Clinical Trials List
Protocol Number42756493LUC2001
2016-06-07 - 2020-03-31
Phase II
Not yet recruiting1
Terminated4
Study ended1
ICD-10C68.9
Malignant neoplasm of urinary organ, unspecified
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10C7A.092
Malignant carcinoid tumor of the stomach
ICD-10C15.9
Malignant neoplasm of esophagus, unspecified
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Phase 2a Study to evaluate the clinical efficacy of JNJ-42756493(erdafitinib), a pan-Fibroblast Growth Factor Receptor (FGFR) tyrosine kinase inhibitor, in Asian patients with advanced non-small-cell lung cancer, urothelial cancer, esophageal cancer, or cholangiocarcinoma.
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Trial Applicant
Johnson & Johnson
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Wei-Pang Chung Division of Hematology & Oncology
- Wen-Pin Su Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Nai-Jung Chiang Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳彥豪 Division of Hematology & Oncology
- 黃泰霖 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 歐信佑 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Shang-Wen Chen Division of Hematology & Oncology
- 高婉真 Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
- 林正耀 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 蕭聖諺 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- San-Chi Chen Division of Hematology & Oncology
- Rheun-Chuan Lee Division of Radiology
- Yee Chao Division of Hematology & Oncology
- 林泰祺 Division of Ophthalmology
- Chung-Pin Li Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- Chi-Ching Chen 未分科
- Chang-Fang Chiu Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
- Wei-Ching Lin 未分科
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
advanced non-small-cell lung cancer, urothelial cancer, esophageal cancer, or cholangiocarcinoma
Objectives
To evaluate objective response rate (ORR) as per RECIST 1.1 of erdafitinib 8 mg once daily (QD) in a molecularly-defined subset of Asian subjects with non-small-cell lung cancer (NSCLC), urothelial cancer, esophageal cancer, and cholangiocarcinoma
Test Drug
JNJ-42756493
Active Ingredient
Dosage Form
Dosage
3/4/5
Endpoints
Primary Endpoint(s)
The primary endpoint is objective response rate (ORR).
Disease control rate (DCR), calculated from the proportion of subjects with CR,
PR or ≥6 weeks SD (stable disease).
The primary endpoint is objective response rate (ORR).
Disease control rate (DCR), calculated from the proportion of subjects with CR,
PR or ≥6 weeks SD (stable disease).
Inclution Criteria
Subjects must meet the molecular eligibility as well as full study eligibility criteria. Subjects with NSCLC or selected solid tumors (urothelial cancer, esophageal cancer and cholangiocarcinoma) are eligible for enrollment. Furthermore, subjects must have the presence of measurable disease according to RECIST (version 1.1), ECOG 0 or 1 and adequate bone marrow, liver, and renal function as defined in the Inclusion and Exclusion criteria.
Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating in
the study.
1 Criterion modified per amendment
1.1 Chemotherapy, targeted therapies, immunotherapy, or treatment with an
investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug,
whichever is longer but up to a maximum of 4 weeks, before the first administration of
study drug. Localized palliative radiation therapy (but should not include radiation to
target lesions) and ongoing luteinizing hormone-releasing hormone (LHRH) agonists,
bisphosphonates and denosumab, are permitted.
2 Subjects with persistent phosphate >ULN during screening (within 14 days prior to
Day 1 of Cycle 1 up until pre-dose of Cycle 1) and despite medical management of
phosphate levels.
3 History or current condition of uncontrolled cardiovascular disease including:
a. Unstable angina, myocardial infarction, or congestive heart failure Class II-IV
(Attachment 3) within the preceding 12 months, cerebrovascular accident
(CVA), transient ischemic attack (TIA) within the preceding 3 months,
pulmonary embolism (PE) within the preceding 2 months.
b. History of any of the following: sustained ventricular tachycardia, ventricular
fibrillation, Torsades de Pointes, cardiac arrest, Mobitz II second degree heart
block or third degree heart block; known presence of dilated, hypertrophic, or
restrictive cardiomyopathy.
c. Obligate use of a cardiac pacemaker or any other cardiac abnormality that, in
the opinion of the investigator, medical monitor, or study consultant
cardiologist, may place the subject at an unacceptable increased risk with the
study drug.
d. Diagnosed or suspected congenital long QT syndrome.
e. QTc prolongation as confirmed by triplicate assessment at screening
(Fridericia; QTc >450 ms in males or >470 milliseconds in females).
f. Family history of short QT syndrome, long QT syndrome
4 Subjects taking medications known to have a significant risk of causing QTc
prolongation and Torsades de Pointes. Subjects who have discontinued any of these
medications must have a wash-out period of at least 5 days or at least 5 half-lives of the
drug (whichever is longer) prior to the first dose of study drug (see reference in
Attachment 4).
5 Left ventricular ejection fraction (LVEF) <50% as assessed by echocardiography (or
MUGA) performed at screening.
6 Uncontrolled inter-current illness including, but not limited to, poorly controlled
hypertension or diabetes, ongoing active infection requiring antibiotics, psychiatric
illness, or at risk of gastrointestinal perforation as per investigators’ assessment.
7 Females who are pregnant, or breast-feeding, or planning to become pregnant and males
who plan to father a child while enrolled in this study or within 5 months after the last
dose of study drug.
8 Not recovered from reversible toxicity of prior anticancer therapy (except toxicities
which are not clinically significant such as alopecia, skin discoloration, or Grade 1
neuropathy).
Any medical condition that requires intact wound healing capacity and is expected to
endanger subject safety if wound healing capacity would be severely reduced during
administration of the investigational agent (eg, chronic leg ulcers, gastric ulcer disease,
skin/decubitus ulcers, or unhealed incisions, or expected major surgery while the
investigational agent is being administered).
