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

NCT04088318 | Unknown Phase 2 FDA Drug

• 1 other identifier: OQL011B002
• Study Type: interventional
• Target: 170
• Locations: 3 countries
• Sites: 33

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.

Conditions

Hand-Foot Skin Reaction (HFSR)

Outcome Measures

Primary Outcomes (1)

• (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

  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

  3 weeks and 6 weeks

• (For Part 2) Proportion of patients achieving IGA-HFSR grade 0 or 1

  4 weeks

• (For Part 2) Proportion of patients achieving at least two-grade improvement in IGA-HFSR

  2 weeks and 4 weeks

• (For Part 1) Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0 or 1

  6 weeks

• (For Part 2) Change from baseline in NCI CTCAE v5.0 - PPE grade

  2 weeks and 4 weeks

Study Arms (4)

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)

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)

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)

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)

Drug: Vehicle Ointment

Interventions

OQL011 DRUG

OQL011 is an ointment containing active ingredient.

OQL011 Dose I; OQL011 Dose II; OQL011 Dose III

Vehicle Ointment DRUG

Vehicle ointment is an ointment containing no active ingredient.

Vehicle Ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• OnQuality Pharmaceuticals (USA) LLC: lead

Study Sites (33)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Yale University - Hospital

New Haven, Connecticut, 06519, United States

Location

AP Medical Research

Miami, Florida, 33165, United States

Location

Northwestern University - Hospital

Chicago, Illinois, 60611, United States

Location

University of Louisville - Hospital

Louisville, Kentucky, 40202, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Innovative Clinical Research Institute

Henderson, Nevada, 89052, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10022, United States

Location

Montefiore Einstein Center for Cancer Care

The Bronx, New York, 10461, United States

Location

Gabrail Cancer Centre

Canton, Ohio, 44718, United States

Location

Ohio State University Dermatology

Columbus, Ohio, 43215, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Nantong Tumor Hospital

Nantong, Jiangsu, 226006, China

Location

Taizhou People's Hospital

Taizhou, Jiangsu, 225399, China

Location

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214028, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200050, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

S.P Medical College & AG Hospitals, Bikaner

Bīkaner, Dimhans, India

Location

Kiran Multi Super Speciality Hospital & Research Center

Surat, Gujarat, 395004, India

Location

Kailash Cancer Hospital and Research Center

Vadodara, Gujarat, 390002, India

Location

Aadhar Health Institute

Hisar, Haryana, 125005, India

Location

Noble Hospital, Pune

Hisar, Haryana, 125005, India

Location

Oncoville Cancer Hospital and Research Center

Bangalore, Karnataka, 560072, India

Location

Mumbai Oncocare Centre

Mumbai, Maharashtra, 400056, India

Location

HCG Manavata Cancer centre, Nashik

Nāka, Nashik, 422002, India

Location

Study Officials

• Mario E. Lacouture, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 12, 2019
• Study Start: December 9, 2019
• Primary Completion: February 26, 2024
• Study Completion: June 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10); US (15); IN (8)