| CTRI Number |
CTRI/2024/08/072373 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate safety of LNP8701 in patients with different types of Metastatic solid cancers |
|
Scientific Title of Study
|
A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of LNP8701 in Subjects with Metastatic Solid Tumors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chirag Shah |
| Designation |
Vice President |
| Affiliation |
Lupin Ltd. |
| Address |
1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
412115
India |
| Phone |
02066749068 |
| Fax |
|
| Email |
chiragshah@lupin.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Shah |
| Designation |
Vice President |
| Affiliation |
Lupin Ltd. |
| Address |
1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
412115
India |
| Phone |
02066749068 |
| Fax |
|
| Email |
chiragshah@lupin.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Kardekar |
| Designation |
Assistant Director |
| Affiliation |
Lupin Ltd. |
| Address |
1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
412115
India |
| Phone |
02066747372 |
| Fax |
|
| Email |
neelamnkardekar@lupin.com |
|
|
Source of Monetary or Material Support
|
| Lupin Limited, Lupin Research Park,46A/47A, Village Nande, Taluka Mulshi, Pune 412115,
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Lupin Limited |
| Address |
Gate No: 1156, Village-Ghotawade, Taluka-Mulshi, Pune. Pin: 412115 Maharashtra, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nilesh Dhamne |
Kolhapur Cancer Centre Pvt. Ltd., |
Kolhapur Cancer Centre Pvt. Ltd., R.S.238, opp. Mayur Petrol Pump, Gokul Shirgaon, Kolhapur, Maharashtra, India 416234
Kolhapur
MAHARASHTRA |
7738245698
dr.nilesh.gmc@gmail.com |
| Dr Anshul Agarwal |
PP Maniya Hospital Private LTD. |
PP Maniya Hospital Private LTD. Mamta Park Society-1, Opp. Dharuka College, Kapodra, Surat, Gujarat- 395006, INDIA
Surat
GUJARAT |
8657068668
anshul.oncology@gmail.com |
| Dr Viraj Lavingia |
Shalby Hospital |
Shalby Hospital, Opp. Karnvati Club, S.G. Highway, Ahmedabad-380015, Gujarat, India
Ahmadabad
GUJARAT |
9908711057
drvirajlavingia@gmail.com |
| Dr Satheesh CT |
Spandana Oncology Centre |
Spandana Oncology Centre, #919, New No. 68. 28th Main Road, 9th block, Jayanagar, Bangalore-560068
Bangalore
KARNATAKA |
9242698750
drsatheeshct@gmail.com |
| Dr Ghanashyam Biswas |
Sparsh Hospital & Critical care Pvt. Ltd. |
Sparsh Hospital & Critical care Pvt. Ltd., A/407, Saheed Nagar, Bhubaneshwar-751007, India
Khordha
ORISSA |
9937500878
drgbiswas@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ethics Committee - Shalby Limited |
Approved |
| Institutional Ethics Committee Spandana Oncology Centre |
Approved |
| Institutional Ethics Committee Sparch Hospital and Critical Care Private limited |
Approved |
| Kolhapur Cancer Centre, Insitutional Ethics Committee |
Approved |
| PP Maniya Hospital Ethics Committee PP Maniya Hospital Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
LNP8701 |
50 mg and 10 mg Tablets for
oral administration. LNP8701
will be administered orally in
once daily for 28 days for maximum of 6
cycles |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects ≥18 years of age.
2.Subjects must have a histologically or cytologically confirmed diagnosis of metastatic solid tumors.
3.Subjects with solid tumors must have at least one measurable tumor lesion according to response evaluation criteria in solid tumors (RECIST) v1.1.
Subjects must have an ECOG performance status of 0 or 1.
4.Subjects must have clinical laboratory values that meet the following criteria:
-Absolute neutrophil count ≥1.5 x 109/L
-Platelets ≥100 x 109/L
-Hemoglobin ≥9 g/dL
-Serum bilirubin ≤1.5 x upper limit of normal (ULN)
-Aspartate aminotransferase and alanine aminotransferase ≤3 x ULN in absence of liver metastases; or ≤5 x ULN if the subject has documented liver metastases
5.Subjects with history of disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumor type and disease stage, in the opinion of the investigator.
6.Subjects must have a life expectancy ≥12 weeks in the opinion of the Investigator. |
|
| ExclusionCriteria |
| Details |
1. Subjects with symptomatic central nervous system (CNS)
metastases.
2. History of another primary malignancy except for treated
non-melanoma skin or cervical cancer in situ or ductal cancer in situ.
3. Evidence of clinically significant organ dysfunction.
4. Any major surgery, as determined by the investigator within 30
days of screening.
5. Positive screen test for HIV, Hepatitis B, Hepatitis C.
6. History of any relevant allergy/hypersensitivity to the study drugs
or its excipient
7. Use of concomitant medication that might reasonably influence the
results of the study prior to study drug administration and at any time
during the study.
8. Received any therapy such as chemotherapy, radiotherapy, biologic therapy, immunotherapy, other investigational agent within 30 days or a washout of at least 5 half-lives whichever is long with respect to study drug administration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine Maximum Tolerated Dose (MTD) of LNP8701 |
From baseline till the end of cycle 1 at each dose level MTD will assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of subjects with adverse events (AEs) & serious AEs (SAEs) & PK parameters |
At the end of the treatment (approximately 24 weeks). |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 1 |
|
Date of First Enrollment (India)
|
27/09/2024 |
| 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="3"
Months="0"
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 Phase 1, open label, multi-center study of LNP8701 in subjects with metastatic solid tumors. This study will be a first-in-human study to determine the MTD, to evaluate safety, tolerability, PK and to explore the preliminary efficacy profile of orally administered LNP8701. Also to determine overall response rate (radiological assessment) as per RECIST 1.1 criteria as a monotherapy. To evaluate number of subjects with adverse events and serious adverse events. Number of subjects withdrawn due to related AEs. To check the effect of food on the PK parameters; Cmax, AUC, terminal phase half life. |