ID

35882

Descripción

INC280 Combined With Bevacizumab to Evaluate Glioblastoma Multiforme, Metastatic Colorectal Cancer, and Metastatic Renal Cell Carcinoma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02386826

Link

https://clinicaltrials.gov/show/NCT02386826

Palabras clave

Versiones (1)
  1. 1/4/19 1/4/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Glioblastoma Multiforme NCT02386826

Inglés

Eligibility Glioblastoma Multiforme NCT02386826

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
key points:
Descripción

Criteria Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1542147
1. dose escalation phase: histologic diagnosis of gbm or gliosarcoma. progressed during or after standard ≥ 1st-line therapy for gbm. patients scheduled to undergo a repeat primary surgical resection are also eligible. measurable disease as measured by rano (response assessment in neuro-oncology) criteria
Descripción

Dose Escalation Phase | Glioblastoma | Gliosarcoma | Therapeutic procedure Glioblastoma | Disease Progression | Excision Primary Repeat Scheduled | Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3816728
UMLS CUI [1,2]
C1710475
UMLS CUI [2]
C0017636
UMLS CUI [3]
C0206726
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0017636
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C0728940
UMLS CUI [6,2]
C0205225
UMLS CUI [6,3]
C0205341
UMLS CUI [6,4]
C0205539
UMLS CUI [7]
C1513041
2. dose expansion phase:
Descripción

Dose Expanded Phase

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205229
UMLS CUI [1,3]
C1710475
cohort a: histologic diagnosis of gbm or gliosarcoma. progressed during or after standard ≥ 1st-line therapy for gbm. patients scheduled to undergo a repeat primary surgical resection are also eligible. measurable disease as measured by rano criteria
Descripción

Cohort Specified | Glioblastoma | Gliosarcoma | Therapeutic procedure Glioblastoma | Disease Progression | Excision Primary Repeat Scheduled | Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C0017636
UMLS CUI [3]
C0206726
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0017636
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C0728940
UMLS CUI [6,2]
C0205225
UMLS CUI [6,3]
C0205341
UMLS CUI [6,4]
C0205539
UMLS CUI [7]
C1513041
cohort b: metastatic colorectal cancer (mcrc) patients after progression on ≥
Descripción

Cohort Specified | Secondary malignant neoplasm of large intestine | Status post Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C0346973
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0242656
2nd-line therapy for advanced disease. measurable disease as measured by recist (response evaluation criteria in solid tumors) v1.1
Descripción

Second line treatment Advanced disease | Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C0679246
UMLS CUI [2]
C1513041
cohort c: metastatic renal cell carcinoma (mrcc) (with clear cell component) patients after progression on ≥ 1st-line therapy for advanced disease. measurable disease as measured by recist v 1.1
Descripción

Cohort Specified | Clear-cell metastatic renal cell carcinoma | Status post Disease Progression | Therapeutic procedure Advanced disease | Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C2931852
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0242656
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0679246
UMLS CUI [5]
C1513041
at least 5 patients in each of the above 3 cohorts must have alteration of met [as assessed by fish (c-met/centromere ratio ≥2, or c-met gene copy number ≥ 5) or rt-pcr or met ihc score of 2-3+ or a mutation].
Descripción

MET Gene Mutation FISH | MET gene Centromere Ratio | MET gene Copy Number | Reverse Transcriptase Polymerase Chain Reaction | MET gene Immunohistochemistry | MET Gene Mutation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1518121
UMLS CUI [1,2]
C0162789
UMLS CUI [2,1]
C1417123
UMLS CUI [2,2]
C0007709
UMLS CUI [2,3]
C0456603
UMLS CUI [3,1]
C1417123
UMLS CUI [3,2]
C1707513
UMLS CUI [4]
C0599161
UMLS CUI [5,1]
C1417123
UMLS CUI [5,2]
C0021044
UMLS CUI [6]
C1518121
3. eastern cooperative oncology group (ecog) performance status score of 0-2 or karnofsky performance scale (kps) >70%
Descripción

ECOG performance status | Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
4. adequate hematologic, renal and liver function
Descripción

