- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03788603
Rogaratinib (BAY1163877) in Chinese Patients
An Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Rogaratinib (BAY1163877) in Chinese Patients With FGFR-positive Refractory, Locally Advanced, or Metastatic Solid Tumors
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100730
- Beijing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients ≥18 years of age on the date of signing the Main Informed Consent Form.
- Subjects with histologically or cytologically confirmed, refractory, locally advanced, or metastatic solid tumors who are not candidates for any standard therapy, excluding primary brain or spinal tumors.
- High FGFR1, 2, 3 or 4 mRNA expression levels based on archival or fresh tumor biopsy specimen analysis (RNAscope score of 3 or 4)
- At least one measurable lesion outside the central nervous system according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) A lesion in a previously irradiated area is eligible and to be considered measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment. Patients with resected primary tumors who have documented metastases are eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
- Life expectancy of at least 3 months
Adequate bone marrow, liver and renal function as assessed by laboratory requirements conducted within 7 days before the first dose of rogaratinib:
- Hemoglobin (Hb) ≥9.0 g/dL (without transfusion or erythropoietin within 4 weeks before screening)
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelet count ≥100,000/mm3
- Total bilirubin ≤1.5 times the upper limit of normal (ULN). Documented or diagnosed constitutional jaundice such as Gilbert syndrome is allowed if total bilirubin is mildly elevated (<6 mg/dL).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN (≤5 times ULN for patients with liver involvement of their cancer)
- Alkaline phosphatase ≤2.5 times ULN (≤5 times ULN for patients with liver involvement of their cancer)
- Amylase and lipase ≤2.5 times ULN
- Serum creatinine ≤1.5 x ULN and glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2, according to the Modified Diet in Renal Disease (MDRD) abbreviated formula
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study.
The following previous or concurrent cancer types might be acceptable: cervical carcinoma in situ, treated basal cell carcinoma, locally confined prostate cancer, or any cancer curatively treated >3 years before the start of rogaratinib.
- Symptomatic brain or meningeal or spinal metastases.
Asymptomatic brain or meningeal or spinal metastases are acceptable if all of the following criteria are met:
- Definitive therapy completed >6 months before the start of rogaratinib
- No evidence of the growth of brain or meningeal or spinal metastases on an imaging test performed within 4 weeks before the start of rogaratinib
Clinically and radiologically stable with respect to the tumor at the time of study entry
- Moderate or severe liver cirrhosis (Child-Pugh class B or C)
- History or current evidence of altered endocrine regulation of calcium phosphate homeostasis (e.g. parathyroidectomy, parathyroid disorder, tumor lysis, tumoral calcinosis)
- Any previous drug / procedure-related toxicity (patients with persistent alopecia, anemia, and / or hypothyroidism can be included) not recovered to National Cancer Institute's Common Terminology Criteria for Adverse Event, version 4.03 (CTCAE v4.03) Grade 0 or 1 or not recovered to baseline preceding the prior treatment
- Current diagnosis of any retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion.
- Previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Rogaratinib (BAY1163877)
Eligible patients will be selected based on the confirmation of high fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 mRNA expression levels in archival or fresh tumor biopsy specimens collected before the start of screening
|
Rogaratinib will be administered on 20 days in Cycle 1 (single dosing on Day 1 and twice daily dosing on Days 3-21).
In Cycles ≥2, rogaratinib will be administered twice daily for 21 days, with cycles repeated every 21 days.
Treatment will be continued until death, tumor progression, unacceptable toxicity, consent withdrawal, or until another criterion is met for withdrawal from the study at the discretion of the investigator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Treatment-Emergent Adverse Events(TEAEs)
Time Frame: 30 days after last dose of rogaratinib
|
30 days after last dose of rogaratinib
|
|
Severity of Treatment-Emergent Adverse Events(TEAEs)
Time Frame: 30 days after last dose of rogaratinib
|
30 days after last dose of rogaratinib
|
|
Cmax: Maximum drug concentration in plasma after dose administration
Time Frame: Cycle 1 Day 1 (each cycle is 21 days)
|
Single dose
|
Cycle 1 Day 1 (each cycle is 21 days)
|
AUC(0-12): AUC from time zero to 12 hours p.a. after first-dose administration
Time Frame: Cycle 1 Day 1 (each cycle is 21 days)
|
Single dose
|
Cycle 1 Day 1 (each cycle is 21 days)
|
Cmax,md: Cmax after multiple dosing
Time Frame: Cycle 1 Day 15 (each cycle is 21 days)
|
Multiple dose
|
Cycle 1 Day 15 (each cycle is 21 days)
|
AUC(0-12)md: AUC(0-12) after multiple dosing
Time Frame: Cycle 1 Day 15 (each cycle is 21 days)
|
Multiple dose
|
Cycle 1 Day 15 (each cycle is 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phosphate levels
Time Frame: Within 7-14 days after the last dose of rogaratinib
|
Within 7-14 days after the last dose of rogaratinib
|
|
Response rate
Time Frame: Within 7-14 days after the last dose of rogaratinib
|
Response rate is defined as the proportion of patients who have a best overall response rating of complete response (CR) and partial response (PR) that is achieved during treatment.
|
Within 7-14 days after the last dose of rogaratinib
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
GlaxoSmithKlineCompleted
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedUterine Cervical Neoplasms | Prostatic Neoplasms | Rectal Neoplasms | Endometrial Neoplasms | Anus NeoplasmsUnited States
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
GlaxoSmithKlineRecruitingColonic Neoplasms | Neoplasms, ColonUnited States, Finland, France, Italy, Japan, Netherlands, Norway, Spain, Taiwan, United Kingdom, Australia, Belgium, Brazil, Germany, Greece, Sweden, Turkey, Canada, Korea, Republic of, Argentina, Hungary, Estonia, Portugal, Mexico, Pa...
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong
Clinical Trials on Rogaratinib (BAY1163877)
-
BayerCompletedNeoplasmsFrance, United States, Spain, Singapore, Germany, Korea, Republic of, Switzerland
-
BayerCompletedCarcinoma, Transitional CellUnited States, Spain, Hungary, China, Belgium, Korea, Republic of, Taiwan, Australia, Singapore, Canada, Japan, Sweden, Russian Federation, Germany, Italy, Israel, Ireland, France, Austria, Denmark, Portugal, Switzerland, Czechia, Slo... and more
-
BayerCompletedPharmacokinetics | Clinical Trial, Phase INetherlands
-
BayerCompletedAdvanced or Metastatic Solid TumorUnited States, Spain, Korea, Republic of, Belgium, Singapore, Germany
-
BayerCompleted
-
BayerActive, not recruitingUrothelial CarcinomaUnited States, Korea, Republic of, Japan, Germany, Italy, Spain, Austria, France
-
Dana-Farber Cancer InstituteBayerWithdrawn
-
Swiss Group for Clinical Cancer ResearchTerminatedSquamous-cell Non-small Cell Lung CancerSwitzerland
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Gastrointestinal Stromal Tumor | Metastatic Sarcoma | Locally Advanced Sarcoma | Locally Advanced Gastrointestinal Stromal Tumor | Stage III Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8 | Stage III Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal... and other conditionsUnited States