Health Condition 1: L271- Localized skin eruption due to drugs and medicaments taken internally
Conditions
Interventions
Intervention1: Part-I:
Investigational Treatment: OQL011(Dose I) ointment
Part II:
Investigational Treatment: OQL011(Dose II and Dose III) ointment
: Part-I
Investigational Treatment: OQL011(Dose
Sponsors
ONQUALITY PHARMACEUTICALS USA LLC
Eligibility
Inclusion criteria
Inclusion criteria: The subjects will be included in the study based on the following criteria: 1) Patient must be age greater than or equal to 18 years. 2) Patient must have a confirmed cancer diagnosis for which VEGFRi treatment is indicated, and must be currently under VEGFRi-based anticancer therapy with stable dosage for greater than or equal to 1 week. This treatment may be VEGFRi monotherapy or VEGFRi-based combination therapy, so long as it does not include prohibited therapies. 3) Patient must have shown signs of HFSR that meet the NCI CTCAE v5.0 Term Palmar-plantar Erythrodysesthesia Syndrome criteria as grade 2 or higher. 4) 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. 5) Patient is able to use topical medications and complete questionnaires reliably. 6) ECOG performance score less than or equal to 2 7) Patient must have the ability to understand and the willingness to sign a written informed consent prior to study entry.
Exclusion criteria
Exclusion criteria: The subjects will be excluded from the study based on the following criteria: 1) Patient with unresolved hand or foot skin disorders (CTCAE grade 2 or higher) due to other medications within 4 weeks prior to study entry. 2) Patient who is using other topical medications in the hands or feet area and cannot stop such usage greater than7 days ahead of randomization. 3) Patient who is on concurrent cancer medications that can cause skin reactions in hands or feet, such as capecitabine, pegylated liposomal doxorubicin, 5-fluorouracil, dabrafenib, vemurafenib, doxorubicin, docetaxel, cytarabine, ramucirumab and bevacizumab. 4) 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 (including orthostatic hypotension) or hypertension, cardiac arrhythmia, or psychiatric illness and social situations that would limit compliance with study requirements. 5) Patient who has contraindication with the active compound, including severe anemia, increased intracranial pressure, known hypersensitivity. 6) 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, handperfoot eczema, palmoplantar pustulosis, palmoplantar keratosis, acrodermatitis continua etc. 7) Patient who used of phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil, vardenafil, and tadalafil within past 7 days. 8) Patient with significantly abnormal lab test: Inadequate hematologic function as indicated by: • Absolute neutrophil counts (ANC) less than or equal to1,000 per mm3 • Hemoglobin (Hgb) less than or equal to8.0 g per dL • Platelet count less than or equal to75, 000 per mm3 • PT or PTT greater than 1.5 x ULN (if patients on anticoagulants: PT INR greater than3.5 x ULN). Inadequate renal and liver function as indicated by: • Albumin less than 2.8g per dL • Total bilirubin greater than or equal to 1.5 x ULN (or greater than or equal to2.5 x ULN for patients with Gilbertâ??s syndrome) • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase greater than or equal to3 x ULN (or greater than or equal to5 x ULN for patients with liver cancer) • Creatinine greater than 2.0 x ULN 9) Pregnant or nursing women. 10) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: To evaluate the efficacy of OQL011 dose I versus vehicle measured by the proportion of patients achieving NCI CTCAE v5.0 for PPE grade 0 or 1 by Week 3. Part 2: To evaluate the efficacy of OQL011 dose II and dose III compared to vehicle for the treatment of HFSR as measured by the proportion of patients achieving NCI CTCAE v5.0 for PPE grade 0 or 1 by Week 3. Timepoint: Nine patients will go through a PK study. Blood samples will be taken on Day 0 at pre-dose and 5 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hour, 2 hour, 4 hour, 6 hour, 8 hour, after the first application of investigational drugs. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of OQL011 dose II and dose III versus vehicle measured by IGA-i, IGA-c, NCI CTCAE v5.0 for PPE, HF-QoL, daily pain score (VAS) by Week 3 and Week 6. To evaluate the safety of OQL011 dose II and dose III versus vehicle in patients with HFSR. To evaluate PK of OQL011 dose II and dose III in patients with HFSR Timepoint: Fifteen patients will go through a PK study. PK samples will be collected on Day 0 at pre-dose, 5 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hour, 2 hour, 4 hour, 6 hour, 8 hour, after the first application of investigational drugs. | — |
Countries
India, United States of America
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed