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OQL011 for Hand-Foot Syndrome (NOVA-II Trial)

Phase 2
Waitlist Available
Led By Mario E. Lacouture, MD
Research Sponsored by OnQuality Pharmaceuticals (USA) LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks and 6 weeks (part 1) or 2 weeks and 4 weeks (part 2)
Awards & highlights

NOVA-II Trial Summary

This trial is testing a new ointment to see if it's safe and effective for treating hand-foot skin reaction, a common side effect of cancer treatment.

Who is the study for?
This trial is for adults with cancer who are being treated with VEGFR inhibitors and have developed moderate to severe Hand-Foot Skin Reaction (HFSR). They should be able to perform daily activities (ECOG ≤ 2), use topical medications, and complete questionnaires. Pregnant women, those on certain other cancer drugs or skin treatments, or with uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The study tests OQL011 ointment's safety and effectiveness against a non-medicated ointment in treating HFSR caused by cancer treatment drugs. It aims to find the best dose for future studies and understand how the body processes OQL011.See study design
What are the potential side effects?
While specific side effects of OQL011 aren't listed here, common side effects from topical medications may include skin irritation, redness, itching or rash at the application site.

NOVA-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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I can perform all self-care but may not be able to work.
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I have experienced severe skin reactions on my hands or feet.
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I have experienced severe skin reactions on my hands or feet.

NOVA-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks and 6 weeks (part 1) or 2 weeks and 4 weeks (part 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks and 6 weeks (part 1) or 2 weeks and 4 weeks (part 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(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
Secondary outcome measures
(For Part 1) Change from baseline in patient reported pain using VAS (Visual Analog Scale)
(For Part 1) Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0 or 1
(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
+9 more

NOVA-II Trial Design

4Treatment groups
Experimental Treatment
Group I: Vehicle OintmentExperimental Treatment1 Intervention
Vehicle ointment, to be applied topically, three times a day, for up to six weeks (in Part 1) or four weeks (in Part 2)
Group II: OQL011 Dose IIIExperimental Treatment1 Intervention
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)
Group III: OQL011 Dose IIExperimental Treatment1 Intervention
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)
Group IV: OQL011 Dose IExperimental Treatment1 Intervention
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)

Find a Location

Who is running the clinical trial?

OnQuality Pharmaceuticals (USA) LLCLead Sponsor
Mario E. Lacouture, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

OQL011 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04088318 — Phase 2
Hand-Foot Syndrome Research Study Groups: OQL011 Dose I, OQL011 Dose III, OQL011 Dose II, Vehicle Ointment
Hand-Foot Syndrome Clinical Trial 2023: OQL011 Highlights & Side Effects. Trial Name: NCT04088318 — Phase 2
OQL011 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04088318 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for participants to join this research endeavor?

"Affirmative. The information present on clinicaltrials.gov confirms that the trial is actively recruiting participants; it was first posted in December 2019 and last updated in November 2022, with 170 patients needed from 9 different sites."

Answered by AI

How many participants are actively engaging in this research trial?

"A total of 170 participants meeting the criteria must be enrolled in order to initiate this research. The sponsor, OnQuality Pharmaceuticals (USA) LLC, is recruiting from multiple locations including Northwestern University - Hospital in Chicago and VA Maryland Health Care System – NAVREF in Baltimore."

Answered by AI

How many physical sites are utilized in the implementation of this trial?

"Northwestern University - Hospital in Chicago, Illinois, VA Maryland Health Care System - NAVREF in Baltimore, Maryland and Ohio State University Dermatology in Columbus, Ohio are the main medical centres currently accepting patients for this research trial. Additionally, other locations across the US have opened enrolment as well."

Answered by AI

What measures are taken to ensure OQL011 is safe for human consumption?

"As this is still an early-stage trial, with evidence confirming the safety of OQL011 but none affirming efficacy, our team at Power felt it appropriate to give a score of 2."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
2019. "A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04088318.
~32 spots leftby Apr 2025
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