ID
44275
Beskrivning
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma
Nyckelord
Versioner (2)
- 2019-02-24 2019-02-24 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 september 2021
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556
Screening - Demography; Inclusion Criteria; Exclusion Criteria
- StudyEvent: ODM
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date informed consent signed
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Beskrivning
Subject Initials
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
If other race, please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0021430
Beskrivning
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0026764
- UMLS CUI [2]
- C0162643
Beskrivning
3. The subject has measurable disease.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1513041
Beskrivning
4. The subject has relapsed or relapsed/refractory disease
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0205269
Beskrivning
5. The subject has a life expectancy of greater than 6 months.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023671
Beskrivning
6. The subject has an ECOG Performance status of 0 to 2.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1520224
Beskrivning
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Beskrivning
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C2826293
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C0205161
- UMLS CUI [2,3]
- C2826293
Beskrivning
9. The subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0565998
- UMLS CUI [2,1]
- C2700391
- UMLS CUI [2,2]
- C1507394
Beskrivning
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1321605
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C1512346
- UMLS CUI [1,5]
- C0086960
- UMLS CUI [1,6]
- C1709747
Beskrivning
11. The subject must understand and voluntarily sign an informed consent document.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
12. If the subject is of reproductive potential, the subject must agree prior to study entry to use ad equate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4034483
- UMLS CUI [1,2]
- C0700589
Beskrivning
13. The subject must have Adequate end organ function
Datatyp
integer
Alias
- UMLS CUI [1]
- C0678852
- UMLS CUI [2]
- C0201913
- UMLS CUI [3]
- C0201836
- UMLS CUI [4]
- C0201899
- UMLS CUI [5]
- C0201976
- UMLS CUI [6]
- C0948762
- UMLS CUI [7]
- C0005821
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
1. Intolerance to resveratrol, SRT501, bortezomib, Boron, Mannitol or prior toxicity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0073096
- UMLS CUI [2,1]
- C1744706
- UMLS CUI [2,2]
- C2002402
- UMLS CUI [3,1]
- C1744706
- UMLS CUI [3,2]
- C1176309
- UMLS CUI [4,1]
- C1744706
- UMLS CUI [4,2]
- C0006030
- UMLS CUI [5,1]
- C1744706
- UMLS CUI [5,2]
- C0024730
- UMLS CUI [6]
- C0013221
Beskrivning
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0007117
- UMLS CUI [1,4]
- C0553723
Beskrivning
3. The subject has an uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205318
- UMLS CUI [2]
- C0009450
- UMLS CUI [3]
- C0018802
- UMLS CUI [4]
- C0002965
- UMLS CUI [5]
- C0003811
- UMLS CUI [6]
- C1735346
- UMLS CUI [7]
- C0265122
- UMLS CUI [8]
- C0004936
Beskrivning
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0017178
- UMLS CUI [1,2]
- C4054723
- UMLS CUI [1,3]
- C0678745
Beskrivning
5. Breast Feeding | Pregnancy | Sex Behavior | Contraceptive methods; Appropriate | Serum pregnancy test negative; Serum Beta-HCG Test | Postmenopausal state | Female Sterilization
Datatyp
integer
Alias
- UMLS CUI [1]
- C0006147
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0036864
- UMLS CUI [4,1]
- C0700589
- UMLS CUI [4,2]
- C1548787
- UMLS CUI [5,1]
- C0430061
- UMLS CUI [5,2]
- C1255526
- UMLS CUI [6]
- C0232970
- UMLS CUI [7]
- C0015787
Beskrivning
6. The subject has had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C1522449
- UMLS CUI [3]
- C0021430
- UMLS CUI [4]
- C0877248
Beskrivning
7. The subject is on concurrent medications that may exhibit anti-neoplastic therapy, with the exception of ≤10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C2827774
- UMLS CUI [2]
- C0032952
- UMLS CUI [3]
- C0020268
- UMLS CUI [4]
- C0456388
Beskrivning
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0242295
- UMLS CUI [2]
- C0949266
- UMLS CUI [3]
- C0073096
Beskrivning
9. The subject has peripheral neuropathy of Grade 2 or greater.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031117
Beskrivning
10. The subject has uncontrolled bleeding.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0019080
Beskrivning
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory.
Datatyp
integer
Alias
- UMLS CUI [1]
- C2748540
- UMLS CUI [2]
- C1390214
- UMLS CUI [3]
- C0005821
Beskrivning
12. The subject has a hemoglobin level less than < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0019046
- UMLS CUI [2]
- C1879316
- UMLS CUI [3]
- C0014822
Beskrivning
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1853129
Similar models
Screening - Demography; Inclusion Criteria; Exclusion Criteria
- StudyEvent: ODM
C0009797 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0162643 (UMLS CUI [2])
C0205269 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0205307 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
C2700391 (UMLS CUI [2,1])
C1507394 (UMLS CUI [2,2])
C1321605 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1512346 (UMLS CUI [1,4])
C0086960 (UMLS CUI [1,5])
C1709747 (UMLS CUI [1,6])
C0700589 (UMLS CUI [1,2])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0005821 (UMLS CUI [7])
C0073096 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2002402 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1176309 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0006030 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0024730 (UMLS CUI [5,2])
C0013221 (UMLS CUI [6])
C1705847 (UMLS CUI [1,2])
C0007117 (UMLS CUI [1,3])
C0553723 (UMLS CUI [1,4])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C1735346 (UMLS CUI [6])
C0265122 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C4054723 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0036864 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C0430061 (UMLS CUI [5,1])
C1255526 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6])
C0015787 (UMLS CUI [7])
C1522449 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0877248 (UMLS CUI [4])
C2827774 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2])
C0020268 (UMLS CUI [3])
C0456388 (UMLS CUI [4])
C0949266 (UMLS CUI [2])
C0073096 (UMLS CUI [3])
C1390214 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C1879316 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
C1853129 (UMLS CUI [2])