- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04222842
CM082 in Patients With Myopic Choroidal Neovascularization (CNV)
March 7, 2021 updated by: AnewPharma
Phase I Study of CM082 in Patients With Myopic Choroidal Neovascularization (CNV)
This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With mCNV.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, open-label, single-arm, phase I Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with mCNV.
The study will be performed in two different parts, dose-escalation phase (Part 1) and dose-expansion phase (Part 2).
Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles.
There are three dose levels, 25mg BID,50mg QD and 50mg BID.
The total treatment period is tentatively set at 3 cycles (12 weeks).
Based on data from dose escalation studies, identify safe and effective doses for expanded enrollment studies.The assessment of the safety and efficacy will be done in 2、4、8、12weeks after the first dose.Also, single/multiple dose pharmacokinetics in these patients will be studied.
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Peking Union Medical College Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of active CNV secondary to pathologic myopia and the study eye must have the following lesion characteristics: (a)presence of high myopia with greater than -6 diopters of spherical equivalencef or anteroposterior elongation greater than 26 mm, (b) presence of at least 1 of the following lesion types: subfoveal; juxtafoveal; extrafoveal with involvement of the central macular area and margin of the optic disk with involvement of the central macular area, (c) vision loss due to the above causes, (d) ETDRS BCVA 24 to 78 letters.
- Patients with no previous anti-VEGF therapy.
- Adequate bone marrow, hepatic, and renal functions.
- Willing to sign the ICF and comply with the study protocol.
Exclusion Criteria:
- CNV due to causes other than mCNV.
- Any significant disease in the study eye that could compromise BCVA.
- Active eye infection in any eye.
Previous treatment with photodynamic therapy (PDT), external beam radiation, laser photocoagulation, or transpupillary thermotherapy within
1 month of the first dose.
- Intraocular surgery in the test eye within 3 months prior to the first dose.
- Any eye received intravitreal injection of corticosteroids within 3 months prior to first dose.
- Clinically significant, uncontrolled cardiovascular and cerebrovascular disease.
- Patients who had previously used strong inhibitors of CYP3A or strong inducers were discontinued from the first dose of CM082 <5 drug half-lives (except for withdrawals longer than 14 days).
- Active hepatitis B (serum HBV DNA ≥ 500 IU / ml), hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive.
- Swallowing dysfunction, active gastrointestinal disease, or other diseases that affect the absorption, distribution, metabolism, and excretion of drugs.
- Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of the first dose.
- Allergy to the ingredients of the study drug.
- Patients who have fertility needs and who cannot use effective methods of contraception during the study period and at least 3 months after the end of treatment (except for male patients after birth control or female patients after birth control or postmenopausal).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CM082 Tablet
Code Name: CM082 Tablet Other Name: X-82 Dosage and Administration: 25mg BID/50mg QD/50mg BID, P.O., two-week on/two-week off in four-week cycles until disease progression or unacceptable toxicity
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Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles.The total treatment period is tentatively set at 3 cycles (12 weeks).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-Limiting Toxicity(DLT)
Time Frame: the first cycle(the first four weeks)
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Any serious adverse event in eye or any ≥3 grade adverse reactions cannot be reduced to below grade 3 after treatment for more than 7 days.
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the first cycle(the first four weeks)
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Adverse event
Time Frame: 12 weeks
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Incidence of the adverse event after treatment
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Best-Corrected Visual Acuity (BCVA)
Time Frame: 12 weeks
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Change from baseline in mean BCVA (ETDRS)
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12 weeks
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Change in Choroidal Neovascularization (CNV) size
Time Frame: 12 weeks
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Change from baseline in mean CNV size (FA)
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12 weeks
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Change in Central Retinal Thickness
Time Frame: 12 weeks
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Change from baseline in mean central retinal thickness (OCT)
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2019
Primary Completion (Anticipated)
December 30, 2021
Study Completion (Anticipated)
December 30, 2021
Study Registration Dates
First Submitted
January 7, 2020
First Submitted That Met QC Criteria
January 7, 2020
First Posted (Actual)
January 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 10, 2021
Last Update Submitted That Met QC Criteria
March 7, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM082-OPH-I-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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