ID
35202
Beschreibung
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
Stichworte
Versionen (2)
- 24.02.19 24.02.19 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. Februar 2019
DOI
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Lizenz
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
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date informed consent signed
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Beschreibung
Subject Initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
If other race, please specify.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0021430
Beschreibung
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0026764
- UMLS CUI [2]
- C0162643
Beschreibung
3. The subject has measurable disease.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1513041
Beschreibung
4. The subject has relapsed or relapsed/refractory disease
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0205269
Beschreibung
5. The subject has a life expectancy of greater than 6 months.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0023671
Beschreibung
6. The subject has an ECOG Performance status of 0 to 2.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1520224
Beschreibung
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Beschreibung
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
Datentyp
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
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0565998
- UMLS CUI [2,1]
- C2700391
- UMLS CUI [2,2]
- C1507394
Beschreibung
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1321605
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C1554196
- UMLS CUI [1,5]
- C0086960
- UMLS CUI [1,6]
- C1709747
Beschreibung
11. The subject must understand and voluntarily sign an informed consent document.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C4034483
- UMLS CUI [1,2]
- C0700589
Beschreibung
13. The subject must have Adequate end organ function
Datentyp
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
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
1. Intolerance to resveratrol, SRT501, bortezomib, Boron, Mannitol or prior toxicity
Datentyp
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
Beschreibung
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0007117
- UMLS CUI [1,4]
- C0553723
Beschreibung
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.
Datentyp
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
Beschreibung
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0017178
- UMLS CUI [1,2]
- C4054723
- UMLS CUI [1,3]
- C0678745
Beschreibung
5. Breast Feeding | Pregnancy | Sex Behavior | Contraceptive methods; Appropriate | Serum pregnancy test negative; Serum Beta-HCG Test | Postmenopausal state | Female Sterilization
Datentyp
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
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C1522449
- UMLS CUI [3]
- C0021430
- UMLS CUI [4]
- C0877248
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C2827774
- UMLS CUI [2]
- C0032952
- UMLS CUI [3]
- C0020268
- UMLS CUI [4]
- C0456388
Beschreibung
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0242295
- UMLS CUI [2]
- C0949266
- UMLS CUI [3]
- C0073096
Beschreibung
9. The subject has peripheral neuropathy of Grade 2 or greater.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031117
Beschreibung
10. The subject has uncontrolled bleeding.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0019080
Beschreibung
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory.
Datentyp
integer
Alias
- UMLS CUI [1]
- C2748540
- UMLS CUI [2]
- C1390214
- UMLS CUI [3]
- C0005821
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0019046
- UMLS CUI [2]
- C1879316
- UMLS CUI [3]
- C0014822
Beschreibung
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1853129
Ähnliche Modelle
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])
C1554196 (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])