CTRI/2025/04/083831 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On:
29/07/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
This acceptability Study of Cyclophosphamide Powder for Oral Solution 30mg/mL in Paediatric Cancer Patients who are on Oral Cyclophosphamide Treatment
Scientific Title of Study
A prospective, Multicenter, Open-label, Non-randomized, Acceptability Study of Cyclophosphamide Powder for Oral Solution 30 mg/ mL, (Manufactured by Intas Pharmaceuticals Limited, India) in Paediatric Cancer Patients who are on Oral Cyclophosphamide Treatment
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol: 72189805, Version: 5.0, Date: 25 May 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Naman Shah
Designation
Senior General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Ltd, Corporate Office, Near Sola Bridge, S.G. Highway, Thaltej,
Ahmedabad, Gujarat, India - 380054
Primary Sponsor
Name
Intas Pharmaceuticals Limited
Address
Corporate House, Near Sola Bridge, S.G. Highway, Thaltej,
Ahmedabad, Gujarat, India. Pincode- 380054
Department of Clinical research, Room No. NA, Dr. BRA Institute Rotary Cancer Hospital, IRCH, AIIMS.
New Delhi DELHI
9950985343
samdoc_mamc@yahoo.com
DrSonali Mohapatra
All India Institiute of Medical Sciences
Department of Clinical research, Room No. NA, Sijua, Patrapada, Bhubaneswar, 751019
Khordha ORISSA
9438884061
docsonali17@gmail.com
Dr Chinmay Doctor
Gujrat Cancer Research Institute
Department of Clinical research, Room No. NA, Clinical Trial Wing, Room No. C - 112, 1st floor, The gujarat cancer & Research Institute , MP Shah Cancer hospital, Civil Hospita Campus, Asrawa - 380016 Ahmadabad GUJARAT
7567096603
chinmay.doctor@gcriindia.org
Dr Arun Seshachalam
GVN Riverside Multispeciality Hospital
Department of Clinical research, Room No. NA, Thimmarayasamuthiram Trichy-Chennai NH-45, Thiruvanaikoil, 620005
Tiruchirappalli TAMIL NADU
9786220191
arunonco@gmail.com
Dr Rajnish Nagarkar
HCG Manavata Cancer Centre
Department of Clinical research, Room No. NA, HCG Manavata Cancer Centre, Behind Shivang Auto, Mumbai Naka - 422002
Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.cm
Dr Hemant Menghani
Marengo CIMS Hospital
Department of Clinical research, Room No. NA, Plot No. 67/1, Opp. Panchamrut Bunglows, Nr. Shukan Mall, Off Science City Road, Sola – 380 060
Ahmadabad GUJARAT
7433811521
hemant.menghani@marengoasia.com
Dr Prachi Jain
Max Superspeciality Hospital
Department of Clinical research, Room No. NA, Vaishali, )A Unit of Crosslay Remedies Limited) W -3, Sector -1 , Vaishali, Ghaziabad- Uttar Pradesh - 201012
Ghaziabad UTTAR PRADESH
8447808611
Prachi.Jain@maxhealthcare.com
Dr PK Chaithanya
MNJ Institute of Oncology & regional cancer Centre
Department of Clinical research, Room No. NA, MNJ Institute of Oncology & regional cancer Centre , 3rd floor , Room No. 11, Red Hills,
Hyderabad TELANGANA
8897199994
mnjiorcchaithnya@gmail.com
Dr Nita Radha Krishnan
Post Graduate Institute of child health
Department of Clinical research, Room No. NA, Indergarhi, Sector 30, Noida, Uttar Pradesh 201310
Gautam Buddha Nagar UTTAR PRADESH
9999041524
nitaradhakrishnan@yahoo.com
Dr Shweta Bansal
Sir H N Relaince Foundation Hospital and Research Centre
Department of Clinical research, Room No. NA, Raja RammohanRoy Road, Prathana Samaj, Girgaon, Mumbai - 400004.
