ID
42252
Beskrivning
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer
Nyckelord
Versioner (1)
- 2021-04-20 2021-04-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 april 2021
DOI
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Licens
Creative Commons BY 4.0
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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)
Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
1. Written informed consent.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
2. Age at least 18 years old.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0149925
- UMLS CUI [1,2]
- C0231449
Beskrivning
4. Patient has had no prior chemotherapy or immunotherapy.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C0021083
Beskrivning
Measurable disease on CT or MRI scan must have one diameter >= 1 cm and one diameter >= 2 cm Measurable disease on chest X-ray must have both diameters >=2 cm. Palpable tumor masses that cannot be evaluated radiologically must have two diameters >= 2 cm. A measurable skin lesion must have at least one diameter >= 1 cm and it's presence must be evaluated by a photograph.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1513040
- UMLS CUI [1,3]
- C1705052
- UMLS CUI [2,1]
- C0221198
- UMLS CUI [2,2]
- C1522602
- UMLS CUI [3]
- C0040405
- UMLS CUI [4]
- C0024485
- UMLS CUI [5]
- C0031809
Beskrivning
6. It has been at least 3 weeks since any previous surgery (a lesser period is acceptable if deemed in the best interest of the patient).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205156
Beskrivning
Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects. Permanent and stable side effects or changes are acceptable.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3898008
- UMLS CUI [2]
- C1522449
- UMLS CUI [3]
- C0280962
Beskrivning
- haemoglobin >= 9.0 g/dL (after transfusion if needed) - WBC >= 3.5 x 10^9/L - neutrophils >= 1.5 x 10^9/L - platelets >= 100 x 10^9/L - creatinine <=1.5 mg/dL (133 micromol/L) - creatinine clearance >= 60 mL/min calculated using the Cockcroft Gault formula - serum bilirubin <= 2.0 mg/dL (34 micromol/L) - SGOT/AST, SGPT/ALT, and Alkaline Phosphatase <= 2 times the upper limit of normal if liver metastases cannot be visualised by abdominal CT or MRI scan; or <= 5 times the upper limit of normal if liver metastases are present.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C0031843
- UMLS CUI [2]
- C0232804
- UMLS CUI [3]
- C0232741
Beskrivning
9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1520224
Beskrivning
10. Patient has a predicted life expectancy of at least 3 months at screening.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023671
- UMLS CUI [2]
- C0220908
Beskrivning
11. Patient is not of reproductive potential, or if the patient is of reproductive potential the patient agrees to practice an effective method of contraception.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015895
- UMLS CUI [2]
- C0700589
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
1. Patient is female and is pregnant or lactating.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Beskrivning
2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Beskrivning
3. Patient has an uncontrolled infection.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205318
Beskrivning
4. Patient has previous or concomitant malignancies at other sites within the last 5 years excepting basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix or stage A low grade prostate cancer.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0006826
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0007117
- UMLS CUI [4]
- C0007137
- UMLS CUI [5]
- C0851140
- UMLS CUI [6]
- C0280280
Beskrivning
5. Patient has only undimensionally measurable or evaluable disease.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1513041
- UMLS CUI [2]
- C1516986
Beskrivning
A patient with brain and/ or leptomeningeal metastases on CT or MRI scan may be included only if he/ she is asymptomatic on neurological exam and is not receiving corticosteroid therapy to control symptoms)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0037088
- UMLS CUI [2]
- C0220650
- UMLS CUI [3]
- C1704231
- UMLS CUI [4]
- C0040405
- UMLS CUI [5]
- C0024485
Beskrivning
7. Patient has concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205082
- UMLS CUI [2,1]
- C0006826
- UMLS CUI [2,2]
- C0439849
- UMLS CUI [3]
- C1321605
- UMLS CUI [4,1]
- C0205403
- UMLS CUI [4,2]
- C0035647
- UMLS CUI [5,1]
- C0023671
- UMLS CUI [5,2]
- C0547047
Beskrivning
8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0304229
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0332152
Beskrivning
Radiotherapy may be given concomitantly for the palliative control of bone pain, however not all measurable or evaluable lesions should be included in the irradiated field.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3665472
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0021083
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0149925
Beskrivning
10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018799
- UMLS CUI [1,2]
- C2347662
- UMLS CUI [2]
- C0018802
- UMLS CUI [3,1]
- C0003811
- UMLS CUI [3,2]
- C0087111
- UMLS CUI [4]
- C0027051
Beskrivning
11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0013227
- UMLS CUI [3]
- C1301624
Beskrivning
Inclusion/ Exclusion
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0231449 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
C1513040 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1522602 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0205156 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0280962 (UMLS CUI [3])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0220908 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C0205318 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3])
C0007137 (UMLS CUI [4])
C0851140 (UMLS CUI [5])
C0280280 (UMLS CUI [6])
C1516986 (UMLS CUI [2])
C0220650 (UMLS CUI [2])
C1704231 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3])
C0205403 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0023671 (UMLS CUI [5,1])
C0547047 (UMLS CUI [5,2])
C0008976 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0149925 (UMLS CUI [3])
C2347662 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0205394 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3])
C0680251 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])