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A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (NOVA-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088318
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
OnQuality Pharmaceuticals (USA) LLC

Brief Summary:
Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) treatment in cancer patients. The main purpose of this study is to evaluate the safety and efficacy of OQL011 compared to vehicle ointment in treating patients with moderate to severe VEGFRi-associated HFSR. This study will also identify an optimal dosage for Phase III study and explore the pharmacokinetics profile of OQL011 in HFSR patients.

Condition or disease Intervention/treatment Phase
Hand-Foot Skin Reaction (HFSR) Drug: OQL011 Drug: Vehicle Ointment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: OQL011 Dose I
OQL011, Dose I, ointment, to be applied topically, three times a day, for up to six weeks
Drug: OQL011
OQL011 is an ointment containing active ingredient.

Experimental: OQL011 Dose II
OQL011, Dose II, ointment, to be applied topically, three times a day, for up to six weeks
Drug: OQL011
OQL011 is an ointment containing active ingredient.

Experimental: OQL011 Dose III
OQL011, Dose III, ointment, to be applied topically, three times a day, for up to six weeks
Drug: OQL011
OQL011 is an ointment containing active ingredient.

Vehicle Ointment
Vehicle ointment, to be applied topically, three times a day, for up to six weeks
Drug: Vehicle Ointment
Vehicle ointment is an ointment containing no active ingredient.




Primary Outcome Measures :
  1. Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0 or 1 [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients who have improvement in HFSR severity and achieve clear (0) or almost clear (1) as measured by IGA-i (Investigator-assessed Investigator's Global Assessment) scale [ Time Frame: 3 weeks and 6 weeks ]
    The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.

  2. Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0 or 1 [ Time Frame: 6 weeks ]
  3. Change from baseline in HF-QoL (Hand-Foot Skin Reaction and Quality of Life) Questionnaire total score [ Time Frame: 3 weeks and 6 weeks ]
    HF-QoL questionnaire is comprised of a 20-item symptom domain and an 18-item daily activity domain. Each item is rated on a 5-point scale from 0 (not at all) to 4 (always or extremely) during the previous week. The HF-QoL symptom and daily activity total scores are transformed to a scale of 0 to 100, based on the sum of each unit-weighted item score divided by the maximum score. Higher scores on the HF-QoL indicate worse quality of life or greater symptom burden. (refer to R. T. Anderson et al., The Oncologist 2015;20:831-838)

  4. Change from baseline in patient reported pain using VAS (Visual Analog Scale) [ Time Frame: 3 weeks and 6 weeks ]
    The subject records pain associated with HFSR using 100 mm VAS ranging from "no pain" at 0 mm to "unbearable pain" at 100 mm on the paper VAS.

  5. Proportion of patients who have improvement in HFSR severity and achieve clear (0) or almost clear (1) as measured by IGA-c (Centrally-assessed Investigator's Global Assessment) scale [ Time Frame: 3 weeks and 6 weeks ]
    The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.

  6. Safety assessment by type, incidence and intensity of adverse events [ Time Frame: 6 weeks ]
  7. Plasma concentration of active compound and its derivatives [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be age ≥ 18 years.
  • Patient must have a confirmed cancer diagnosis for which VEGFRi treatment is indicated, and must be currently under VEGFRi-based anti-cancer 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.
  • Patient must have shown signs of HFSR that meet the NCI CTCAE v5.0 - PPE grade 2 or higher.
  • 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.
  • Patient is able to use topical medications and complete questionnaires reliably.
  • Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
  • Patient must have the ability to understand and the willingness to sign a written informed consent prior to study entry.