Mumbai MAHARASHTRA
9920266062
Shweta.Bansal@rfhospital.org
Dr Anand KC
Sri Shankara Cancer Hospital and Research Center
Department of Clinical
research, Room No.
NA, 1st Cross, Shankara Matt Premises, Shankarapuram, Basavanagudi, 560004
Bangalore KARNATAKA
ManavataClinicalResearchInstitute Ethics Committee, Dr. Rajnish Nagarkar
Submittted/Under Review
MNJIORCC Ethics Committee, Dr. P.K Chaithanya
Approved
Sri Shankara Cancer Hospital and Research Centre, Dr. Anand K.C
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C00-D49||Neoplasms,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Cyclophosphamide Powder for Oral Solution 30 mg/mL
Dose: 30mg/ml.
Route of Administration: Oral.
Frequency: Once daily monotherapy for 10 consecutive days (5 days per treatment phase) in two consecutive treatment phase. The individual dose should be based on the subject’s body surface area and prescribed according to local clinical practice and guidelines.
Timing of dosing: Preferably in morning and at the same time of the day.
Comparator Agent
NA
NA
Inclusion Criteria
Age From
3.00 Year(s)
Age To
18.00 Year(s)
Gender
Both
Details
1) Male or female paediatric subjects from 3 to less than 18 years at the time of signing consent.
2) Subjects with documented histologically or cytologically confirmed malignant disease requiring cyclophosphamide treatment (oral cyclophosphamide as monotherapy or as part of combination therapy) and who are already receiving Cyclophosphamide by dissolving/crushing the tablet.
3) Able to give assent for participation in the trial based on their mental ability/actual age. Moreover parents/care givers/legally-authorized representatives (LAR) have to give written informed consent for respective subjects. Such parents/care givers/LARs should be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. For illiterate individuals, verbal consent should be obtained in the presence of and be countersigned by a literate witness.
4) If subjects are already on radiotherapy, a gap of 28 days (4 weeks) must be maintained between the last day of radiotherapy and the day of screening.
5) A life expectancy of at least 3 months.
6) Recovery from any toxic effects of previous chemotherapy as judged by the Investigator at the time of screening.
7) Able to intake food and medication at the time of screening.
8) Karnofsky Performance Score greater than 50 for subjects greater than or equal to 16 to less than 18 years of age OR Lansky score greater than 50 for subjects greater than 3 to less than 16 years of age.
9) Adequate bone marrow function, renal function and hepatic function at the screening visit.
10) A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 12 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 12 months after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. • A WOCBP must have a negative serum pregnancy test at screening; and negative urine pregnancy test before the first dose of study intervention at baseline visit. • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study intervention are located in Appendix 8.2.8. • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
ExclusionCriteria
Details
1) Known hypersensitivity to study drugs or any of ingredients of the formulation.
2) Subject in need of receiving the study medication via nasogastric tube.
3) Any other condition that, in the investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
4) The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of investigational medicinal product for the current study. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
5) Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
6) Female subjects of childbearing potential with positive serum beta-human chorionic gonadotropin (beta-hCG) at the time of screening.
7) Pregnant or lactating subject.
8) Subjects or their caregivers unable to carry out study assessments and comply with the requirements of the protocol.
9) Currently known active case of positive for COVID-19 infection.
10) Active ulceration of the oral mucosa.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the overall acceptability of Cyclophosphamide Powder for Oral Solution
Overall acceptability will be assessed according to the rating scales, within 10 minutes after dosing
Secondary Outcome
Outcome
TimePoints
To evaluate the taste and smell acceptability of Cyclophosphamide Powder for Oral Solution
Taste and smell acceptability will be assessed according to the rating scales, within 10 minutes after dosing
Target Sample Size
Total Sample Size="20" Sample Size from India="20" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2/ Phase 3
Date of First Enrollment (India)
14/04/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="1" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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
This is a acceptability study which will be conducted in Paediatric Cancer Patients who are on Oral Cyclophosphamide Treatment to evaluate the overall acceptability and evaluate the taste and smell acceptability of Cyclophosphamide Powder for Oral Solution.