CM082 in Patients With Myopic Choroidal Neovascularization (CNV)

NCT ID: NCT04222842

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2021-12-30

Brief Summary

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.

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.

Conditions

Myopic Choroidal Neovascularisation

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CM082

Intervention Type: DRUG

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).

Interventions

CM082

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).

Intervention Type: DRUG

Other Intervention Names

X-82

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AnewPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youxin Chen

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

CM082-OPH-I-102

Identifier Type: -

Identifier Source: org_study_id