Hematologic function | Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
5. life expectancy ≥ 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
6. availability of archived tumor samples and/or willingness to provide tissue samples if resection is done. (fresh tissue biopsy is not required if archival tissue is not available.)
Descripción

Availability of Tumor tissue sample | Tissue specimen Provide Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C1999230
UMLS CUI [2,3]
C0600109
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with bevacizumab or any other vegf or vegfr inhibitors for gbm patients; prior treatment with bevacizumab for mrcc patients. (prior treatment with bevacizumab is permitted for mcrc patients)
Descripción

bevacizumab | Vascular Endothelial Growth Factor Inhibitor | VEGFR Tyrosine Kinase Inhibitor | Therapeutic procedure Glioblastoma | Prior Therapy Metastatic Renal Cell Cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2]
C4521299
UMLS CUI [3]
C2985521
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0017636
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C0278678
2. uncontrolled seizures (patients with a history of seizures are eligible if they are currently without seizures on a stable dose of anti-epileptic drugs for 14 days prior to enrollment.)
Descripción

Seizures Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
3. history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
Descripción

Hemorrhage Hereditary Uncontrolled | Hemorrhage Acquired | Thrombosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0439660
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0439661
UMLS CUI [3]
C0040053
4. a serious non healing wound, ulcer, or bone fracture ≤ 28 days to the start of treatment
Descripción

Wound, non-healed | Ulcer | Fracture

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0750433
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
5. wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤ 28 days or limited field radiation for palliation ≤ 7 days prior to starting study drug or has not recovered from side effects of such therapy.
Descripción

Therapeutic radiology procedure Field Wide | Strontium-89 | Therapeutic radiology procedure Field Limited Palliative Care | Side effects Recovery Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C0332464
UMLS CUI [2]
C0281385
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1882536
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C0030231
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C2004454
UMLS CUI [4,3]
C0332268
6. leptomeningeal metastases or spinal cord compression due to disease. (mrcc and mcrc patients with stable treated metastases will be allowed to enroll.)
Descripción

Metastatic Malignant Neoplasm to the Leptomeninges | Compression of spinal cord Due to Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1704231
UMLS CUI [2,1]
C0037926
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0012634
7. women of child-bearing potential.
Descripción

Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
8. receiving drugs known to be strong inhibitors or inducers of cyp3a4 and cannot be discontinued 7 days prior to the start of inc280 treatment and during the course of the study, or medications that are known cyp3a4, cyp1a2, cyp2c8, cyp2c9 or cyp2c19 substrates with narrow therapeutic index, and cannot be discontinued during the course of the study.
Descripción

CYP3A4 Inhibitors | CYP3A4 Inducers | CYP3A4 Substrate | CYP1A2 Substrate | CYP2C8 Substrate | CYP2C9 Substrate | CYP2C19 Substrate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C3850041
UMLS CUI [3,1]
C3714798
UMLS CUI [3,2]
C3891814
UMLS CUI [4,1]
C0207509
UMLS CUI [4,2]
C3891814
UMLS CUI [5,1]
C1382144
UMLS CUI [5,2]
C3891814
UMLS CUI [6,1]
C1828473
UMLS CUI [6,2]
C3891814
UMLS CUI [7,1]
C3714749
UMLS CUI [7,2]
C3891814
9. treatment with proton pump inhibitors within three days prior to study entry.
Descripción

Proton Pump Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0358591
10. cardiac disease currently or less than 6 months from baseline screening
Descripción

Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
11. inadequately controlled hypertension (i.e., systolic blood pressure [sbp] >180 mmhg or diastolic blood pressure (dbp) >100 mmhg) (patients with values above these levels must have their blood pressure (bp) controlled with medication prior to starting treatment).
Descripción

Poor hypertension control | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents High blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0020538
12. currently receiving treatment with therapeutic doses of warfarin sodium. low molecular weight heparin is allowed.
Descripción

Warfarin Sodium | Low-Molecular-Weight Heparin allowed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0376218
UMLS CUI [2,1]
C0019139
UMLS CUI [2,2]
C0683607
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Similar models

