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

March 1, 2024 updated by: OnQuality Pharmaceuticals (USA) LLC

A Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226006
        • Nantong Tumor Hospital
      • Taizhou, Jiangsu, China, 225399
        • Taizhou People's Hospital
      • Wuxi, Jiangsu, China, 214028
        • Affiliated Hospital of Jiangnan University
      • Xuzhou, Jiangsu, China, 221004
        • The Affiliated Hospital of Xuzhou Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital Affiliated to Fudan University
      • Shanghai, Shanghai, China, 200233
        • Shanghai Sixth People's Hospital
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital
      • Shanghai, Shanghai, China, 200050
        • Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
  • India
    • Dimhans
      • Bīkaner, Dimhans, India
        • S.P Medical College & AG Hospitals, Bikaner
    • Gujarat
      • Sūrat, Gujarat, India, 395004
        • Kiran Multi Super Speciality Hospital & Research Center
      • Vadodara, Gujarat, India, 390002
        • Kailash Cancer Hospital and Research Center
    • Haryana
      • Hisar, Haryana, India, 125005
        • Aadhar Health Institute
      • Hisar, Haryana, India, 125005
        • Noble Hospital, Pune
    • Karnataka
      • Bangalore, Karnataka, India, 560072
        • Oncoville Cancer Hospital and Research Center
    • Maharashtra
      • Mumbai, Maharashtra, India, 400056
        • Mumbai Oncocare Centre
    • Nashik
      • Naka, Nashik, India, 422002
        • HCG Manavata Cancer centre, Nashik
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center
    • California
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University - Hospital
    • Florida
      • Miami, Florida, United States, 33165
        • AP Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University - Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville - Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Innovative Clinical Research Institute
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Einstein Center for Cancer Care
      • New York, New York, United States, 10022
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Centre
      • Columbus, Ohio, United States, 43215
        • Ohio State University Dermatology
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 (for Part 1) the NCI CTCAE v5.0 - PPE grade 2 or higher OR (for Part 2) IGA-HFSR criteria of grade 3 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OQL011 Dose I
OQL011, Dose I, ointment, to be applied topically, three times a day, for up to six weeks (in Part 1) or four weeks (in Part 2)
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 (in Part 1) or four weeks (in Part 2)
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 (in Part 1) or four weeks (in Part 2)
Drug: OQL011
OQL011 is an ointment containing active ingredient.
Other: Vehicle Ointment
Vehicle ointment, to be applied topically, three times a day, for up to six weeks (in Part 1) or four weeks (in Part 2)
Drug: Vehicle Ointment
Vehicle ointment is an ointment containing no active ingredient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
(For Part 1) Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0 or 1 OR (for Part 2) The proportion of patients achieving IGA-HFSR grade 0 or 1
Time Frame: 3 weeks (Part 1) OR 2 weeks (Part 2)
3 weeks (Part 1) OR 2 weeks (Part 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
(For Part 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.
3 weeks and 6 weeks
(For Part 2) Proportion of patients achieving IGA-HFSR grade 0 or 1
Time Frame: 4 weeks
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
4 weeks
(For Part 2) Proportion of patients achieving at least two-grade improvement in IGA-HFSR
Time Frame: 2 weeks and 4 weeks
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
2 weeks and 4 weeks
(For Part 1) Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0 or 1
Time Frame: 6 weeks
6 weeks
(For Part 2) Change from baseline in NCI CTCAE v5.0 - PPE grade
Time Frame: 2 weeks and 4 weeks
2 weeks and 4 weeks
Change from baseline in HF-QoL (Hand-Foot Skin Reaction and Quality of Life) Questionnaire total score
Time Frame: 3 weeks and 6 weeks (Part 1) OR 2 weeks and 4 weeks (Part 2)
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)
3 weeks and 6 weeks (Part 1) OR 2 weeks and 4 weeks (Part 2)
(For Part 1) 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.
3 weeks and 6 weeks
(For Part 2) Change from baseline in patient reported pain using NPRS (Numerical Pain Rating Scale)
Time Frame: 2 weeks and 4 weeks
The subject records pain associated with HFSR using score 0 to 10 ranging from "no pain" for Score 0 to "unbearable pain" for Score 10.
2 weeks and 4 weeks
(For Part 1) 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.
3 weeks and 6 weeks
Safety assessment by type, incidence and intensity of adverse events
Time Frame: 6 weeks (Part 1) and 4 weeks (Part 2)
6 weeks (Part 1) and 4 weeks (Part 2)
Plasma concentration of active compound and its derivatives
Time Frame: 1 day
1 day
(For Part 2) The exposure-response relationship of different dose level OQL011
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OnQuality Pharmaceuticals (USA) LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mario E. Lacouture, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OQL011B002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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