Exclusion Criteria:

  • Patient with unresolved hand or foot skin disorders (NCI CTCAE v5.0 grade 2 or higher) due to other medications within 4 weeks prior to study entry.
  • Patient who is using other topical medications in the hands or feet area and cannot stop such usage >7 days ahead of randomization.
  • Patient who is using other concurrent cancer medications, such as capecitabine, pegylated liposomal doxorubicin, 5-fluorouracil, dabrafenib, vemurafenib, doxorubicin, docetaxel, cytarabine, ramucirumab and bevacizumab, which may result in hand-foot syndrome (HFS).
  • 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 or hypertension, cardiac arrhythmia, or psychiatric illness and social situations that would limit compliance with study requirements.
  • Patient who has contraindication with the active compound, including severe anemia, increased intracranial pressure, known hypersensitivity.
  • 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.
  • Patient who used phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil, vardenafil, and tadalafil within past 7 days.
  • Patient with significantly abnormal lab test:

    • Inadequate hematologic function as indicated by:

      • Absolute neutrophil counts (ANC) ≤ 1,000 /mm^3
      • Hemoglobin (Hgb) ≤ 8.0 g/dL
      • Platelet count ≤ 75,000 /mm^3
      • 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 < 2.8 g/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.
  • Pregnant or nursing women.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088318


Contacts
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Contact: Mark Webb, PhD +1-801-618-8292 Mark.Webb@OnQualityRx.com
Contact: Johnny Ju, MSc +86-137-6163-6367 Juegang.Ju@OnQualityRx.com

Locations
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United States, California
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Kirsten Bettino, CCRP       kbettino@airesearch.us   
Principal Investigator: Omkar S. Marathe, MD         
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Kirsten Bettino, CCRP       kbettino@airesearch.us   
Principal Investigator: Gregory Gilmore, DO         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Robyn Swing, CCRP       robyn.swing@cuanschutz.edu   
Principal Investigator: Elaine T. Lam, MD         
United States, Connecticut
Yale University - Hospital Recruiting
New Haven, Connecticut, United States, 06519
Contact: Brianna Olamiju       brianna.olamiju@yale.edu   
Principal Investigator: Jonathan S. Leventhal, MD         
United States, Illinois
Northwestern University - Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Stephanie Rangel, PhD, CCRP       stephanie.rangel@northwestern.edu   
Principal Investigator: Jennifer N. Choi, MD         
United States, Kentucky
University of Louisville - Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mary Healey, CCRC       mary.healey@louisville.edu   
Principal Investigator: Robert C. Martin, MD,PhD,FACS         
United States, Maryland
VA Maryland Health Care System - NAVREF Recruiting
Baltimore, Maryland, United States, 21201
Contact: Dawn Hoelz       dawn.hoelz@va.gov   
Contact: Sandra Beam       sandra.beam@va.gov   
Principal Investigator: Thomas J. Hornyak, MD, PhD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sarah Garcia       sarah_garcia@dfci.harvard.edu   
Principal Investigator: Nicole R. LeBoeuf, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mary Tabacchi       mtabacchi@wustl.edu   
Principal Investigator: Milan J. Anadkat, MD         
United States, Nebraska
CHI Health St. Francis - Hospital Withdrawn
Hastings, Nebraska, United States, 68901
United States, Nevada
Innovative Clinical Research Institute Recruiting
Henderson, Nevada, United States, 89052
Contact: Kirsten Bettino, CCRP       kbettino@airesearch.us   
Principal Investigator: Gilbert M. Nyamuswa, MD         
United States, New York
Montefiore Einstein Center for Cancer Care Recruiting
Bronx, New York, United States, 10461
Contact: Alana Deutsch       alana.deutsch@einsteinmed.org   
Principal Investigator: Beth N. Mclellan, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10022
Contact: Sabrina Trelles       trelless@mskcc.org   
Principal Investigator: Mario E. Lacouture, MD         
United States, Ohio
Ohio State University Dermatology Recruiting
Columbus, Ohio, United States, 43215
Contact: Leah Kofmehl       Leah.Kofmehl@osumc.edu   
Principal Investigator: Benjamin H. Kaffenberger, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Christopher Chan       CChan2@mdanderson.org   
Principal Investigator: Anisha B. Patel, MD         
Sponsors and Collaborators
OnQuality Pharmaceuticals (USA) LLC
Investigators
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Principal Investigator: Mario E. Lacouture, MD Memorial Sloan Kettering Cancer Center
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Responsible Party: OnQuality Pharmaceuticals (USA) LLC
ClinicalTrials.gov Identifier: NCT04088318    
Other Study ID Numbers: OQL011B002
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No