Eligibility Glioblastoma Multiforme NCT02386826

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Main
Item
key points:
boolean
C0243161 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Dose Escalation Phase | Glioblastoma | Gliosarcoma | Therapeutic procedure Glioblastoma | Disease Progression | Excision Primary Repeat Scheduled | Measurable Disease
Item
1. dose escalation phase: histologic diagnosis of gbm or gliosarcoma. progressed during or after standard ≥ 1st-line therapy for gbm. patients scheduled to undergo a repeat primary surgical resection are also eligible. measurable disease as measured by rano (response assessment in neuro-oncology) criteria
boolean
C3816728 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C0017636 (UMLS CUI [2])
C0206726 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0017636 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5])
C0728940 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C0205341 (UMLS CUI [6,3])
C0205539 (UMLS CUI [6,4])
C1513041 (UMLS CUI [7])
Dose Expanded Phase
Item
2. dose expansion phase:
boolean
C0178602 (UMLS CUI [1,1])
C0205229 (UMLS CUI [1,2])
C1710475 (UMLS CUI [1,3])
Cohort Specified | Glioblastoma | Gliosarcoma | Therapeutic procedure Glioblastoma | Disease Progression | Excision Primary Repeat Scheduled | Measurable Disease
Item
cohort a: histologic diagnosis of gbm or gliosarcoma. progressed during or after standard ≥ 1st-line therapy for gbm. patients scheduled to undergo a repeat primary surgical resection are also eligible. measurable disease as measured by rano criteria
boolean
C0599755 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0017636 (UMLS CUI [2])
C0206726 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0017636 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5])
C0728940 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C0205341 (UMLS CUI [6,3])
C0205539 (UMLS CUI [6,4])
C1513041 (UMLS CUI [7])
Cohort Specified | Secondary malignant neoplasm of large intestine | Status post Disease Progression
Item
cohort b: metastatic colorectal cancer (mcrc) patients after progression on ≥
boolean
C0599755 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0346973 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
Second line treatment Advanced disease | Measurable Disease
Item
2nd-line therapy for advanced disease. measurable disease as measured by recist (response evaluation criteria in solid tumors) v1.1
boolean
C1710038 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2])
Cohort Specified | Clear-cell metastatic renal cell carcinoma | Status post Disease Progression | Therapeutic procedure Advanced disease | Measurable Disease
Item
cohort c: metastatic renal cell carcinoma (mrcc) (with clear cell component) patients after progression on ≥ 1st-line therapy for advanced disease. measurable disease as measured by recist v 1.1
boolean
C0599755 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C2931852 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0679246 (UMLS CUI [4,2])
C1513041 (UMLS CUI [5])
MET Gene Mutation FISH | MET gene Centromere Ratio | MET gene Copy Number | Reverse Transcriptase Polymerase Chain Reaction | MET gene Immunohistochemistry | MET Gene Mutation
Item
at least 5 patients in each of the above 3 cohorts must have alteration of met [as assessed by fish (c-met/centromere ratio ≥2, or c-met gene copy number ≥ 5) or rt-pcr or met ihc score of 2-3+ or a mutation].
boolean
C1518121 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1417123 (UMLS CUI [2,1])
C0007709 (UMLS CUI [2,2])
C0456603 (UMLS CUI [2,3])
C1417123 (UMLS CUI [3,1])
C1707513 (UMLS CUI [3,2])
C0599161 (UMLS CUI [4])
C1417123 (UMLS CUI [5,1])
C0021044 (UMLS CUI [5,2])
C1518121 (UMLS CUI [6])
ECOG performance status | Karnofsky Performance Status
Item
3. eastern cooperative oncology group (ecog) performance status score of 0-2 or karnofsky performance scale (kps) >70%
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Hematologic function | Renal function | Liver function
Item
4. adequate hematologic, renal and liver function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Life Expectancy
Item
5. life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Availability of Tumor tissue sample | Tissue specimen Provide Willing
Item
6. availability of archived tumor samples and/or willingness to provide tissue samples if resection is done. (fresh tissue biopsy is not required if archival tissue is not available.)
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1292533 (UMLS CUI [2,1])
C1999230 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
bevacizumab | Vascular Endothelial Growth Factor Inhibitor | VEGFR Tyrosine Kinase Inhibitor | Therapeutic procedure Glioblastoma | Prior Therapy Metastatic Renal Cell Cancer
Item
1. prior treatment with bevacizumab or any other vegf or vegfr inhibitors for gbm patients; prior treatment with bevacizumab for mrcc patients. (prior treatment with bevacizumab is permitted for mcrc patients)
boolean
C0796392 (UMLS CUI [1])
C4521299 (UMLS CUI [2])
C2985521 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0017636 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C0278678 (UMLS CUI [5,2])
Seizures Uncontrolled
Item
2. uncontrolled seizures (patients with a history of seizures are eligible if they are currently without seizures on a stable dose of anti-epileptic drugs for 14 days prior to enrollment.)
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hemorrhage Hereditary Uncontrolled | Hemorrhage Acquired | Thrombosis
Item
3. history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
boolean
C0019080 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0019080 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
C0040053 (UMLS CUI [3])
Wound, non-healed | Ulcer | Fracture
Item
4. a serious non healing wound, ulcer, or bone fracture ≤ 28 days to the start of treatment
boolean
C0750433 (UMLS CUI [1])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Therapeutic radiology procedure Field Wide | Strontium-89 | Therapeutic radiology procedure Field Limited Palliative Care | Side effects Recovery Lacking
Item
5. wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤ 28 days or limited field radiation for palliation ≤ 7 days prior to starting study drug or has not recovered from side effects of such therapy.
boolean
C1522449 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0332464 (UMLS CUI [1,3])
C0281385 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C1882536 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0030231 (UMLS CUI [3,4])
C0879626 (UMLS CUI [4,1])
C2004454 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Metastatic Malignant Neoplasm to the Leptomeninges | Compression of spinal cord Due to Disease
Item
6. leptomeningeal metastases or spinal cord compression due to disease. (mrcc and mcrc patients with stable treated metastases will be allowed to enroll.)
boolean
C1704231 (UMLS CUI [1])
C0037926 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
Childbearing Potential
Item
7. women of child-bearing potential.
boolean
C3831118 (UMLS CUI [1])
CYP3A4 Inhibitors | CYP3A4 Inducers | CYP3A4 Substrate | CYP1A2 Substrate | CYP2C8 Substrate | CYP2C9 Substrate | CYP2C19 Substrate
Item
8. receiving drugs known to be strong inhibitors or inducers of cyp3a4 and cannot be discontinued 7 days prior to the start of inc280 treatment and during the course of the study, or medications that are known cyp3a4, cyp1a2, cyp2c8, cyp2c9 or cyp2c19 substrates with narrow therapeutic index, and cannot be discontinued during the course of the study.
boolean
C3850053 (UMLS CUI [1])
C3850041 (UMLS CUI [2])
C3714798 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0207509 (UMLS CUI [4,1])
C3891814 (UMLS CUI [4,2])
C1382144 (UMLS CUI [5,1])
C3891814 (UMLS CUI [5,2])
C1828473 (UMLS CUI [6,1])
C3891814 (UMLS CUI [6,2])
C3714749 (UMLS CUI [7,1])
C3891814 (UMLS CUI [7,2])
Proton Pump Inhibitors
Item
9. treatment with proton pump inhibitors within three days prior to study entry.
boolean
C0358591 (UMLS CUI [1])
Heart Disease
Item
10. cardiac disease currently or less than 6 months from baseline screening
boolean
C0018799 (UMLS CUI [1])
Poor hypertension control | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents High blood pressure
Item
11. inadequately controlled hypertension (i.e., systolic blood pressure [sbp] >180 mmhg or diastolic blood pressure (dbp) >100 mmhg) (patients with values above these levels must have their blood pressure (bp) controlled with medication prior to starting treatment).
boolean
C0421190 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0003364 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
Warfarin Sodium | Low-Molecular-Weight Heparin allowed
Item
12. currently receiving treatment with therapeutic doses of warfarin sodium. low molecular weight heparin is allowed.
boolean
C0376218 (UMLS CUI [1])
C0019139 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
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