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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000009256 |
Receipt No. | R000010868 |
Scientific Title | A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer. |
Date of disclosure of the study information | 2012/11/05 |
Last modified on | 2012/11/03 |
Basic information | ||
Public title | A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer. | |
Acronym | A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer. | |
Scientific Title | A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer. | |
Scientific Title:Acronym | A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer. | |
Region |
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Condition | |||
Condition | Chemo-naïve advanced ALK positive NSCLC | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | To assess the safety of cisplatin and pemetrexed and crizotinib in patients with advanced ALK positive NSCLC |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | Maximum Tolerated schedule of crizotinib with cisplatin and pemetrexed |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | cisplatin (75mg/m2) + pemetrexed (500mg/m2)
level 1: crizotinib 200mg twice daily day1-7 level 2: crizotinib 250mg twice daily day1-7 level 3: criztotinib 250mg twice daily day1-14 level 4: crizotinib 250mg twice daily day 1-21 level 5: crizotinib 250mg twice daily |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Histologically or cytologically confirned non-small-cell lung cancer (NSCLC)
2)Diagnosed EML4-ALK positive by Fish or PCR 3)With measurable lesion 4)Stage IIIB without any indications for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy who have no prior chemoterapy 5)20 years old or older 6)ECOG PS 0-1 or older 7)Adequate organ function 8)Life expectancy more than 3 months 9)Signed informed consent |
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Key exclusion criteria | 1)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
2) History of poorly controlled pleural effusion,pericardial effusion and ascites 3)Not appropriate to receive the folic acid and vitamin B12 formulation 4)SVC syndrome 5)Symptomatic brain metastases 6)History of active double cancer 7)Uncontrollable diabetes mellitus and hypertension 8)Diagnosed as liver cirrhosis by image findings or clinical laboratory 9)Suffers from an infectious disease to need antibiotic treatment 10)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc within 6 months) 11)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment 12)History of grave drug allergic reaction 13)Acute inflammatory disease 14)An agreement is not obtained for support therapy such as transfusion etc. 15)History of active psychological disease 16)Having the bleeding tendency which is clear in clinic 17)Taking continuous whole body administration (oral administration or intravenous administration) of steroid 18)Patients whose participation in the trial is judged to be inappropriate by the attending doctor |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National organization Kinki-chuo chest medical center | ||||||
Division name | medical oncology | ||||||
Zip code | |||||||
Address | 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN | ||||||
TEL | 072-252-3021 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | National organization Kinki-chuo chest medical center | ||||||
Division name | medical oncology | ||||||
Zip code | |||||||
Address | 1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN | ||||||
TEL | 072-252-3021 | ||||||
Homepage URL | |||||||
asami@kch.hosp.go.jp |
Sponsor | |
Institute | National organization Kinki-chuo chest medical center |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010868 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |