| CTRI Number |
CTRI/2023/01/048670 [Registered on: 02/01/2023] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Phase II Study to Evaluate the Safety and Efficacy of OQL011 in hand and foot skin reaction in Cancer Patients. |
|
Scientific Title of Study
|
A Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OQL011B002 Version No. 10.1 dated 19/Jul/2022 |
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 |
| Address |
2nd Floor, Skoda House, Opp. LJ Campus, S.G. Highway, Sarkhej
Ahmadabad
GUJARAT
380054
India |
| Phone |
9637555304 |
| Fax |
9726434204 |
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
2nd Floor, Skoda House, Opp. LJ Campus, S.G. Highway, Sarkhej
GUJARAT
380054
India |
| Phone |
9637555304 |
| Fax |
9726434204 |
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
2nd Floor, Skoda House, Opp. LJ Campus, S.G. Highway, Sarkhej
GUJARAT
380054
India |
| Phone |
9637555304 |
| Fax |
9726434204 |
| Email |
sandeep.singh@cbccusa.com |
|
|
Source of Monetary or Material Support
|
| OnQuality Pharmaceuticals (USA) LLC,
7437 Richmond Pl, St. Louis, Missouri 63143, USA
|
|
|
Primary Sponsor
|
| Name |
OnQuality Pharmaceuticals (USA) LLC |
| Address |
7437 Richmond Pl, St. Louis, Missouri 63143, USA
E-mail: juegang.ju@onqualityrx.com |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
United States of America
China
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lovenish Goyal |
Aadhar Health Institute |
Tosham Road, Near South Bypass Crossing Hisar-125005, Haryana, India
Hisar
HARYANA |
9729991333
drlovenish@gmail.com |
| Dr Rajnish Nagarkar |
HCG Manavata Cancer Centre |
Behind Shivang Auto, Mumbai Naka, Nashik - 422002, Maharashtra, India
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Santhosh Vandanasetti |
Kailash Cancer Hospital and Research Center |
Muniseva Ashram, Goraj, Waghodia – 391760, Vadodara, Gujarat, India
Vadodara
GUJARAT |
9427423693
vandanasetti.santhosh@greenashram.org |
| Dr Shanti Prakash Shrivastav |
Kiran Multi super Speciality Hospital and Research Centre |
Nr. Sumul Dairy, Surat -395004, Gujarat, India
Surat
GUJARAT |
9824196710
Sp.Shrivastav@kiranhospital.com |
| Dr Kshitij Joshi |
Mumbai Oncocare Centre |
2nd Floor, Majithia Apartments, Gods Gift Premises Co. Op. Society Ltd., Above Irla Nursing Home, S V Road, Vile Parle (W), Mumbai – 400 056, Maharashtra, India
Mumbai
MAHARASHTRA |
9687619991
drkshitijjoshi@mocindia.co.in |
| Dr Minish Jain |
Noble Hospital, Pvt. Limited |
153, Magarpatta City Road, Hadapsar, Pune-411013, Maharashtra, India
Pune
MAHARASHTRA |
9823133390
minishjain009@gmail.com |
| Dr Anil kumar MR |
Oncoville Cancer Hospital and Research Center |
No 4, 80 Ft Road, 7th Block , Nagarbhavi,
2nd stage , Bangalore -560072, Karnataka, India
Bangalore
KARNATAKA |
9739808502
dr.anil.onco@gmail.com |
| Dr Pankaj Goyal |
Rajiv Gandhi Cancer Institute and Research Centre |
Rohini Sector-5,
Rohini west Metro station,
Delhi – 110085, India
West
DELHI |
9711996969
pankaj155@yahoo.com |
| Dr Mukesh C Arya |
S. P. Medical College and A. G. of Hospitals |
Dept. of Urology, Uro-Science Center, S. P. Medical College & A. G. of Hospitals, Bikaner -334001, Rajasthan, India
Bikaner
RAJASTHAN |
9414138782
mcarya@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Adhar Institutional Ethics Committee |
Approved |
| Ethics Committee, S. P. Medical College, Bikaner |
Approved |
| IEC-KCHRC |
Approved |
| Institutional Ethics Committee of OCH and RC |
Approved |
| Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
| Kiran Hospital Ethics Committee |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
| Mumbai Oncocare Centre Institutional Ethics Committee |
Approved |
| Noble Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L271||Localized skin eruption due to drugs and medicaments taken internally, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Part II:
Investigational Treatment: OQL011 dose I (0.2% w/w), dose II (0.1% w/w), and dose III (0.5% w/w) 30 g ointment (equivalent active ingredient: 60 mg nitroglycerin, 30 mg nitroglycerin for dose II, and 150 mg nitroglycerin for dose III).
