A Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 9
- 主要终点
- Part 2:
研究概览
简要总结
A Phase II Study to Evaluate the Safety and Efficacy ofOQL011 on VEGFR inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
Primary Objective:
Part 2:
To evaluate the efficacy of OQL011 doses I-III compared to vehicle forthe treatment of HFSR as measured by the proportion of patients achieving IGA-HFSR grade 0 or 1 at Week 2.
Secondary Objective:
Part 2:
To evaluate the efficacy of OQL011 doses I-III compared to vehicle forthe treatment of HFSR as measured by the proportion of patients achievingIGA-HFSR grade 0 or 1 at Week 4.
To evaluate the efficacy of OQL011 doses I-III compared to vehicle forthe treatment of HFSR as measured by the proportion of patients achieving atleast 2 grade improvement in IGA-HFSR at Weeks 2 and 4.
To evaluate the efficacy of OQL011 doses I-III versus vehicle measuredby NCI CTCAE v5.0 for PPE, HF-QoL and daily pain score (NPRS) at Week 2 andWeek 4.
To compare the efficacy of OQL011 among doses I, II, and III, as well asto evaluate by dose level the exposure-response relationship of OQL011.
To evaluate the safety of OQL011 doses I-III versus vehicle in patientswith HFSR.
To evaluate PK of OQL011 doses I-III in patients with HFSR.
Toevaluate compliance in using VEGFRi between OQL011 doses I-III, or vehiclecontrol per patient diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The subjects will be included in the study based on the following criteria: 1) 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 anticancer 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 the 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 on the same dose.
- •Patient is able to use topical medications and complete questionnaires reliably.
- •ECOG performance score ≤ 2 7) Patient must have the ability to understand and the willingness to sign a written informed consent prior to study entry.
排除标准
- •The subjects will be excluded from the study based on the following criteria: 1) Patient with unresolved hand-foot skin disorders (CTCAE 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 ahead of randomization.
- •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.
- •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.
- •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 of 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/mm3 • Hemoglobin (Hgb) ≤8.0 g/dL • Platelet count ≤75,000/mm3 • 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 <2.8g/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 9) 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.
结局指标
主要结局
Part 2:
时间窗: Proportion of patients who have achieved IGA- HFSR grade 0 or 1 at Week 2.
To evaluate the efficacy of OQL011 doses I-III compared to vehicle for the treatment of HFSR as measured by the proportion of patients achieving IGA- HFSR grade 0 or 1 at Week 2.
时间窗: Proportion of patients who have achieved IGA- HFSR grade 0 or 1 at Week 2.
次要结局
- Part 2:(To evaluate the efficacy of OQL011 doses I-III compared to vehicle for the treatment of HFSR as measured by the proportion of patients achieving IGA-HFSR grade 0 or 1 at Week 4.)