ID

15401

Beschreibung

An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-803 as a Single Agent and in Combination With Carboplatin in Subjects With Advanced Solid Tumors or Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02278250

Link

https://clinicaltrials.gov/show/NCT02278250

Stichworte

Versionen (1)
  1. 30.05.16 30.05.16 -
Hochgeladen am

30. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT02278250

Englisch

Eligibility Lymphoma NCT02278250

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02278250
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
part a: subjects with histologically or cytologically confirmed malignant advanced solid tumors or lymphoma, for whom either no standard therapy should be available which may convey clinical benefit, or
Beschreibung

Malignant solid tumour Advanced | Lymphoma Advanced | Standard therapy Unavailability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1698088
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0686905
part b: subjects with histologically or cytologically confirmed malignant advanced solid tumors or lymphoma, for whom no standard therapy should be available which may convey clinical benefit and/or patients must have progressed after at least 1 prior chemotherapy regimen in the metastatic setting, and carboplatin would be considered standard of care.
Beschreibung

Malignant solid tumour Advanced | Lymphoma Advanced | Standard therapy Unavailability | Prior Chemotherapy | Neoplasm Metastasis | Carboplatin Standard of Care

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1698088
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0686905
UMLS CUI [4]
C1514457
UMLS CUI [5]
C0027627
UMLS CUI [6,1]
C0079083
UMLS CUI [6,2]
C2936643
part c: subjects with advanced (locally advanced incurable or metastatic) histologically or cytologically confirmed high-grade serous ovarian cancer (high nuclear grades 2 or 3). subjects should have either platinum-refractory (disease progression during initial platinum therapy) or platinum-resistant (disease progression <6 months after completion of platinum therapy) disease.
Beschreibung

Ovarian Carcinoma Severe Advanced Locally Metastatic | Therapeutic procedure Platinum-based Drug | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C1517928
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2266918
UMLS CUI [3]
C0242656
measurable disease according to recist criteria (version 1.1)
Beschreibung

Measurable Disease Response Evaluation Criteria in Solid Tumors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1709926
who performance status of 0 or 1
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy of ≥12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
hematological and biochemical indices within acceptable ranges at screening.
Beschreibung

Index Hematologic | Index Biochemical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0918012
UMLS CUI [1,2]
C0205488
UMLS CUI [2,1]
C0918012
UMLS CUI [2,2]
C0205474
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiotherapy, unless brief course for palliative therapy, endocrine therapy, immunotherapy, or chemotherapy during the 4 weeks (6 weeks for nitrosoureas and mitomycin-c, and 4 weeks for investigational medicinal products) or 4 drug half-lives before first dose of study drug, whichever is greater
Beschreibung

Therapeutic radiology procedure | Palliative Radiation Therapy | Hormone Therapy | Immunotherapy | Chemotherapy Regimen | Nitrosourea Compounds | Mitomycin | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C3898008
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0392920
UMLS CUI [6]
C0028210
UMLS CUI [7]
C0002475
UMLS CUI [8]
C0013230
part b: more than 6 cycles of prior therapy with carboplatin
Beschreibung

Prior Therapy Carboplatin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0079083
parts b and c: during prior platinum therapy, requirement for dose reduction or discontinuation of carboplatin for toxicity or lack of tolerability
Beschreibung

Prior Therapy Platinum-based Drug | Carboplatin Unit dose Reduced | Carboplatin Unit dose Discontinued | Toxicity aspects | intolerance to substance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2266918
UMLS CUI [2,1]
C0079083
UMLS CUI [2,2]
C0869039
UMLS CUI [2,3]
C0392756
UMLS CUI [3,1]
C0079083
UMLS CUI [3,2]
C0869039
UMLS CUI [3,3]
C1444662
UMLS CUI [4]
C0040539
UMLS CUI [5]
C1744706
ongoing toxic manifestations of previous treatments. exceptions to this are alopecia or certain grade 1 toxicities, which in the opinion of the investigator should not exclude the subject
Beschreibung

Toxic effect Continuous Due to Prior Therapy | Alopecia | Mild Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1514463
UMLS CUI [2]
C0002170
UMLS CUI [3]
C1513302
a. any known history of grade 4 thrombocytopenia with any prior chemotherapy regimen
Beschreibung

Thrombocytopenia 4 | Prior Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C2677608
UMLS CUI [2]
C1514457
spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring steroids for at least 4 weeks before first dose of study drug
Beschreibung

Compression of spinal cord | Metastatic malignant neoplasm to brain | Steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0220650
UMLS CUI [3]
C0038317
female subjects who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. female subjects of childbearing potential must adhere to contraception guidelines. female subjects will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for over 2 years with a screening serum follicle-stimulating hormone (fsh) level within the laboratory's reference range for postmenopausal females.
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential | Contraceptive methods | Hysterectomy | Bilateral oophorectomy | Amenorrhea | Follicle stimulating hormone measurement | Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4]
C3831118
UMLS CUI [5]
C0700589
UMLS CUI [6]
C0020699
UMLS CUI [7]
C0278321
UMLS CUI [8]
C0002453
UMLS CUI [9]
C0202022
UMLS CUI [10]
C0232970
male subjects with partners of childbearing potential must agree to adhere to contraception guidelines. men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded.
Beschreibung

Gender | Partner in relationship Childbearing Potential | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
UMLS CUI [3]
C0700589
major surgery ≤4 weeks before first dose of study drug or incomplete recovery from a prior major surgical procedure
Beschreibung

major surgery | Investigational New Drugs | Major surgery Previous | Recovery Incomplete

