Status:
COMPLETED
Dovitinib Plus Docetaxel in Gastric Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
PHASE2
Brief Summary
Docetaxel is currently one of standard second-line therapy in patients with gastric cancer. As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer, dovitinib, dual VE...
Eligibility Criteria
Inclusion
- Pathologically proven metastatic or unresectable adenocarcinoma of stomach or gastroesophageal junction
- Patients with progressive disease (radiological confirmation required) after one line of chemotherapy except taxane for advanced gastric cancer in palliative setting
- Presence of at least one evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Age of 18 to 74 years
- Estimated life expectancy of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0\~2
- Adequate bone marrow function (Absolute neutrophil counts ≥ 1,500/uL, hemoglobin ≥ 8.0g/dL, and platelet ≥ 100,000/uL)
- Adequate renal function (creatinine \< 1.5mg/dL)
- Adequate hepatic function (total bilirubin \< 1.5 mg/dL, transaminase \< 3 times the upper normal limit \[5 times for patients with liver metastasis\])
- No prior anti-angiogenic therapy (anti-VEGF or VEGFR tyrosine kinase inhibitor etc) or FGF/FGFR inhibitor
- No prior radiation therapy within 4 weeks of the study (Irradiated lesions should not be included in the evaluable lesions.)
- Written informed consent
Exclusion
- Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
- Bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Presence of central nervous system (CNS) metastasis
- History of significant neurologic or psychiatric disorders
- Significant cardiac disease within 6 months of the study (congestive heart failure uncontrollable by medication, symptomatic coronary heart disease, or arrhythmia, myocardial infarction)
- Left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA), \< 45%
- Uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to study entry.
- QTc \> 480 msec on screening ECG
- Proteinuria defined by NCI CTCAE grade \> 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection ( \> 1g/24hrs). Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
- History of thrombotic or bleeding diathesis or coagulopathy
- Serious non-healing wound, peptic ulcer, or bone fracture
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01921673
Start Date
August 1 2013
End Date
October 1 2016
Last Update
July 14 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736