Appendix-C3 CT-Application-Form How to Sign Up on C3 CT-Application Form PDF

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Download Appendix-C3 CT-Application-Form How to Sign Up on C3 CT-Application Form PDF

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Appendix C3 FDA-CRS Form 3.0

CLINICAL TRIAL APPLICATION FORM CLINICAL TRIAL INFORMATION

Full Title of the Clinical Trial

Abbreviated Title of the Clinical Trial Phase of Clinical Trial to be Conducted

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49) Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTEB49) □ Phase I

□ Phase II

 □ Phase III

 □

Table of Contents (FDA-CRS Form 1.0)

 □

Cover Letter (FDA-CRS Form 2.0)

 □

□ Phase IV

□ Others (Specify)____ _

Investigational Product (IP) and Ancillary Supplies Information (FDA-CRS Form 4.0)

Contents

 □  □  □  □  □  □

 □  □  

Protocol Version Number Name/Code of Investigational Product

Proof of Payment Clinical Trial Protocol Good Clinical Practice (GCP) Certificate and Curriculum Vitae (CV) of Principal Investigator (PI) for each Trial Site Informed Consent Form Pharmaceutical Data Good Manufacturing Practice (GMP) Certificate and/or Evidence of GMP compliance

□

Shipping Condition for IP and trial related materials;

□

Labeling Materials

 □ Clinical Trial Protocol Number

Import License (IL) Application Form (FDA-CRS Form 5.0) Letter of Authorization (FDA-CRS Form 6.0)

Investigator’s Brochure

MK-3475-B49 (CT identifier: NCT04895358) Protocol Version 5.0 Pembrolizumab MK-3475

Proposed Indication for Use

Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer

Target Population/ Characteristics of Trial Subjects

800/Breast cancer patients (Male and Female) (18 Years and older)

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Total Number of Subjects in the Philippines

8 August 15, 2021

Expected Start Date Expected End Date

January 21, 2028

STUDY SITES If the study will be conducted in more than one study site, assign a sequential number (e.g. Site1, Site2, Site 3 and so on) for each study site. Provide tabulation on a separate sheet when necessary.

Site Sequential Number

Site 1

Site 2 Site 3

Site 4

Site 5

Name of Study Site

University Cancer & Blood Center, LLC ( Site 0032) Orchard Healthcare Research Inc. ( Site 0037) McFarland Clinic, PC ( Site 0041) Greater Baltimore Medical CenterMedical Oncology/Hematology ( Site 0062) University of Massachusetts Medical SchoolDivision of Hematology/Oncology ( Site 0052)

Principal Investigator

Contact Details of PI (Mobile No. & Email Address)

Study Coordinator

706-353-2990

Study Coordinator

847-568-9930

Study Coordinator

515-956-4159

Study Coordinator

443-849-3051

Study Coordinator

508-856-2424

SPONSOR INFORMATION Name of Sponsor

Merck Sharp & Dohme (I.A.) LLC

LTO Number

CDRR-NCR-S-16 / LTO-3000006624320

Address

26/F Philamlife Tower, 8767 Paseo de Roxas, Makati, 1226 Metro Manila

Contact Information

Is any part of the clinical trial to be conducted by a Contract Research Organization?

Telephone No.

+632-87849523

Mobile No.

09875462564

E-mail Address

[email protected]

 Yes

□

Name of CRO:

Type of Organization:

IVY MONIQUE C. GATOC__

No

________________________

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LTO No.: 1234567852 Attach Letter of Authorization (FDA-CRS Form 6.0)

Also attach a copy of the Signed Agreement between the study Sponsor and CRO

Person responsible for monitoring the conduct and progress of the clinical trial

Name

Priscila Perez

Designation

Merck Sharp & Dohme (I.A.) LLC 26/F Philamlife Tower , 8767 Paseo de Roxas, Makati City, 1226 Philippines

Telephone No.

+632-456-1980

Mobile No.

094857392

E-mail Address

[email protected]

APPLICANT STATEMENT I/We hereby confirm that: -

The above information given is true, correct and complete, and that all relevant information are provided

-

I/We shall abide and adhere by the FDA Regulations

-

I/ We shall not initiate the above-named trial until approval both from the responsible Research Ethics Committee (REC) of the trial site/s and the FDA are obtained.

-

I/ We will declare the effective date of commencement of the trial and submit necessary reports to the to the FDA and REC concerned as soon as available

-

All manufacturing and assembly operations are carried out under Good Manufacturing Practice (GMP) conditions

-

I/ We shall inform FDA of any changes to the information submitted in the application as required

-

The study will be conducted in compliance with the protocol, FDA requirements, and the principles of Good Clinical Practice

-

I/ We undertake to indemnify the Government/the Hospital against any and all actions, claims or proceedings in respect of any injury to or death of any person whomsoever arising out of or in connection with the carrying out of the clinical trial.

Name of applicant

atoc

Signature Designation Organization

rganization (Phils.) Page 3 of 4

Telephone No. Contact information

Date of submission

Mobile No.

09667615897

E-mail Address

[email protected]

10/19/2021

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