|
Dose: OQL011 dose I (0.2% w/w), dose II (0.1% w/w), and dose III (0.5% w/w)
Frequency: 3 times a day
Route of administration: Topical
Duration of Therapy: 28 Days
|
| Comparator Agent |
Vehicle ointment 30 g ointment (equivalent active ingredient: 0 mg) |
Dose: OQL011 dose I (0.2% w/w), dose II (0.1% w/w), and dose III (0.5% w/w)
Frequency: 3 times a day
Route of administration: Topical
Duration of Therapy: 28 Days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The subjects will be included in the study based on the following criteria:
1) Patient must be age ≥ 18 years.
2) Patient must have a confirmed cancer diagnosis for which VEGFRi treatment is indicated, and must be currently under VEGFRi-based anticancer therapy with stable dosage for ≥ 1 week. This treatment may be VEGFRi monotherapy or VEGFRi-based combination therapy, so long as it does not include prohibited therapies.
3) Patient must have shown signs of HFSR that meet the IGA-HFSR criteria of grade 3 or higher.
4) Patient on pain medications is allowed provided they have been on stable dosage in the past 1 week and is going to continue on the same dose.
5) Patient is able to use topical medications and complete questionnaires reliably.
6) ECOG performance score ≤ 2
7) Patient must have the ability to understand and the willingness to sign a written informed consent prior to study entry.
|
|
| ExclusionCriteria |
| Details |
The subjects will be excluded from the study based on the following criteria:
1) Patient with unresolved hand-foot skin disorders (CTCAE grade 2 or higher) due to other medications within 4 weeks prior to study entry.
2) Patient who is using other topical medications in the hands or feet area and cannot stop such usage ahead of randomization.
3) Patient who is on concurrent cancer medications that can cause skin reactions in hands or feet, such as capecitabine, pegylated liposomal doxorubicin, 5-fluorouracil, dabrafenib, vemurafenib, doxorubicin, docetaxel, cytarabine.
4) Patient who is under uncontrolled intercurrent illness including, but not limited to, inadequately controlled nausea, vomiting, diarrhea or other conditions which may contribute to hypovolemia, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, uncontrolled hypotension (including orthostatic hypotension) or hypertension, cardiac arrhythmia, or psychiatric illness and social situations that would limit compliance with study requirements.
5) Patient who has contraindication with the active compound, including severe anemia, increased intracranial pressure, known hypersensitivity.
6) Patient who has other skin disorders that will affect the efficacy evaluation on hands and feet area, including but not limited to, tinea of feet and hands, hand/foot eczema, palmoplantar pustulosis, palmoplantar keratosis, acrodermatitis continua etc.
7) Patient who used of phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil, vardenafil, and tadalafil within past 7 days.
8) Patient with significantly abnormal lab test:
Inadequate hematologic function as indicated by:
• Absolute neutrophil counts (ANC) ≤1,000/mm3
• Hemoglobin (Hgb) ≤8.0 g/dL
• Platelet count ≤75,000/mm3
• PT or PTT >1.5 x ULN (if patients on anticoagulants: PT INR >3.5 x ULN).
