ID

40995

Description

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01202591

Link

https://clinicaltrials.gov/show/NCT01202591

Keywords

Versions (1)
  1. 6/9/20 6/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 9, 2020

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License

Creative Commons BY 4.0
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Eligibility FGFR Inhibition, Pharmacokinetics, Biomarkers NCT01202591

English

Eligibility FGFR Inhibition, Pharmacokinetics, Biomarkers NCT01202591

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
Description

Postmenopausal state | Bilateral oophorectomy | Amenorrhea Duration

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0278321
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
histological confirmation of breast cancer with documented er+ receptor status
Description

Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C2938924
safety run-in: relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal ai and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal al
Description

Relapse | Hormone Therapy Adjuvant Completed | Anti-Inflammatory Agents, Non-Steroidal | Tamoxifen | Disease Progression | Status post First line Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C0205197
UMLS CUI [3]
C0003211
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1708063
UMLS CUI [6,3]
C0279025
rand phase iia: received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal ai or tamoxifen or a combination of both). chemotherapy administered in the adjuvant setting is permitted.
Description

Hormone Therapy Quantity Metastatic Setting | Relapse | Hormone Therapy Adjuvant Completed | Anti-Inflammatory Agents, Non-Steroidal | Tamoxifen | Combined Modality Therapy | Chemotherapy Adjuvant Setting allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C4085632
UMLS CUI [2]
C0035020
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C1522673
UMLS CUI [3,3]
C0205197
UMLS CUI [4]
C0003211
UMLS CUI [5]
C0039286
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C0392920
UMLS CUI [7,2]
C4084850
UMLS CUI [7,3]
C0683607
rand phase iia: mandatory provision of tumour sample to confirm fgfr1 polysomy or gene amplification. at least one measurable lesion that can be accurately assessed by ct/mri/x-ray at baseline and follow up visits
Description

Tumor tissue sample mandatory | FGFR1 Polysomy | FGFR1 Gene Amplification | Measurable lesion Quantity CT | Measurable lesion Quantity MRI | Measurable lesion Quantity X-Ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0919509
UMLS CUI [2,2]
C1514212
UMLS CUI [3,1]
C0919509
UMLS CUI [3,2]
C0017256
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0024485
UMLS CUI [6,1]
C1513041
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0043299
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase iia), or any agent known to inhibit fgfrs.
Description

Exposure to Exemestane | Exposure to Fulvestrant | Exposure to FGFR Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0851344
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0935916
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0060369
UMLS CUI [3,3]
C1999216
more than 1 prior regimen of chemotherapy for breast cancer
Description

Prior Chemotherapy Quantity Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0678222
ecg recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
Description

Abnormal heart rate Electrocardiography | Cardiac Arrhythmia Electrocardiography | Abnormal cardiac conduction Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1744601
UMLS CUI [1,2]
C1623258
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C1623258
UMLS CUI [3,1]
C0232219
UMLS CUI [3,2]
C1623258
history of hypersensitivity to active or inactive excipients of azd4547 or exemestane (safety run-in ) or fulvestrant (randomized phase), including castor oil, or drugs with a similar chemical structure or class to azd4547 or exemestane or fulvestrant.
Description

Hypersensitivity Excipient AZD4547 | Hypersensitivity Excipient Exemestane | Hypersensitivity Excipient Fulvestrant | Hypersensitivity Excipient Castor Oil | Hypersensitivity Drug Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0015237
UMLS CUI [1,3]
C2981795
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
UMLS CUI [2,3]
C0851344
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
UMLS CUI [3,3]
C0935916
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0015237
UMLS CUI [4,3]
C0007343
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1254351
UMLS CUI [5,3]
C2348205
randomized phase iia: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
Description

Hemorrhage | Blood Clotting | Fulvestrant Injection Buttocks Preventing

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0302148
UMLS CUI [3,1]
C0935916
UMLS CUI [3,2]
C1828121
UMLS CUI [3,3]
C0006497
UMLS CUI [3,4]
C1292733
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Similar models

