Self EfficacyPhase 2NCT02324803
Phase II Study of Pazopanib as Second-line Treatment After Sunitinib in mRCC Patients
A Phase 2 study testing pazopanib in people with Self Efficacy and Adverse Drug Event, run by Southern China Urology Cancer Consortium at 1 site in China.
Trial summary
assess the activity and toxicity of second-line treatment with pazopanib after failure of first-line sunitinib treatment in patients with clear cell mRCC; to investigate the potential association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical response to pazopanib in mRCC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Efficacy, Adverse Drug Event, Carcinoma, Renal Cell
- What is being tested?
- pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 2
- 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
- Written informed consent
- Diagnosis of renal cell carcinoma with clear-cell component histology.
- Locally advanced/metastatic renal cell carcinoma
- Measurable lesion (RECIST 1.1) on physical exam or as CT/MRI
- No prior systemic therapy for advanced/metastatic RCC
- Karnofsky performance scale >=70
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- Age >=18 years
- A female is eligible to enter and participate in this study if she is of: non-childbearing/agrees to use adequate contraception
- A male with female partner of childbearing potential must have vasectomy/agree to use effective contraception from two weeks prior to administration of the 1st dose of study treatment for a period of time after the last dose of study treatment
- Adequate organ function
- Able to swallow and retain orally administered medication and must not have clinically significant GIT abnormalities that may alter absorption
- The date of disease progression must be within six months of stopping sunitinib or during treatment with sunitinib
- Measurable lesion at pazopanib baseline as per the RECIST 1.1 criteria
Who cannot join
- Pregnant/lactating
- History of another malignancy (unless have been disease-free for 3 years)
- History or clinical evidence of Central nervous system metastases (unless have previously-treated CNS metastases and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 month time interval.
- Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess
- Moderate to severe hepatic impairment (Child-Pugh Class C)
- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
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- Subjects receiving chronic treatment with corticosteroids/other immunosuppressive agents
- Subjects with a known history of HIV seropositivity
- Subjects with active bleeding, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
- Presence of any severe or uncontrolled medical conditions/infection.
- Currently receiving chemotherapy, immunotherapy or radiotherapy
- Corrected QT interval (QTc) > 480 milliseconds
- History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
- Poorly controlled hypertension (defined as systolic blood pressure of >=140mmHg or diastolic blood pressure of >=90mmHg).
- History of cerebrovascular accident including transient ischemic attack, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless recent DVT have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
- Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding susceptibility.
- Known endobronchial lesion and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrage
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Mian Xie
About this study
Official title: Phase II Study of Pazopanib as Second-line Treatment After Sunitinib in Metastatic Renal Cell Carcinoma (mRCC) Patients
assess the activity and toxicity of second-line treatment with pazopanib after failure of first-line sunitinib treatment in patients with clear cell mRCC; to investigate the potential association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical response to pazopanib in mRCC patients.
Read the detailed description
The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR) and safety. We assessed the tumor response according to the RECIST 1.1.
Efficacy was evaluated by computed tomography with contrast of the chest, abdomen, and pelvis. We performed tumor assessments with the use of imaging studies at baseline and every six weeks until the end of treatment. We also used such assessments to confirm a response (at least 4 weeks after initial documentation) and whenever disease progression was suspected. All imaging scans were evaluated by an independent imaging-review committee (IRC) blinded to study treatment. Patients who had inadequate data for study assessment was regarded as nonevaluable.
Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Safety was assessed by physical examination and laboratory tests. Electrocardiograms (ECGs) were performed at baseline and every six weeks until the end of treatment.
