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CTRI Number  CTRI/2021/07/034694 [Registered on: 08/07/2021] Trial Registered Prospectively
Last Modified On: 13/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR inhibitor-Associated HFSR 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  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
OQL011B002  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  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India

Ahmadabad
GUJARAT
382210
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 LLP  
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India

Ahmadabad
GUJARAT
382210
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 LLP  
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India

Ahmadabad
GUJARAT
382210
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  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India
United States of America  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lovenish Goyal  Aadhar Health Institute  Near South Bypass Crossing, NH10-Tosham Rd Connection Rd, Hisar, Haryana - 125005, india
Hisar
HARYANA 		 9896539142

drlovenish@gmail.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 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Adhar Institutional Ethics Committee  Approved 
I.E.C. – Mumbai Oncocare Centre Institutional Ethics Committee  Submittted/Under Review 
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  Submittted/Under Review 
Noble Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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-I: Investigational Treatment: OQL011(Dose I) ointment Part II: Investigational Treatment: OQL011(Dose II and Dose III) ointment   Part-I Investigational Treatment: OQL011(Dose I) ointment (0.2% w/w) 30 g (equivalent active ingredient: 60 mg). Part II: Investigational Treatment: OQL011(Dose II and Dose III) ointment (0.5% w/w and 0.1% w/w) 30 g (equivalent active ingredient: 150 mg and 30 mg). Frequency: 3 times a day Route of administration: Topical & Duration of therapy: 42 Days 
Comparator Agent  Reference Therapy: Vehicle ointment  NA 
 
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 greater than or equal to 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 greater than or equal to 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 NCI CTCAE v5.0 Term Palmar-plantar Erythrodysesthesia Syndrome criteria as grade 2 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 at the same dosage.
5) Patient is able to use topical medications and complete questionnaires reliably.
6) ECOG performance score less than or equal to 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 or 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 greater than7 days 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, ramucirumab and bevacizumab.
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, handperfoot 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) less than or equal to1,000 per mm3
• Hemoglobin (Hgb) less than or equal to8.0 g per dL
• Platelet count less than or equal to75, 000 per mm3
• PT or PTT greater than 1.5 x ULN (if patients on anticoagulants: PT INR greater than3.5 x ULN).
Inadequate renal and liver function as indicated by:
• Albumin less than 2.8g per dL
• Total bilirubin greater than or equal to 1.5 x ULN (or greater than or equal to2.5 x ULN for patients with Gilbert’s syndrome)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase greater than or equal to3 x ULN (or greater than or equal to5 x ULN for patients with liver cancer)
• Creatinine greater than 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   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Part 1:
To evaluate the efficacy of OQL011 dose I versus vehicle measured by the proportion of patients achieving NCI CTCAE v5.0 for PPE grade 0 or 1 by Week 3.

Part 2:
To evaluate the efficacy of OQL011 dose II and dose III compared to vehicle for the treatment of HFSR as measured by the proportion of patients achieving NCI CTCAE v5.0 for PPE grade 0 or 1 by Week 3.
 		 Nine patients will go through a PK study. Blood samples will be taken on Day 0 at pre-dose and 5 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hour, 2 hour, 4 hour, 6 hour, 8 hour, after the first application of investigational drugs.  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of OQL011 dose II and dose III versus vehicle measured by IGA-i, IGA-c, NCI CTCAE v5.0 for PPE, HF-QoL, daily pain score (VAS) by Week 3 and Week 6.
To evaluate the safety of OQL011 dose II and dose III versus vehicle in patients with HFSR.
To evaluate PK of OQL011 dose II and dose III in patients with HFSR
 		 Fifteen patients will go through a PK study. PK samples will be collected on Day 0 at pre-dose, 5 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hour, 2 hour, 4 hour, 6 hour, 8 hour, after the first application of investigational drugs.  
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="70" 
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)   15/07/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/08/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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 (Numerical Pain Rating Scale (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.

 

Exploratory objective:

Part 2: To evaluate compliance in using OQL011 dose I-III, or vehicle control per patient diary.

 
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