Unique ID issued by UMIN | UMIN000010095 |
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Receipt number | R000011780 |
Scientific Title | 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 |
Date of disclosure of the study information | 2013/02/22 |
Last modified on | 2016/12/14 09:53:13 |
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
LURET
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
LURET
Japan |
Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer with RET Fusion-positive
Pneumology | Hematology and clinical oncology |
Malignancy
NO
The primary objective of this study is to evaluate the objective response rate (ORR) in patients with RET fusion-positive unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) treated at vandetanib.
Others
1. To evaluate progression-free survival (PFS) in patients treated at vandetanib.
2. To evaluate disease control rate (CR+PR+SD [>8 weeks]) in patients treated at vandetanib.
3. To assess the duration of response in patients treated at vandetanib.
4. .To evaluate overall survival (OS) in patients treated at vandetanib.
5. To evaluate the safety and tolerability in patients treated at vandetanib.
6. To explore the efficacy of cytotoxic chemotherapy for RET fusion-positive NSCLC using the previous or post treatment data.
Exploratory
Phase II
Primary outcome variable-ORR
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Vandetanib at 300 mg using 3 x vandetanib tablets 100 mg will be dosed orally, once daily.
20 | years-old | <= |
Not applicable |
Male and Female
1. Written informed consent
2. Female or male aged 20 years and over
3. Histologically or cytologically confirmation of non-squamous NSCLC
4. Unresectable locally advanced or metastatic disease
5. Positive for RET fusion determined by tumor sample
6. EGFR mutation negative
7. ALK fusion negative
8. Progressive of NSCLC after at least one prior chemotherapy regimen
9. Life expectancy of 3 months or longer
10. ECOG Performance status 0-2
11. Negative pregnancy test for female patients of childbearing potential
12. One or more measurable disease by RECIST
13. Adequate bone marrow function
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
17
1st name | |
Middle name | |
Last name | Koichi Goto |
National Cancer Center Hospital East
Division of Thoracic Oncology
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
04-7133-1111
ret_core@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Kiyotaka Yoh |
National Cancer Center Hospital East
Division of Thoracic Oncology
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
04-7133-1111
ret_core@east.ncc.go.jp
National Cancer Center Hospital East
Ministry of Health, Labour and Welfare/Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
AstraZeneca/Sanofi
NO
国立がん研究センター東病院(千葉県)
2013 | Year | 02 | Month | 22 | Day |
Partially published
http://www.sciencedirect.com/science/article/pii/S2213260016303228
Main results already published
2012 | Year | 12 | Month | 10 | Day |
2013 | Year | 02 | Month | 18 | Day |
2013 | Year | 02 | Month | 22 | Day |
2016 | Year | 12 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011780
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