10 Major surgery within 4 weeks before enrollment.
11 Known human immunodeficiency virus (HIV) infection, or evidence of active hepatitis
B or C infection (for example, subjects with history of hepatitis C infection but normal
hepatitis C virus polymerase chain reaction test and subjects with hepatitis B with
positive HBsAg antibody are allowed).
12 Active, symptomatic, or untreated brain metastases (subject with prior brain metastases
treated at least 3 weeks prior to signing the full-study Informed Consent Form [ICF] or
that are clinically and radiographically stable for at least 1 month prior to Cycle 1 Day 1
and do not require chronic corticosteroid treatment are allowed to be enrolled).
13 Criterion modified per amendment
13.1 Received prior selective FGFR inhibitor treatment or RET inhibitor treatment,
respectively according to the biomarker prescreening result, or the subject has known
allergies, hypersensitivity, or intolerance to erdafitinib or its excipients.
14 Exclusion criteria based on ophthalmologic exams
Any corneal or retinal abnormality likely to increase risk of eye toxicity such as but not
but not limited to:
a. History of or current evidence of central serous retinopathy (CSR) or retinal
vein occlusion (RVO)
b. Active wet, age related macular degeneration (AMD)
c. Diabetic retinopathy with macular edema
d. Uncontrolled glaucoma (as per local standard of care)
e. Corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal
abrasion, inflammation or ulceration.
the study.
1 Criterion modified per amendment
1.1 Chemotherapy, targeted therapies, immunotherapy, or treatment with an
investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug,
whichever is longer but up to a maximum of 4 weeks, before the first administration of
study drug. Localized palliative radiation therapy (but should not include radiation to
target lesions) and ongoing luteinizing hormone-releasing hormone (LHRH) agonists,
bisphosphonates and denosumab, are permitted.
2 Subjects with persistent phosphate >ULN during screening (within 14 days prior to
Day 1 of Cycle 1 up until pre-dose of Cycle 1) and despite medical management of
phosphate levels.
3 History or current condition of uncontrolled cardiovascular disease including:
a. Unstable angina, myocardial infarction, or congestive heart failure Class II-IV
(Attachment 3) within the preceding 12 months, cerebrovascular accident
(CVA), transient ischemic attack (TIA) within the preceding 3 months,
pulmonary embolism (PE) within the preceding 2 months.
b. History of any of the following: sustained ventricular tachycardia, ventricular
fibrillation, Torsades de Pointes, cardiac arrest, Mobitz II second degree heart
block or third degree heart block; known presence of dilated, hypertrophic, or
restrictive cardiomyopathy.
c. Obligate use of a cardiac pacemaker or any other cardiac abnormality that, in
the opinion of the investigator, medical monitor, or study consultant
cardiologist, may place the subject at an unacceptable increased risk with the
study drug.
d. Diagnosed or suspected congenital long QT syndrome.
e. QTc prolongation as confirmed by triplicate assessment at screening
(Fridericia; QTc >450 ms in males or >470 milliseconds in females).
f. Family history of short QT syndrome, long QT syndrome
4 Subjects taking medications known to have a significant risk of causing QTc
prolongation and Torsades de Pointes. Subjects who have discontinued any of these
medications must have a wash-out period of at least 5 days or at least 5 half-lives of the
drug (whichever is longer) prior to the first dose of study drug (see reference in
Attachment 4).
5 Left ventricular ejection fraction (LVEF) <50% as assessed by echocardiography (or
MUGA) performed at screening.
6 Uncontrolled inter-current illness including, but not limited to, poorly controlled
hypertension or diabetes, ongoing active infection requiring antibiotics, psychiatric
illness, or at risk of gastrointestinal perforation as per investigators’ assessment.
7 Females who are pregnant, or breast-feeding, or planning to become pregnant and males
who plan to father a child while enrolled in this study or within 5 months after the last
dose of study drug.
8 Not recovered from reversible toxicity of prior anticancer therapy (except toxicities
which are not clinically significant such as alopecia, skin discoloration, or Grade 1
neuropathy).
Any medical condition that requires intact wound healing capacity and is expected to
endanger subject safety if wound healing capacity would be severely reduced during
administration of the investigational agent (eg, chronic leg ulcers, gastric ulcer disease,
skin/decubitus ulcers, or unhealed incisions, or expected major surgery while the
investigational agent is being administered).
10 Major surgery within 4 weeks before enrollment.
11 Known human immunodeficiency virus (HIV) infection, or evidence of active hepatitis
B or C infection (for example, subjects with history of hepatitis C infection but normal
hepatitis C virus polymerase chain reaction test and subjects with hepatitis B with
positive HBsAg antibody are allowed).
12 Active, symptomatic, or untreated brain metastases (subject with prior brain metastases
treated at least 3 weeks prior to signing the full-study Informed Consent Form [ICF] or
that are clinically and radiographically stable for at least 1 month prior to Cycle 1 Day 1
and do not require chronic corticosteroid treatment are allowed to be enrolled).
13 Criterion modified per amendment
13.1 Received prior selective FGFR inhibitor treatment or RET inhibitor treatment,
respectively according to the biomarker prescreening result, or the subject has known
allergies, hypersensitivity, or intolerance to erdafitinib or its excipients.
14 Exclusion criteria based on ophthalmologic exams
Any corneal or retinal abnormality likely to increase risk of eye toxicity such as but not
but not limited to:
a. History of or current evidence of central serous retinopathy (CSR) or retinal
vein occlusion (RVO)
b. Active wet, age related macular degeneration (AMD)
c. Diabetic retinopathy with macular edema
d. Uncontrolled glaucoma (as per local standard of care)
e. Corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal
abrasion, inflammation or ulceration.
The Estimated Number of Participants
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Taiwan
10 participants
-
Global
90 participants
