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Safety and Tolerability of Oral CM082 in Patients With wAMD

Primary Purpose

Age-Related Macular Degeneration

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

CM082

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography (FA) and OCT.
Patients with either no previous anti-VEGF therapy or prior anti-VEGF therapy with the discontinuation time is at least 5 drug half-lives.
ETDRS BCVA 20/400 to 20/32 in the study eye(s).
Adequate bone marrow, hepatic, and renal functions.
Willing to sign the ICF and comply with the study protocol.

Exclusion Criteria:

Patients with Polypoidal Choroidal Vasculopathy (PCV) as evidenced on Indocyanine Green Angiography (ICG).
Geographic atrophy involving the foveal center in the study eye.
Previous treatment with photodynamic therapy (PDT), external beam radiation, subfoveal focal laser photocoagulation, submacular surgery or transpupillary thermotherapy.
CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia.
Any significant disease in the study eye that could compromise best-corrected visual acuity.
Clinically significant impaired renal or hepatic function.
Stroke within 12 months of the first dose or transient ischemic attack within 12 months of the first dose.
Symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization, or arterial thrombosis within 6 months of start of study drug, inadequately controlled hypertension, or ventricular tachyarrhythmias requiring ongoing treatment.
QTc≥450 msec or subjects with a history of risk factors for Torsades de Pointes or other severe ECG abnormalities which are clinically relevant.
Trabeculectomy or aqueous shunt or valve in the study eye.
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.
Women of childbearing age who are pregnant, breast-feeding or not using medically acceptable contraception; males who are unwilling to take adequate contraceptive measures.
Need to take any medicine that is a strong inhibitor or inducer of CYP3A4.

Sites / Locations

Renmin Hospital of Wuhan University, Hubei General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CM082 Tablet

Arm Description

Code Name: CM082 Tablet Other Name: X-82 Dosage and Administration: 25/50mg BID, P.O., two-week on/two-week off in four-week cycles until disease progression or unacceptable toxicity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Best-Corrected Visual Acuity (BCVA)

Change from baseline in mean BCVA (ETDRS)

Change in Choroidal Neovascularization (CNV) size

Change from baseline in mean CNV size (OCTA, FA/ICG)

Change in Central Retinal Thickness

Change from baseline in mean central retinal thickness (OCT)

Change in ERG

Change from baseline in ERG

Proportion Who Develop CNV in the Unaffected Fellow Eye

Diagnosis by FA

Full Information

NCT ID

NCT03710863

First Posted

October 15, 2018

Last Updated

January 8, 2020

Sponsor

AnewPharma

Collaborators

Renmin Hospital of Wuhan University

1. Study Identification

Unique Protocol Identification Number

NCT03710863

Brief Title

Safety and Tolerability of Oral CM082 in Patients With wAMD

Official Title

Phase 2 Study of Intermittent Oral Dosing of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 22, 2018 (Actual)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AnewPharma

Collaborators

Renmin Hospital of Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With wAMD.

Detailed Description

This is a multicenter, open-label, single-arm, phase II Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with wAMD. 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 twice daily for two weeks followed by two weeks off in four-week cycles. There are two dose levels, 25mg BID and 50mg BID. In part 1, the starting dose of 25mg BID(n=8) will be increased by 100% to the maximum dose of 50mg BID(n=8) if the number of patients who experience dose-limiting toxicities is less than 2 during the first cycle. In part 2, based on the relevant data from the dose escalation study, an expanded enrollment study was conducted at a safe and effective dose.Per dose group will enroll 12-24 patients. All patients will take CM082 until disease progression or unacceptable toxicity. The assessment of the safety and efficacy will be done every four weeks from 2nd-6th cycle and every 12 weeks after. Also, single/multiple dose pharmacokinetics in these patients will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CM082 Tablet

Arm Type

Experimental

Arm Description

Code Name: CM082 Tablet Other Name: X-82 Dosage and Administration: 25/50mg BID, P.O., two-week on/two-week off in four-week cycles until disease progression or unacceptable toxicity

Intervention Type

Drug

Intervention Name(s)

CM082

Other Intervention Name(s)

X-82

Intervention Description

Subjects will receive CM082 orally twice daily for two weeks followed by two weeks off in four-week cycles. The starting dose of 25mg BID will be increased by 100% to the maximum dose of 50mg BID.The treatment period is tentatively set at 1 year.

Primary Outcome Measure Information:

Title

Dose-Limiting Toxicity(DLT)

Description

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.

Time Frame

the first cycle(the first four weeks)

Secondary Outcome Measure Information:

Title

Change in Best-Corrected Visual Acuity (BCVA)

Description

Change from baseline in mean BCVA (ETDRS)

Time Frame

8 weeks

Title

Change in Choroidal Neovascularization (CNV) size

Description

Change from baseline in mean CNV size (OCTA, FA/ICG)

Time Frame

8 weeks

Title

Change in Central Retinal Thickness

Description

Change from baseline in mean central retinal thickness (OCT)

Time Frame

8 weeks

Title

Change in ERG

Description

Change from baseline in ERG

Time Frame

8 weeks

Title

Proportion Who Develop CNV in the Unaffected Fellow Eye

Description

Diagnosis by FA

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography (FA) and OCT. Patients with either no previous anti-VEGF therapy or prior anti-VEGF therapy with the discontinuation time is at least 5 drug half-lives. ETDRS BCVA 20/400 to 20/32 in the study eye(s). Adequate bone marrow, hepatic, and renal functions. Willing to sign the ICF and comply with the study protocol. Exclusion Criteria: Patients with Polypoidal Choroidal Vasculopathy (PCV) as evidenced on Indocyanine Green Angiography (ICG). Geographic atrophy involving the foveal center in the study eye. Previous treatment with photodynamic therapy (PDT), external beam radiation, subfoveal focal laser photocoagulation, submacular surgery or transpupillary thermotherapy. CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia. Any significant disease in the study eye that could compromise best-corrected visual acuity. Clinically significant impaired renal or hepatic function. Stroke within 12 months of the first dose or transient ischemic attack within 12 months of the first dose. Symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization, or arterial thrombosis within 6 months of start of study drug, inadequately controlled hypertension, or ventricular tachyarrhythmias requiring ongoing treatment. QTc≥450 msec or subjects with a history of risk factors for Torsades de Pointes or other severe ECG abnormalities which are clinically relevant. Trabeculectomy or aqueous shunt or valve in the study eye. 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. Women of childbearing age who are pregnant, breast-feeding or not using medically acceptable contraception; males who are unwilling to take adequate contraceptive measures. Need to take any medicine that is a strong inhibitor or inducer of CYP3A4.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yin Shen, MD

Phone

86-13871550513

yinshen@whu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yin Shen

Organizational Affiliation

Renmin Hospital of Wuhan University

Official's Role

Study Chair

Facility Information:

Facility Name

Renmin Hospital of Wuhan University, Hubei General Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yin Shen, MD

Phone

86-13871550513

yinshen@whu.edu.cn

12. IPD Sharing Statement

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Safety and Tolerability of Oral CM082 in Patients With wAMD

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