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0679637
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C2004454
UMLS CUI [4,2]
C0205257
serious co-morbid medical conditions, including clinically-significant cardiac disease
Beschreibung

Comorbidity Serious | Heart Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018799
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Ähnliche Modelle

Eligibility Lymphoma NCT02278250

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02278250
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Malignant solid tumour Advanced | Lymphoma Advanced | Standard therapy Unavailability
Item
part a: subjects with histologically or cytologically confirmed malignant advanced solid tumors or lymphoma, for whom either no standard therapy should be available which may convey clinical benefit, or
boolean
C1698088 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
Malignant solid tumour Advanced | Lymphoma Advanced | Standard therapy Unavailability | Prior Chemotherapy | Neoplasm Metastasis | Carboplatin Standard of Care
Item
part b: subjects with histologically or cytologically confirmed malignant advanced solid tumors or lymphoma, for whom no standard therapy should be available which may convey clinical benefit and/or patients must have progressed after at least 1 prior chemotherapy regimen in the metastatic setting, and carboplatin would be considered standard of care.
boolean
C1698088 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4])
C0027627 (UMLS CUI [5])
C0079083 (UMLS CUI [6,1])
C2936643 (UMLS CUI [6,2])
Ovarian Carcinoma Severe Advanced Locally Metastatic | Therapeutic procedure Platinum-based Drug | Disease Progression
Item
part c: subjects with advanced (locally advanced incurable or metastatic) histologically or cytologically confirmed high-grade serous ovarian cancer (high nuclear grades 2 or 3). subjects should have either platinum-refractory (disease progression during initial platinum therapy) or platinum-resistant (disease progression <6 months after completion of platinum therapy) disease.
boolean
C0029925 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1517928 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C2266918 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
Measurable Disease Response Evaluation Criteria in Solid Tumors
Item
measurable disease according to recist criteria (version 1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
WHO performance status scale
Item
who performance status of 0 or 1
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of ≥12 weeks
boolean
C0023671 (UMLS CUI [1])
Index Hematologic | Index Biochemical
Item
hematological and biochemical indices within acceptable ranges at screening.
boolean
C0918012 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0918012 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Palliative Radiation Therapy | Hormone Therapy | Immunotherapy | Chemotherapy Regimen | Nitrosourea Compounds | Mitomycin | Investigational New Drugs
Item
radiotherapy, unless brief course for palliative therapy, endocrine therapy, immunotherapy, or chemotherapy during the 4 weeks (6 weeks for nitrosoureas and mitomycin-c, and 4 weeks for investigational medicinal products) or 4 drug half-lives before first dose of study drug, whichever is greater
boolean
C1522449 (UMLS CUI [1])
C3898008 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C0028210 (UMLS CUI [6])
C0002475 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Prior Therapy Carboplatin
Item
part b: more than 6 cycles of prior therapy with carboplatin
boolean
C1514463 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
Prior Therapy Platinum-based Drug | Carboplatin Unit dose Reduced | Carboplatin Unit dose Discontinued | Toxicity aspects | intolerance to substance
Item
parts b and c: during prior platinum therapy, requirement for dose reduction or discontinuation of carboplatin for toxicity or lack of tolerability
boolean
C1514463 (UMLS CUI [1,1])
C2266918 (UMLS CUI [1,2])
C0079083 (UMLS CUI [2,1])
C0869039 (UMLS CUI [2,2])
C0392756 (UMLS CUI [2,3])
C0079083 (UMLS CUI [3,1])
C0869039 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0040539 (UMLS CUI [4])
C1744706 (UMLS CUI [5])
Toxic effect Continuous Due to Prior Therapy | Alopecia | Mild Adverse Event
Item
ongoing toxic manifestations of previous treatments. exceptions to this are alopecia or certain grade 1 toxicities, which in the opinion of the investigator should not exclude the subject
boolean
C0600688 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
C0002170 (UMLS CUI [2])
C1513302 (UMLS CUI [3])
Thrombocytopenia 4 | Prior Chemotherapy
Item
a. any known history of grade 4 thrombocytopenia with any prior chemotherapy regimen
boolean
C2677608 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
Compression of spinal cord | Metastatic malignant neoplasm to brain | Steroids
Item
spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring steroids for at least 4 weeks before first dose of study drug
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential | Contraceptive methods | Hysterectomy | Bilateral oophorectomy | Amenorrhea | Follicle stimulating hormone measurement | Postmenopausal state
Item
female subjects who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. female subjects of childbearing potential must adhere to contraception guidelines. female subjects will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for over 2 years with a screening serum follicle-stimulating hormone (fsh) level within the laboratory's reference range for postmenopausal females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
C0002453 (UMLS CUI [8])
C0202022 (UMLS CUI [9])
C0232970 (UMLS CUI [10])
Gender | Partner in relationship Childbearing Potential | Contraceptive methods
Item
male subjects with partners of childbearing potential must agree to adhere to contraception guidelines. men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded.
boolean
C0079399 (UMLS CUI [1])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3])
major surgery | Investigational New Drugs | Major surgery Previous | Recovery Incomplete
Item
major surgery ≤4 weeks before first dose of study drug or incomplete recovery from a prior major surgical procedure
boolean
C0679637 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0679637 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C2004454 (UMLS CUI [4,1])
C0205257 (UMLS CUI [4,2])
Comorbidity Serious | Heart Diseases
Item
serious co-morbid medical conditions, including clinically-significant cardiac disease
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
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