Eligibility FGFR Inhibition, Pharmacokinetics, Biomarkers NCT01202591

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Bilateral oophorectomy | Amenorrhea Duration
Item
post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
boolean
C0232970 (UMLS CUI [1])
C0278321 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Oestrogen receptor positive breast cancer
Item
histological confirmation of breast cancer with documented er+ receptor status
boolean
C2938924 (UMLS CUI [1])
Relapse | Hormone Therapy Adjuvant Completed | Anti-Inflammatory Agents, Non-Steroidal | Tamoxifen | Disease Progression | Status post First line Hormone Therapy
Item
safety run-in: relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal ai and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal al
boolean
C0035020 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0003211 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
C0242656 (UMLS CUI [5])
C0231290 (UMLS CUI [6,1])
C1708063 (UMLS CUI [6,2])
C0279025 (UMLS CUI [6,3])
Hormone Therapy Quantity Metastatic Setting | Relapse | Hormone Therapy Adjuvant Completed | Anti-Inflammatory Agents, Non-Steroidal | Tamoxifen | Combined Modality Therapy | Chemotherapy Adjuvant Setting allowed
Item
rand phase iia: received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal ai or tamoxifen or a combination of both). chemotherapy administered in the adjuvant setting is permitted.
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4085632 (UMLS CUI [1,3])
C0035020 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0003211 (UMLS CUI [4])
C0039286 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C0392920 (UMLS CUI [7,1])
C4084850 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
Tumor tissue sample mandatory | FGFR1 Polysomy | FGFR1 Gene Amplification | Measurable lesion Quantity CT | Measurable lesion Quantity MRI | Measurable lesion Quantity X-Ray
Item
rand phase iia: mandatory provision of tumour sample to confirm fgfr1 polysomy or gene amplification. at least one measurable lesion that can be accurately assessed by ct/mri/x-ray at baseline and follow up visits
boolean
C0475358 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0919509 (UMLS CUI [2,1])
C1514212 (UMLS CUI [2,2])
C0919509 (UMLS CUI [3,1])
C0017256 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1513041 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C1513041 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0043299 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Exposure to Exemestane | Exposure to Fulvestrant | Exposure to FGFR Inhibitor
Item
prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase iia), or any agent known to inhibit fgfrs.
boolean
C0332157 (UMLS CUI [1,1])
C0851344 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0935916 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0060369 (UMLS CUI [3,2])
C1999216 (UMLS CUI [3,3])
Prior Chemotherapy Quantity Breast Carcinoma
Item
more than 1 prior regimen of chemotherapy for breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Abnormal heart rate Electrocardiography | Cardiac Arrhythmia Electrocardiography | Abnormal cardiac conduction Electrocardiography
Item
ecg recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
boolean
C1744601 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C0232219 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
Hypersensitivity Excipient AZD4547 | Hypersensitivity Excipient Exemestane | Hypersensitivity Excipient Fulvestrant | Hypersensitivity Excipient Castor Oil | Hypersensitivity Drug Similar
Item
history of hypersensitivity to active or inactive excipients of azd4547 or exemestane (safety run-in ) or fulvestrant (randomized phase), including castor oil, or drugs with a similar chemical structure or class to azd4547 or exemestane or fulvestrant.
boolean
C0020517 (UMLS CUI [1,1])
C0015237 (UMLS CUI [1,2])
C2981795 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C0851344 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
C0935916 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
C0007343 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C1254351 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
Hemorrhage | Blood Clotting | Fulvestrant Injection Buttocks Preventing
Item
randomized phase iia: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
boolean
C0019080 (UMLS CUI [1])
C0302148 (UMLS CUI [2])
C0935916 (UMLS CUI [3,1])
C1828121 (UMLS CUI [3,2])
C0006497 (UMLS CUI [3,3])
C1292733 (UMLS CUI [3,4])
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