CM082 in Patients With Myopic Choroidal Neovascularization (CNV)

NCT04222842 | Suspended Phase 1

• 1 other identifier: CM082-OPH-I-102
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopic Choroidal Neovascularisation

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity(DLT)

  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.

  the first cycle(the first four weeks)

• Adverse event

  Incidence of the adverse event after treatment

  12 weeks

Secondary Outcomes (3)

• Change in Best-Corrected Visual Acuity (BCVA)

  12 weeks

• Change in Choroidal Neovascularization (CNV) size

  12 weeks

• Change in Central Retinal Thickness

  12 weeks

Study Arms (1)

CM082 Tablet

EXPERIMENTAL

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

Drug: CM082

Interventions

CM082 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).

Also known as: X-82

CM082 Tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

vorolanib

Study Officials

• Youxin Chen

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: December 18, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

CN (1)