Trials Sponsors Conditions Drugs Pricing

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
+7 more secondary outcomes

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)

Interventions

OQL011Drug

OQL011 is an ointment containing active ingredient.

OQL011 Dose IOQL011 Dose IIOQL011 Dose III

Vehicle OintmentDrug

Vehicle ointment is an ointment containing no active ingredient.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

OnQuality Pharmaceuticals (USA) LLC
Industrylead

Study Sites (33)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Innovative Clinical Research Institute

Whittier, California, 90603, United States

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Yale University - Hospital

New Haven, Connecticut, 06519, United States

AP Medical Research

Miami, Florida, 33165, United States

Northwestern University - Hospital

Chicago, Illinois, 60611, United States

University of Louisville - Hospital

Louisville, Kentucky, 40202, United States

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

Actual (reported)

Primary Completion

February 26, 2024

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (4)

OQL011 Dose I

OQL011 Dose II

OQL011 Dose III

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

Study Officials

Study Design

Study Record Dates

Vehicle Ointment

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (4)

OQL011 Dose I

OQL011 Dose II

OQL011 Dose III

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

Study Officials

Study Design

Study Record Dates

Vehicle Ointment

You may not qualify if:

Data Sharing

Source record

Locations