| CTRI Number |
CTRI/2023/12/060557 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioavailability Study of Two Formulations of Mylan’s Capecitabine Extended-release Tablets to Immediate-release Capecitabine Tablets in Adult Cancer Patients with Advanced or Metastatic Breast Cancer, Stage III Colon Cancer, or Unresectable or Metastatic Colorectal Cancer |
|
Scientific Title of Study
|
Single-Dose Fed Relative Bioavailability Study of Two Formulations of Mylan’s Capecitabine Extended-release Tablets to Immediate-release Capecitabine Tablets in Adult Cancer Patients with Advanced or Metastatic Breast Cancer, Stage III Colon Cancer, or Unresectable or Metastatic Colorectal Cancer Receiving a Capecitabine Dose of 2000 mg/m2/day or 2500 mg/m2/day |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CAPE-TBR-1003 Version No. 1.1 dated 16/Jun/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV 6th Floor Sardar Patel Ring Road Opp Apple Woods Near Shantipura circle Ahmedabad India
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV 6th Floor Sardar Patel Ring Road Opp Apple Woods Near Shantipura circle Ahmedabad India
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV 6th Floor Sardar Patel Ring Road Opp Apple Woods Near Shantipura circle Ahmedabad India
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
|
Source of Monetary or Material Support
|
| Mylan Pharmaceuticals Inc.
3711 Collins Ferry Road
Morgantown, WV 26505, USA
|
|
|
Primary Sponsor
|
| Name |
Mylan Pharmaceuticals Inc. |
| Address |
3711 Collins Ferry Road Morgantown, WV 26505, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Velavan |
ERODE Cancer Centre |
1/393 Velvan nagar Perundurai road Thindal Erode-638012 Tamil Nadu India
Erode
TAMIL NADU |
9842334222
kvels@rediffmail.com |
| Dr Lagudu Perraju Bhaskar Bhuvan |
HCG Cancer Centre |
Plot no. 10, survey no. 13P, APIIC health city, Arilova, chinagadili, Vishakhapatnam, Andhra Pradesh, 530040, India
Visakhapatnam
ANDHRA PRADESH |
9154144100
drbhaskarbhuvan.lp@hcgel.com |
| Dr Raj Nagarkar |
HCG Manavata Cancer Centre |
Behind Shivang Auto, Mumbai Naka, Nashik - 422002, Maharashtra, India
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Anil Kumar MR |
Oncoville Cancer Hospital and Research Centre |
No 4 , 80 ft. road, 7th block, Naagarabhaavi, 2nd Stage, Bangalore, Karnataka - 560072, India
Bangalore
KARNATAKA |
9739808502
dranil.onco@gmail.com |
| Dr Rajender Singh Arora |
Sujan Surgical Cancer Hospital and Research Centre |
52 B, Shankar nagar main road, Amravati- 444605, Maharashtra, India
Amravati
MAHARASHTRA |
9823097573
dr_rsarora@rediffmail.com |
| Dr Deepak Kumar Singh |
Swami Har Shankaranand Ji Hospital and Research Center |
N 8/237 BHU Road Near Bhikaripur Crossing Opposite Union Bank of India B.H.U Sundarpur Newada Varanasi Uttar Pradesh-221004 India
Varanasi
UTTAR PRADESH |
9450428608
deepakbhu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Amravati Ethics Committee |
Approved |
| IEC - Erode Cancer Centre |
Approved |
| Independent EC- Namaste Integrated Services |
Approved |
| Institutional Ethics Committee HCG Cancer Centre |
Approved |
| Institutional Ethics Committee of OCH and RC |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Treatment A- Test Drug
Capecitabine Extended-release Tablets, 150 mg
Capecitabine Extended-release Tablets, 1000 mg
|
Dose: 2000 mg/m2 or 2500 mg/m2 dose
Route of Administration: Oral,
Total Duration of Therapy: 21 Days Cycle.
|
| Intervention |
Treatment B- Test Drug
Capecitabine Extended-release Tablets, 150 mg Capecitabine Extended-release Tablets, 1000 mg |
Dose: 2000 mg/m2 or 2500 mg/m2 dose
Route of Administration: Oral
Total Duration of Therapy: 21 Days Cycle.
|
| Comparator Agent |
Treatment C- Reference Drug
Capecitabine Tablets, 150 mg
Capecitabine Tablets, 500 mg
|
Dose: 1000 mg/m2 or 1250 mg/m2 dose capecitabine
Route of Administration: Oral
Total Duration of Therapy: 21 Days Cycle.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are receiving stable doses of capecitabine as a single agent for advanced or metastatic breast cancer, adjuvant treatment of colon cancer, or for unresectable or metastatic colorectal cancer.
2. Patients must have completed at least one 21-day cycle of capecitabine.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
4. Age between 18 and 65 years
5. Sex: Females of non-childbearing potential and Males
|
|
| ExclusionCriteria |
| Details |
1. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
2. Individuals with rapidly progressing disease, especially with visceral organ involvement.
3. Individuals requiring a change in dose or regimen of either capecitabine.
4. History of unstable or clinically significant gastrointestinal disease, including a history of chronic diarrhea, inflammatory bowel disease, unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting).
5. History of unstable or clinically significant cardiovascular disease, hepatic, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or other malignancies.
6. Subjects receiving capecitabine for the treatment of gastric, esophageal or gastroesophageal junction cancer or pancreatic cancer.
7. ECOG performance status ≥ 3
8. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2
9. Donation or loss of blood or plasma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relative bioavailability of two extended-release formulations of Mylan’s Capecitabine Extended-release Tablets following a single, oral dose of 2500 mg/m2/day or 2000 mg/m2 dose to reference immediate-release Capecitabine Tablets following a single oral dose of 1250 mg/m2 or 1000 mg/m2 will be evaluated by comparison of various pharmacokinetic parameters derived from the plasma concentration time curves (e.g. AUCL, AUCINF, and CPEAK) of capecitabine. |
PK sampling: From pre-dose till 24 hours in each period administration.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety & tolerability of Capecitabine Extended-release Tablets in cancer patients |
Safety & tolerability of Capecitabine Extended-release Tablets in cancer patients will be assessed from Screening till day 12 (End of study). |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2023 |
| Date of Study Completion (India) |
24/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A
single dose pharmacokinetic study will be performed which will compare two
formulations of Mylan’s Capecitabine Extended-release Tablets, 150 mg &
1000 mg to immediate-release Capecitabine Tablets, 150 mg & 500 mg (Reference
product), under fed conditions in adult cancer patients with advanced or
metastatic breast cancer, stage III colon cancer, or unresectable or metastatic
colorectal cancer receiving a dose of capecitabine of 2500 mg/m2/day
or 2000 mg/m2 dose. |