A Phase 2a Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of treatment related local adverse events
研究概览
简要总结
Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool temperatures.
This study investigate the preventive effect of TAR-0520 gel on TIPN and on nail toxicity.
Breast cancer patients under taxanes therapy will apply TAR-0520 Gel to one hand and the homolateral foot including fingers and toes. Other hand and foot will be untreated and will serve as control.
Patients will be followed during the 12 cycles of taxane therapy. Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaires administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of taxane nail toxicity will include a clinical grading by a nurse and a patient questionnaire.
详细描述
This is a Phase 2a, open label, intra-individual study with approximately 30 patients included.
Principal objective of the study is to confirm the local and systemic safety of TAR-0520 Gel applied twice daily to one hand and one foot, in breast cancer patients treated with taxanes.
Secondary objectives of the study are:
- To explore the preventative effect of TAR-0520 Gel on taxane-induced TIPN,
- To explore the preventative effect of TAR-0520 Gel on taxane-induced onycholysis and other nail changes.
Each patient will receive the active drug candidate TAR-0520 gel for 3 days at each taxane cycle (usually 12 cycles with an infusion every week). During these 3 days, TAR-0520 gel will be applied to one hand and one foot, twice daily, starting the day of taxane infusion and continuing the next two days (thus covering the period when Paclitaxel will be circulating: elimination half-life of the drug is approximately 24 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, who is at least 18 years of age or older
- •Patients with clinical diagnosis of breast cancer
- •Patients planned to be treated with paclitaxel or docetaxel
- •Patients who can understand and sign the Informed Consent Form
- •Patients who can apply the study gel by himself /herself or has a giver that can apply the product.
- •Female patients of childbearing potential who agree to use a highly effective method of contraception throughout the study
排除标准
- •Patient already treated with taxanes or other chemotherapies known to induce neuropathies
- •Patient with previously diagnosed peripheral neuropathy
- •Patient with concomitant therapies known to induce neuropathies
- •Patient treated for neuropathic pain
- •Patient with comorbid factors known to induce neuropathies (such as Diabetes, Alcoholism, HIV, Peripheral vascular disease, Vitamin B deficiencies)
- •Patient currently receiving monoamine oxidase (MAO) inhibitors therapy or patients on antidepressants which affect noradrenergic transmission e.g. tricyclic antidepressants and mianserin (as mentioned in the current topical brimonidine labeling of approved products).
- •Patient who will not be able to follow the protocol for physical or psychological reasons
- •Patient with history of skin disorders, significant skin disease, irritated skin or open wounds within the same body areas planned for the IMP application.
- •Known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label)
- •Female who is pregnant or lactating
- •Female who intends to conceive a child during the clinical trial
研究组 & 干预措施
Intra-individual active comparator vs no intervention
Tar-0520 gel will be applied to one hand and to homolateral foot ,other hand and foot will be not treated and will serve as control
干预措施: Brimonidine gel (Drug)
Intra-individual active comparator vs no intervention
Tar-0520 gel will be applied to one hand and to homolateral foot ,other hand and foot will be not treated and will serve as control
干预措施: No intervantion (Other)
结局指标
主要结局
Number of treatment related local adverse events
时间窗: From Baseline up to the end of 12 taxane perfusions
Treatement related local adverse events inluding erythema, oedema, pruritus
次要结局
- CTCAE grade of peripheral neuropathy(From Baseline up to the end of 12 taxane perfusions)
- Instrumental objective measures of TIPN - heat thresold(At Baseline and after 6th and 12th taxane perfusion)
- Instrumental objective measures of TIPN - cold thresold(At Baseline and after 6th and 12th perfusions)
- Instrumental objective measures of TIPN - vibration treshold(At Baseline and after 6th and 12th perfusion)
- Instrumental objective meeasures of TIPN - electrochemical skin conductance (ESC)(At Baseline and after 6th and 12 perfusion)