Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
研究概览
简要总结
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.
详细描述
This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.
Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.
Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.
Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:
Regimen A
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females at least 18 years of age with ovarian carcinoma who are one of the following:
- •Newly diagnosed with ovarian cancer and chemotherapy naïve, or
- •Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or
- •Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit.
- •Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests
- •Adequate blood coagulation parameters as measured by standard blood tests for coagulation
排除标准
- •Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria
- •Significant unstable cardiovascular disease
- •Uncontrolled high blood pressure
- •Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists
- •Evidence of metastatic disease to the bone
- •Metastatic disease to the CNS requiring treatment or radiation therapy
- •Uncontrolled infection(s)
- •Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years
- •Concurrent use of hematopoietic or erythropoietic agents
研究组 & 干预措施
TXA127 100 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
干预措施: TXA127 (Drug)
TXA127 300 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
干预措施: TXA127 (Drug)
Placebo
Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
时间窗: During a maximum of six 3-week chemotherapy cycles
Mean percentage of cycles with platelet counts below 50,000/mm3
次要结局
- Subjects With Platelet Counts Below 50,000/mm3(During a maximum of six 3-week chemotherapy cycles)
- Treatment Cycles With Platelets Counts Below 25,000/mm3(During a maximum of six 3-week chemotherapy cycles)
- Chemotherapy Dose Intensity and Dose Density(During a maximum of six 3-week chemotherapy cycles)
- Lymphopenia as Determined by Lymphocyte Count(During a maximum of six 3-week chemotherapy cycles)
- Neutropenia(During a maximum of six 3-week chemotherapy cycles)
- Anemia(During a maximum of six 3-week chemotherapy cycles)
- Mucositis(During a maximum of six 3-week chemotherapy cycles)
- Alopecia(During a maximum of six 3-week chemotherapy cycles)
- Rescue Treatment for Hematopoiesis and Mucositis(During a maximum of six 3-week chemotherapy cycles)