A Phase II, Open-label Single-Arm Study to Evaluate the efficacy and Safety of Vandetanib in Patients with RET Fusion-positive Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- nresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer with RET Fusion-positive
- Registration Number
- JPRN-UMIN000010095
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 17
Not provided
1.The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 4 weeks before the start of study therapy 2.The last radiation therapy within 4 weeks before the start of study therapy 3.Major surgery within 4 weeks before the start of study therapy, or incompletely healed surgical incision 4.Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy 5.Significant cardiac event, superior vena cava syndrome, New York Heart Association classification of heart disease ≥2, within 12 weeks before registration 6.History of arrhythmia, which is symptomatic or requires treatment (CTCAE grade 3) 7.Congenital long QTc syndrome 8.QTc prolongation with other medications that required discontinuation of that medication 9.Potassium concentration <4.0 mEq/L, calcium or magnesium concentrations outside of normal limits at each site despite supplementation 10.Currently pregnant or breast feeding 11.Any concomitant medications that have been associated with Torsades de Pointes or strong inducers of CYP3A4 function within 2 weeks of start of study treatment. 12.Unstable brain metastases or spinal cord compression that requires treatment 13.Hypertension not controlled by medical therapy 14.Previous or current malignancies of other histologies within the last 5 years 15.Evidence of severe or uncontrolled systemic disease 16. Any evidence of clinically active interstitial lung disease 17.Previous exposure to vandetanib
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome variable-ORR
- Secondary Outcome Measures
Name Time Method Adverse events PFS DCR Duration of response OS The efficacy of cytotoxic chemotherapy for RET fusion-positive NSCLC will be reported using the previous or post treatment data