NeoplasmsPhase 1NCT03788603
Rogaratinib (BAY1163877) in Chinese Patients
A Phase 1 study testing Rogaratinib (BAY1163877) in people with Neoplasms, run by Bayer at 1 site in China.
Trial summary
This study is planned to determine the safety and tolerability of rogaratinib in Chinese patients with fibroblast growth factor receptor (FGFR)-positive refractory, locally advanced, or metastatic solid tumors and to characterize the pharmacokinetics of rogaratinib in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Rogaratinib (BAY1163877)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2019to 14 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This study is planned to determine the safety and tolerability of rogaratinib in Chinese patients with fibroblast growth factor receptor (FGFR)-positive refractory, locally advanced, or metastatic solid tumors and to characterize the pharmacokinetics of rogaratinib in Chinese patients.
- Conditions
- Neoplasms
- Being tested
- Rogaratinib (BAY1163877)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rogaratinib (BAY1163877)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rogaratinib (BAY1163877) | Experimental | 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 Receives: Drug: Rogaratinib (BAY1163877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment-Emergent Adverse Events(TEAEs)
Measured: 30 days after last dose of rogaratinib
Severity of Treatment-Emergent Adverse Events(TEAEs)
Measured: 30 days after last dose of rogaratinib
Cmax: Maximum drug concentration in plasma after dose administration
Single dose
Measured: 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
Single dose
Measured: Cycle 1 Day 1 (each cycle is 21 days)
Cmax,md: Cmax after multiple dosing
Multiple dose
Measured: Cycle 1 Day 15 (each cycle is 21 days)
AUC(0-12)md: AUC(0-12) after multiple dosing
Multiple dose
Measured: Cycle 1 Day 15 (each cycle is 21 days)
Secondary outcomes (2)
Phosphate levels
Measured: Within 7-14 days after the last dose of rogaratinib
Response rate
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.
Measured: Within 7-14 days after the last dose of rogaratinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start7 Jan 2019
- Primary completion30 Apr 2019
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788603
- Sponsor's protocol ID
- 19177
- Status last verified
- Mar 2021
- First submitted
- 19 Dec 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03788603
- Acronym / sponsor ID
- 19177
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned to determine the safety and tolerability of rogaratinib in Chinese patients with fibroblast growth factor receptor (FGFR)-positive refractory, locally advanced, or metastatic solid tumors and to characterize the pharmacokinetics of rogaratinib in Chinese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rogaratinib (BAY1163877) | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rogaratinib (BAY1163877)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. | Drug | Rogaratinib (BAY1163877) |
Primary outcome
Frequency of Treatment-Emergent Adverse Events(TEAEs)
Time frame: 30 days after last dose of rogaratinib
Severity of Treatment-Emergent Adverse Events(TEAEs)
Time frame: 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
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
Cmax,md: Cmax after multiple dosing
Time frame: Cycle 1 Day 15 (each cycle is 21 days)
Multiple dose
AUC(0-12)md: AUC(0-12) after multiple dosing
Time frame: Cycle 1 Day 15 (each cycle is 21 days)
Multiple dose
2 secondary outcomes
Phosphate levels
Time frame: Within 7-14 days after the last dose of rogaratinib
Response rate
Time frame: Within 7-14 days after the last dose of rogaratinib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rogaratinib (BAY1163877) in people with Neoplasms, run by Bayer at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Treatment-Emergent Adverse Events(TEAEs) (time frame: 30 days after last dose of rogaratinib). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.