Inadequate renal and liver function as indicated by:
• Albumin <2.8g/dL
• Total bilirubin ≥1.5 x ULN (or ≥2.5 x ULN for patients with Gilbert’s syndrome)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≥3 x ULN (or ≥5 x ULN for patients with liver cancer)
• Creatinine >2.0 x ULN
9) Pregnant or nursing women.
10) Women of childbearing potential who are unwilling to comply with contraceptive requirements. Highly effective contraception which include two forms of birth control method (i.e., a hormonal method plus a barrier method) is advised for at least 2 weeks prior to study treatment and during study participation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Part 2:
To evaluate the efficacy of OQL011 doses I-III compared to vehicle for the treatment of HFSR as measured by the proportion of patients achieving IGA- HFSR grade 0 or 1 at Week 2.
|
Proportion of patients who have achieved IGA- HFSR grade 0 or 1 at Week 2. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Part 2:
To evaluate the efficacy of OQL011 doses I-III compared to vehicle for the treatment of HFSR as measured by the proportion of patients achieving IGA-HFSR grade 0 or 1 at Week 4.
To evaluate the efficacy of OQL011 doses I-III compared to vehicle for the treatment of HFSR as measured by the proportion of patients achieving at least 2 grade improvement in IGA-HFSR at Weeks 2 and 4.
To evaluate the efficacy of OQL011 doses I-III versus vehicle measured by NCI CTCAE v5.0 for PPE, HF-QoL and daily pain score (NPRS) at Week 2 and Week 4.
To compare the efficacy of OQL011 among doses I, II, and III, as well as to evaluate by dose level the exposure-response relationship of OQL011.
To evaluate the safety of OQL011 doses I-III versus vehicle in patients with HFSR.
To evaluate PK of OQL011 doses I-III in patients with HFSR.
To evaluate compliance in using VEGFRi between OQL011 doses I-III, or vehicle control per patient diary.
|
Proportion of patients who have achieved at least 2 grade improvement in IGA-HFSR at Weeks 2 and 4.
Proportion of patients who achieved clear (0) or almost clear (1) as measured by IGA-HFSR scale at Week 4.
Proportion of patients who have achieved NCI CTCAE v5.0 for PPE grade 0 or 1 at Week 2 and at Week 4.
Change from baseline in HF-QoL total score at Week 2 and at Week 4.
Change from baseline in patient reported pain (NPRS) at Week 2 and at Week 4.
|
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="35"
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 |
|
Date of First Enrollment (India)
|
02/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/01/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Phase II Study to Evaluate the Safety and Efficacy of
OQL011 on VEGFR inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
Primary Objective:
Part 2:
To evaluate the efficacy of OQL011 doses I-III compared to vehicle for
the treatment of HFSR as measured by the proportion of patients achieving IGA-
HFSR grade 0 or 1 at Week 2.
Secondary Objective:
Part 2:
To evaluate the efficacy of OQL011 doses I-III compared to vehicle for
the treatment of HFSR as measured by the proportion of patients achieving
IGA-HFSR grade 0 or 1 at Week 4.
To evaluate the efficacy of OQL011 doses I-III compared to vehicle for
the treatment of HFSR as measured by the proportion of patients achieving at
least 2 grade improvement in IGA-HFSR at Weeks 2 and 4.
To evaluate the efficacy of OQL011 doses I-III versus vehicle measured
by NCI CTCAE v5.0 for PPE, HF-QoL and daily pain score (NPRS) at Week 2 and
Week 4.
To compare the efficacy of OQL011 among doses I, II, and III, as well as
to evaluate by dose level the exposure-response relationship of OQL011.
To evaluate the safety of OQL011 doses I-III versus vehicle in patients
with HFSR.
To evaluate PK of OQL011 doses I-III in patients with HFSR.
To
evaluate compliance in using VEGFRi between OQL011 doses I-III, or vehicle
control per patient diary. |