An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment
概览
- 阶段
- 4 期
- 干预措施
- Nilotinib
- 疾病 / 适应症
- Gastrointestinal Stromal Tumors
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Best Overall Response at month 6 determined according to the RECIST criteria based on local radiological assessments
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The purpose of this multicenter, single-arm, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
详细描述
The study planned a 6-month recruitment phase to enroll 40 subjects, followed by a 6-month treatment phase with monthly visits. Patients benefiting from the treatment could continue during a follow-up phase. On May 5, 2011, Novartis decided to discontinue the ongoing clinical trials with Nilotinib in GIST. This decision was influenced by the discontinuation of the ENESTg1 study (CAMN107G2301), which showed that Nilotinib was unlikely to demonstrate superiority to Imatinib in progression-free survival, the primary endpoint. The independent Data Management Committee (DMC) also reported no safety issues in either trial arm. Following the decision to close-out the Novartis- Sponsored studies CAMN107G2301 (NCT00785785) and CAMN107DDE05 (NCT01289028), the enrollment of the study CAMN107DDE06 was re-opened in order to ensure continued access to nilotinib to the patients currently in the CAMN107G2301 trial and CAMN107DDE05 trial in Germany and benefiting from the nilotinib treatment.
研究者
入排标准
入选标准
- •Age ≥18 years
- •Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent prior to or at Visit 1
- •At least one measurable site of disease on CT/MRI scan at Visit 1, as defined by RECIST criteria. The scans should be at maximum 2 weeks old. New scans are only required as baseline scans if they are older than approx. 2 weeks.
- •WHO Performance Status of 0, 1 or 2
- •Patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):
- •Potassium ≥ LLN,
- •Magnesium ≥ LLN,
- •Phosphorus ≥ LLN,
- •Total calcium (corrected for serum albumin) ≥ LLN
- •Patients must have normal organ, electrolyte, and marrow function as defined below:
排除标准
- •Prior treatment with nilotinib
- •Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1 with the exception of imatinib targeted therapy as an adjuvant therapy or imatinib in first line treatment for maximum of 4 weeks.
- •Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ
- •Impaired cardiac function at including any one of the following:
- •LVEF \< 45% or below the institutional LLN range (whichever is higher) as determined by echocardiogram at Visit 1
- •Complete left bundle branch block
- •Use of a ventricular paced cardiac pacemaker
- •Congenital long QT syndrome or family history of long QT syndrome
- •History of or presence of significant ventricular or atrial tachyarrhythmias
- •Clinically significant resting bradycardia (\< 50 beats per minute)
研究组 & 干预措施
nilotinib
nilotinib
干预措施: Nilotinib
结局指标
主要结局
Best Overall Response at month 6 determined according to the RECIST criteria based on local radiological assessments
时间窗: 6 months
Proportion of patients showing stable disease (SD), partial response (PR) or complete response (CR) during the first 6 months according to RECIST criteria
次要结局
- Time to Response (TTR)(6 months)
- Overall Survival (OS)(6 months)
- Objective Response Rate (ORR)(6 months)
- Duration of Response (DOR)(6 months)
- Progression-free Survival (PFS)(6 months)
- Incidence rate of adverse events (AEs)(6 months)