Hand-Foot Skin Reaction (HFSR)Phase 2NOVA-IINCT04088318

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

A Phase 2 study testing OQL011 in people with Hand-Foot Skin Reaction (HFSR), run by OnQuality Pharmaceuticals (USA) LLC at 33 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hand-Foot Skin Reaction (HFSR)
What is being tested?: OQL011
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 33 sitesin 3 countries
Study dates: 9 Dec 2019to Jun 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

33 sites in 3 countries.

Country

City, postcode or hospital

33 sites in 3 countries

United States15 sites

University of Colorado Cancer Center
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Gabrail Cancer Centre
Canton, Ohio, 44718
Northwestern University - Hospital
Chicago, Illinois, 60611
Ohio State University Dermatology
Columbus, Ohio, 43215
Western Regional Medical Center
Goodyear, Arizona, 85338
Innovative Clinical Research Institute
Henderson, Nevada, 89052
MD Anderson Cancer Center
Houston, Texas, 77030
University of Louisville - Hospital
Louisville, Kentucky, 40202
AP Medical Research
Miami, Florida, 33165
Yale University - Hospital
New Haven, Connecticut, 06519
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461
Innovative Clinical Research Institute
Whittier, California, 90603

Other trials in United States

China10 sites

Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Nantong Tumor Hospital
Nantong, Jiangsu, 226006
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200050
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Taizhou People's Hospital
Taizhou, Jiangsu, 225399
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214028
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004

Other trials in China

India8 sites

Oncoville Cancer Hospital and Research Center
Bangalore, Karnataka, 560072
S.P Medical College & AG Hospitals, Bikaner
Bīkaner, Dimhans
Aadhar Health Institute
Hisar, Haryana, 125005
Noble Hospital, Pune
Hisar, Haryana, 125005
Mumbai Oncocare Centre
Mumbai, Maharashtra, 400056
HCG Manavata Cancer centre, Nashik
Nāka, Nashik, 422002
Kiran Multi Super Speciality Hospital & Research Center
Surat, Gujarat, 395004
Kailash Cancer Hospital and Research Center
Vadodara, Gujarat, 390002

Other trials in India

About this study

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

Conditions: Hand-Foot Skin Reaction (HFSR)
Being tested: OQL011, Vehicle Ointment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OQL011Drug
OQL011 is an ointment containing active ingredient.
Vehicle OintmentDrug
Vehicle ointment is an ointment containing no active ingredient.

Study groups in NCT04088318
Study group	Role	What they receive
OQL011 Dose I	Experimental	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) Receives: Drug: OQL011
OQL011 Dose II	Experimental	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) Receives: Drug: OQL011
OQL011 Dose III	Experimental	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) Receives: Drug: OQL011
Vehicle Ointment	Other	Vehicle ointment, to be applied topically, three times a day, for up to six weeks (in Part 1) or four weeks (in Part 2) Receives: Drug: Vehicle Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

(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
Measured: 3 weeks (Part 1) OR 2 weeks (Part 2)

Secondary outcomes (12)

(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
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Measured: 3 weeks and 6 weeks
(For Part 2) Proportion of patients achieving IGA-HFSR grade 0 or 1
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Measured: 4 weeks
(For Part 2) Proportion of patients achieving at least two-grade improvement in IGA-HFSR
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Measured: 2 weeks and 4 weeks
(For Part 1) Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0 or 1
Measured: 6 weeks
(For Part 2) Change from baseline in NCI CTCAE v5.0 - PPE grade
Measured: 2 weeks and 4 weeks
Change from baseline in HF-QoL (Hand-Foot Skin Reaction and Quality of Life) Questionnaire total score
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)
Measured: 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)
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.
Measured: 3 weeks and 6 weeks
(For Part 2) Change from baseline in patient reported pain using NPRS (Numerical Pain Rating Scale)
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.
Measured: 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
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Measured: 3 weeks and 6 weeks
Safety assessment by type, incidence and intensity of adverse events
Measured: 6 weeks (Part 1) and 4 weeks (Part 2)
Plasma concentration of active compound and its derivatives
Measured: 1 day
(For Part 2) The exposure-response relationship of different dose level OQL011
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 2019Jun 2024

First posted12 Sep 2019
Study start9 Dec 2019
Primary completion26 Feb 2024
Study completionJun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hand-Foot Skin Reaction (HFSR)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 170 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04088318
Sponsor's protocol ID: OQL011B002
Acronym: NOVA-II
Status last verified: Sep 2023
First submitted: 30 Aug 2019
Last updated: 4 Mar 2024
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: There is no plan to make individual participant data (IPD) available to other researchers.

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04088318
Acronym / sponsor ID: NOVA-II / OQL011B002
Conditions: Hand-Foot Skin Reaction (HFSR)
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 170 participants (estimated)
Lead sponsor: OnQuality Pharmaceuticals (USA) LLCIndustry (pharma, biotech, devices)
Study start: 9 Dec 2019 (actual)
Primary completion: 26 Feb 2024 (actual)
Study completion: Jun 2024 (estimated)
First posted: 12 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
OQL011 Dose I	Experimental	Drug: OQL011OQL011, 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)
OQL011 Dose II	Experimental	Drug: OQL011OQL011, 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)
OQL011 Dose III	Experimental	Drug: OQL011OQL011, 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)
Vehicle Ointment	Other	Drug: Vehicle OintmentVehicle ointment, to be applied topically, three times a day, for up to six weeks (in Part 1) or four weeks (in Part 2)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OQL011OQL011 is an ointment containing active ingredient.	Drug	OQL011 Dose I, OQL011 Dose II, OQL011 Dose III
Vehicle OintmentVehicle ointment is an ointment containing no active ingredient.	Drug	Vehicle Ointment

Primary outcome

(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)

12 secondary outcomes

(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
(For Part 2) Proportion of patients achieving IGA-HFSR grade 0 or 1
Time frame: 4 weeks
(For Part 2) Proportion of patients achieving at least two-grade improvement in IGA-HFSR
Time frame: 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
(For Part 2) Change from baseline in NCI CTCAE v5.0 - PPE grade
Time frame: 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)
(For Part 1) Change from baseline in patient reported pain using VAS (Visual Analog Scale)
Time frame: 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
(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
Safety assessment by type, incidence and intensity of adverse events
Time frame: 6 weeks (Part 1) and 4 weeks (Part 2)
Plasma concentration of active compound and its derivatives
Time frame: 1 day
(For Part 2) The exposure-response relationship of different dose level OQL011
Time frame: 4 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mario E. Lacouture, MD principal investigator

Memorial Sloan Kettering Cancer Center

33 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OQL011 in people with Hand-Foot Skin Reaction (HFSR), run by OnQuality Pharmaceuticals (USA) LLC at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, China, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04088318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.