccine within 4 weeks;
- Subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan;
- Subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis.
- Other considered unsuitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Study of Gimatecan in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
This phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer.
The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.
Read the detailed description
The study had 3 phases: screening phase, treatment phase and follow-up phase. During the treatment phase, the drug will continue to be administered until the progression of disease, complete remission , unacceptable toxicity.
- Being tested
- Gimatecan
- Keywords
- epithelial ovarian, fallopian tube or peritoneal cancer, Platinum resistant, chemotherapy, gimatecan
- 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.
GimatecanDrug
Also called ST1481
Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gimatecan group | Experimental | In Phase II study, patients will receive gimatecan at fixed dose level (0.8mg/m2/d, oral, every 4 weeks) until progressive disease (PD)、complete remission（CR）). Receives: Drug: Gimatecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Percentage of patients with objective response assessed by best overall response (BOR) and independent review committee （IRC） of either complete response(CR) or partial remission(PR) will be reported.
Measured: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Secondary outcomes (4)
Progression free survival (PFS)
The 2-year progression free survival of the whole group.
Measured: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Disease control rate (DCR)
will be reported.
Measured: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Duration of Response (DoR)
The 2-year overall survival of the whole group.
Measured: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
Overall survival (OS)
The 2-year overall survival of the whole group.
Measured: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ZHOU QI, Study director, Chongqing Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846842
- Sponsor's protocol ID
- ST1481-LEES-2020-13
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hurwitz JL, McCoy F, Scullin P, Fennell DA. New advances in the second-line treatment of small cell lung cancer. Oncologist. 2009 Oct;14(10):986-94. doi: 10.1634/theoncologist.2009-0026. Epub 2009 Oct 9.
PubMed 19819917
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gimatecan in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT04846842
- Acronym / sponsor ID
- ST1481-LEES-2020-13
- Keywords
- epithelial ovarian, fallopian tube or peritoneal cancer, Platinum resistant, chemotherapy, gimatecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 15 Apr 2021 (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 phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer.
The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.
Detailed description
The study had 3 phases: screening phase, treatment phase and follow-up phase. During the treatment phase, the drug will continue to be administered until the progression of disease, complete remission , unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gimatecan group | Experimental | Drug: GimatecanIn Phase II study, patients will receive gimatecan at fixed dose level (0.8mg/m2/d, oral, every 4 weeks) until progressive disease (PD)、complete remission（CR）). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The subjects were able to understand the informed consent, voluntarily participate in and sign the informed consent, with good compliance and cooperation with follow-up.
- A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer.
- Previous systematic treatment ≤ 2 lines, and progression in platinum based regimens or recurrence within 6 months after the end of platinum regimen. 1) Imaging progression of recurrence and progression should be clearly recorded;2) Neoadjuvant + adjuvant chemotherapy with platinum regimen ≥ 6 cycles, and platinum regimen after recurrence / progression ≥ 4 cycles;3) If there is progression during the treatment of platinum based regimen, the treatment cycle is not limited;4) Recurrence / progression within 6 months after the end of neoadjuvant / adjuvant therapy is considered to have received the first-line systematic treatment.
- Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- ≥18 years old;
Key exclusion criteria (13 listed)
- Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
- Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan;
- Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment;
- Subjects with a history of major gastrointestinal surgery (e.g., total gastrectomy, small bowel resection) or gastrointestinal dysfunction that may alter drug absorption and activity in vivo;
- Severe cardiovascular disease, such as NYHA grade 3-4 heart failure;
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 |
|---|---|---|
| GimatecanAlso: ST1481Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks. | Drug | Gimatecan group |
Primary outcome
Objective response rate (ORR)
Time frame: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Percentage of patients with objective response assessed by best overall response (BOR) and independent review committee （IRC） of either complete response(CR) or partial remission(PR) will be reported.
4 secondary outcomes
Progression free survival (PFS)
Time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Disease control rate (DCR)
Time frame: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Duration of Response (DoR)
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Results publication: PubMed 19819917Hurwitz JL, McCoy F, Scullin P, Fennell DA. New advances in the second-line treatment of small cell lung cancer. Oncologist. 2009 Oct;14(10):986-94. doi: 10.1634/theoncologist.2009-0026. Epub 2009 Oct 9.
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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.
ZHOU QI study director
Chongqing Tumor Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gimatecan in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Lee's Pharmaceutical Limited.
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 18 inclusion and 13 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ZHOU QI (13708384529, qizhou9128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846842, which also lists 1 linked publication.
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 19 Apr 2021.