OncologyPhase 1NCT02398513
Regorafenib Phase I Study in Mainland Chinese Patients
A Phase 1 study testing Regorafenib (Stivarga, BAY73-4506) in people with Oncology, run by Bayer at 1 site in China.
Trial summary
The primary objective of this study is to define the pharmacokinetic of Regorafenib administered orally as a single agent in Chinese patients with advance solid tumors. The second objective include the evaluation of safety, tolerability, and efficacy of Chinese patents treated with Regorafenib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Jun 2016
- 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
- Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and be willing to sign the written informed consent
- Patients with histologically or cytologically confirmed,refractory,locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom the specific clinical indications for which Regorafenib is approved elsewhere in the world is considered an appropriate treatment option.
- Male or female Chinese patients living in China mainland >= 18 years
- Patients must have measurable or non-measurable disease according to RECIST, version 1.1
- Eastern Cooperative Oncology Group performance status (ECOG-PS 0 - 1)
- Body mass index (BMI) between 18 and 33 kg/m2 inclusive
Show all 16Show fewer
- Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:
- Platelet count >= 100,000/cubic millimeters (mm3), hemoglobin (Hb) >= 9 g/dl, leukocyte count > 3,000/mm3, absolute neutrophil count (ANC) >=1,500/mm3. Transfusion to meet the inclusion criteria will not be allowed.
- Total bilirubin <= 1.5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 x ULN (<= 5 x ULN for patients with liver involvement of their cancer)
- Alkaline phosphatase limit <= 2.5 x ULN (<= 5 x ULN for patients whose cancer involves their liver and/or bone)
- Lipase <= 1.5 x ULN
- Serum creatinine <= 1.5 times ULN and estimated creatinine clearance (CLcr) >= 30 mL/min according to the Cockroft-Gault formula
- International normalized ratio (INR) <= 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) <= 1.5 x ULN. Patients being treated with anticoagulant, e.g. warfarin or heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.
- Life expectancy of at least 3 months.
- Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment.
Who cannot join
- Prior treatment with Regorafenib
- Patients unable to swallow and retain oral medications
- Any other malignant disease treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1)
- Symptomatic metastatic brain or meningeal tumors if the patient is < 6 months from definitive therapy, has evidence of tumor growth on an imaging study within 4 weeks prior to study entry and is on dexamethasone and not clinically stable with respect to the tumor at the time of study entry.
- Major surgical procedure, or significant traumatic injury within 28 days before start of study medication
- History of organ allograft
Show all 10Show fewer
- Non-healing wound, ulcer, or bone fracture
- Uncontrolled hypertension (systolic blood pressure >150 millimeter of mercury (mmHg) or diastolic blood pressure >90 mmHg despite optimal medical management)
- Persistent proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (>=Grade 3, NCI-CTCAE v 4.03).
- History of cardiac disease: congestive heart failure (CHF) >=NYHA (New York Heart Association) Class II. Active coronary artery disease unstable angina (angina symptoms at rest) or new-onset angina (within last 3 months) or myocardial infarction (MI) within past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncontrolled, Open-label, Non-randomized, Phase I Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Regorafenib in Chinese Patients (China Mainland) With Advanced, Refractory Solid Tumors)
The primary objective of this study is to define the pharmacokinetic of Regorafenib administered orally as a single agent in Chinese patients with advance solid tumors.