- Conditions
- Self Efficacy, Adverse Drug Event, Carcinoma, Renal Cell
- Being tested
- pazopanib
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pazopanibDrug
Also called Votrient
continuous treatment of 800 mg pazopanib once daily until disease progression
| Study group | Role | What they receive |
|---|---|---|
| pazopanib once daily | Experimental | Patients received continuous treatment of 800 mg pazopanib once daily until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Dose reductions by 400 mg to a lowest dose of 200 mg daily were allowed on the basis of tolerability and according to protocol-defined guidelines. Receives: Drug: pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Measured: pazopanib treatment until earliest date of disease progression or death, assessed up to 30 months after the last patient has been enrolled
Secondary outcomes (3)
Overall survival of patients treated with second-line pazopanib therapy
Measured: Initiation of pazopanib dose until death, assessed up to 30 months after the last patient has been enrolled
Objective Response Rate to pazopanib therapy
Measured: Initiation of pazopanib treatment until time of confirmed best response, assessed up to 30 months after the last patient has been enrolled
Number of grade 3 or 4 adverse events attributable to pazopanib
Measured: Time of first dose of pazopanib to approximately one month after discontinuation of pazopanib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern China Urology Cancer Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mian Xie, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324803
- Sponsor's protocol ID
- SUCC001
- Status last verified
- Dec 2014
- First submitted
- 13 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pazopanib as Second-line Treatment After Sunitinib in Metastatic Renal Cell Carcinoma (mRCC) Patients
- ClinicalTrials.gov ID
- NCT02324803
- Acronym / sponsor ID
- SUCC001
- Conditions
- Self Efficacy, Adverse Drug Event, Carcinoma, Renal Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Southern China Urology Cancer ConsortiumUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Dec 2014 (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.
assess the activity and toxicity of second-line treatment with pazopanib after failure of first-line sunitinib treatment in patients with clear cell mRCC; to investigate the potential association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical response to pazopanib in mRCC patients.
Detailed description
The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR) and safety. We assessed the tumor response according to the RECIST 1.1.
Efficacy was evaluated by computed tomography with contrast of the chest, abdomen, and pelvis. We performed tumor assessments with the use of imaging studies at baseline and every six weeks until the end of treatment. We also used such assessments to confirm a response (at least 4 weeks after initial documentation) and whenever disease progression was suspected. All imaging scans were evaluated by an independent imaging-review committee (IRC) blinded to study treatment. Patients who had inadequate data for study assessment was regarded as nonevaluable.
Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Safety was assessed by physical examination and laboratory tests. Electrocardiograms (ECGs) were performed at baseline and every six weeks until the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pazopanib once daily | Experimental | Drug: pazopanibPatients received continuous treatment of 800 mg pazopanib once daily until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Dose reductions by 400 mg to a lowest dose of 200 mg daily were allowed on the basis of tolerability and according to protocol-defined guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent
- Diagnosis of renal cell carcinoma with clear-cell component histology.
- Locally advanced/metastatic renal cell carcinoma
- Measurable lesion (RECIST 1.1) on physical exam or as CT/MRI
- No prior systemic therapy for advanced/metastatic RCC
Key exclusion criteria (18 listed)
- Pregnant/lactating
- History of another malignancy (unless have been disease-free for 3 years)
- History or clinical evidence of Central nervous system metastases (unless have previously-treated CNS metastases and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 month time interval.
- Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess
- Moderate to severe hepatic impairment (Child-Pugh Class C)
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 |
|---|---|---|
| pazopanibAlso: Votrientcontinuous treatment of 800 mg pazopanib once daily until disease progression | Drug | pazopanib once daily |
Primary outcome
progression-free survival (PFS)
Time frame: pazopanib treatment until earliest date of disease progression or death, assessed up to 30 months after the last patient has been enrolled
3 secondary outcomes
Overall survival of patients treated with second-line pazopanib therapy
Time frame: Initiation of pazopanib dose until death, assessed up to 30 months after the last patient has been enrolled
Objective Response Rate to pazopanib therapy
Time frame: Initiation of pazopanib treatment until time of confirmed best response, assessed up to 30 months after the last patient has been enrolled
Number of grade 3 or 4 adverse events attributable to pazopanib
Time frame: Time of first dose of pazopanib to approximately one month after discontinuation of pazopanib
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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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.
Mian Xie principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pazopanib in people with Self Efficacy and Adverse Drug Event, run by Southern China Urology Cancer Consortium 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 13 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 24 Dec 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mian Xie (862083062956, mianxie@gird.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: pazopanib treatment until earliest date of disease progression or death, assessed up to 30 months after the last patient has been enrolled). 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 24 Dec 2014.