Multi-Center, Open-Label Phase 1B Study to Evaluate the Safety and Tolerability of HGS1036 in Combination With Paclitaxel and Carboplatin, Cisplatin and Etoposide, or Docetaxel in Subjects With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 54
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel.
详细描述
This study will consist of 3 regimens each containing 2 dose levels of HGS1036 and full dose chemotherapy. Patients will be treated in sequence with HGS1036 at planned dose levels of 10 mg/kg and 20 mg/kg. Patients who demonstrate stable disease or better may continue to receive HGS1036 until progressive disease, unacceptable toxicity, patient requests discontinuation of study treatment, or the Investigator feels further treatment is not in the patient's best interest. After discontinuation of HGS1036, subjects will be followed for 30 days after the last dose of HGS1036 for safety. The end of study will be defined as 1 year after the last subject begins treatment of HGS1036. Any subject still receiving HGS1036 at this pre-defined end of study, may continue to receive HGS1036, but the only study assessments required will be for safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Have a histological or cytological diagnosis of malignant solid neoplasm requiring systemic chemotherapy.
- •Age ≥18 years.
- •ECOG performance status 0-
- •Adequate organ function.
- •Adequate hematological function.
- •Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.
- •Consent to collection of previously obtained, archival biopsy or surgical specimens of the currently treated malignancy when available.
排除标准
- •Significant cardiac disease.
- •Eye trauma or disease.
- •Ocular surgery or blunt force trauma to the eye requiring treatment within 3 months prior to first dose of HGS
- •Presence or history of ≥ Grade 2 hemoptysis within 2 weeks of the first dose of HGS
- •Major surgery within 4 weeks of the first dose of HGS
- •Prior organ or allogeneic stem cell transplant.
- •Non-healing or chronic wounds.
- •Receipt of any anti-cancer therapy within 4 weeks prior to first dose of HGS
- •Receipt of any biological therapy (such as monoclonal antibodies) within 6 weeks of the first dose of HGS
- •Active CNS involvement by primary or metastatic tumor.
- •Documented active infection requiring the use of systemic antibiotics.
- •Pregnancy or lactation.
- •Known HIV-positive serology, AIDS, or an AIDS-related illness.
- •Conditions likely to increase the potential for abdominal perforation or fistula formation.
研究组 & 干预措施
Arm A
HGS1036 + Paclitaxel + Carboplatin
干预措施: HGS1036 + Paclitaxel + Carboplatin (Drug)
Arm B
HGS1036 + Cisplatin + Etoposide
干预措施: HGS1036 + Cisplatin + Etoposide (Drug)
Arm C
HGS1036 + Docetaxel
干预措施: HGS1036 + Docetaxel (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Up to 1 year or longer if indicated.
Number of participants with adverse events
时间窗: Up to 1 year or longer if indicated.
次要结局
未报告次要终点