The second objective include the evaluation of safety, tolerability, and efficacy of Chinese patents treated with Regorafenib
- Conditions
- Oncology
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (Stivarga, BAY73-4506)Drug
Regorafenib 160 mg per oral
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Experimental | Patients enrolled in the study will start treatment with Regorafenib160 mg (given by four 40 mg tablets of Regorafenib) on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, Regorafenib 160 mg QD will be administered for 21 days, followed by 7 days off treatment. Treatment with Regorafenib will continue until the patient either progresses or meets one of the criteria for withdrawal prespecified in the study protocol. Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum drug concentration in plasma)
Measured: Cycle 0 day 1, 0、0.5、1、2、3、4、6、8、12、24、36、48、72、96 hours
AUC(0-24) (AUC from time 0 h to time 24 h post-administration)
Measured: Cycle 0 day1, 0、0.5、1、2、3、4、6、8、12、24 hours
AUC(0-tlast) (AUC from time zero to the last data point>LLOQ)
Measured: Cycle0 day 1, 0、0.5、1、2、3、4、6、8、12、24、36、48、72、96 hours
Cmax.ss (Cmax at steady-state during a dosage interval)
Measured: Cycle 1 day 21, 0,0.5,1,2,3,4,6,8,12,24,36,48,72,96 hours
AUCt.ss (AUC for the dosing interval at steady-state)
Measured: cycle 1 day 21 0,0.5,1,2,3,4,6,8,12,24 hours
Secondary outcomes (2)
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 30 days
Tumor Response base don RECIST 1.1 criteria
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398513
- Sponsor's protocol ID
- 15823
- Status last verified
- Jul 2016
- First submitted
- 20 Mar 2015
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled, Open-label, Non-randomized, Phase I Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Regorafenib in Chinese Patients (China Mainland) With Advanced, Refractory Solid Tumors)
- ClinicalTrials.gov ID
- NCT02398513
- Acronym / sponsor ID
- 15823
- Conditions
- Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Mar 2015 (estimated)
- 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.
The primary objective of this study is to define the pharmacokinetic of Regorafenib administered orally as a single agent in Chinese patients with advance solid tumors.
The second objective include the evaluation of safety, tolerability, and efficacy of Chinese patents treated with Regorafenib
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Experimental | Drug: Regorafenib (Stivarga, BAY73-4506)Patients enrolled in the study will start treatment with Regorafenib160 mg (given by four 40 mg tablets of Regorafenib) on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, Regorafenib 160 mg QD will be administered for 21 days, followed by 7 days off treatment. Treatment with Regorafenib will continue until the patient either progresses or meets one of the criteria for withdrawal prespecified in the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and be willing to sign the written informed consent
- Patients with histologically or cytologically confirmed,refractory,locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom the specific clinical indications for which Regorafenib is approved elsewhere in the world is considered an appropriate treatment option.
- Male or female Chinese patients living in China mainland >= 18 years
- Patients must have measurable or non-measurable disease according to RECIST, version 1.1
- Eastern Cooperative Oncology Group performance status (ECOG-PS 0 - 1)
Key exclusion criteria (10 listed)
- Prior treatment with Regorafenib
- Patients unable to swallow and retain oral medications
- Any other malignant disease treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1)
- Symptomatic metastatic brain or meningeal tumors if the patient is < 6 months from definitive therapy, has evidence of tumor growth on an imaging study within 4 weeks prior to study entry and is on dexamethasone and not clinically stable with respect to the tumor at the time of study entry.
- Major surgical procedure, or significant traumatic injury within 28 days before start of study medication
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 |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506)Regorafenib 160 mg per oral | Drug | Regorafenib (Stivarga, BAY73-4506) |
Primary outcome
Cmax (maximum drug concentration in plasma)
Time frame: Cycle 0 day 1, 0、0.5、1、2、3、4、6、8、12、24、36、48、72、96 hours
AUC(0-24) (AUC from time 0 h to time 24 h post-administration)
Time frame: Cycle 0 day1, 0、0.5、1、2、3、4、6、8、12、24 hours
AUC(0-tlast) (AUC from time zero to the last data point>LLOQ)
Time frame: Cycle0 day 1, 0、0.5、1、2、3、4、6、8、12、24、36、48、72、96 hours
Cmax.ss (Cmax at steady-state during a dosage interval)
Time frame: Cycle 1 day 21, 0,0.5,1,2,3,4,6,8,12,24,36,48,72,96 hours
AUCt.ss (AUC for the dosing interval at steady-state)
Time frame: cycle 1 day 21 0,0.5,1,2,3,4,6,8,12,24 hours
2 secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 30 days
Tumor Response base don RECIST 1.1 criteria
Time frame: Up to 30 days
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 1 Aug 2016.
Related trials for Oncology
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Bayer Study Director study director
Bayer
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 Regorafenib (Stivarga, BAY73-4506) in people with Oncology, 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 16 inclusion and 10 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 1 Aug 2016. 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?
Cmax (maximum drug concentration in plasma) (time frame: Cycle 0 day 1, 0、0.5、1、2、3、4、6、8、12、24、36、48、72、96 hours). The study lists 5 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 1 Aug 2016.