Clear Cell Renal Cell CarcinomaPhase 2SuAxNCT03592199
Biomarker Study of Pts With Metastatic ccRCC Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib
A Phase 2 study testing Sunitinib in people with Clear Cell Renal Cell Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
This is a prospective single arm phase II study to evaluate potential prognostic and/or predictive biomarkers in patients with metastatic ccRCC undergoing treatment with 1st line sunitinib on a 4/2 schedule followed by axitinib on 2nd line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Dec 2017to 11 Dec 2022
- 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
- Diagnosis of Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint Committee on Cancer staging) renal cell carcinoma;
- Histologic confirmed clear cell renal cell carcinoma;
- No prior systemic therapy (interleukin-2, interferon-α, chemotherapy, bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, everolimus or temsirolimus) for advanced or metastatic RCC;
- Measurable disease by RECIST;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2;
- Adequate organ system functions;
- Patients must understand and be willing to sign the written informed consent form of this study.
Who cannot join
- Non-clear cell renal cell carcinoma
- Pregnant or lactating female.
- History of another malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin carcinoma or successfully treated in situ carcinoma are eligible.
- History or clinical evidence of central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery) and meet all 3 of the following criteria are eligible:
- Are asymptomatic
- No evidence of active CNS metastases for ≥3 months prior to enrolment
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- Have no requirement for steroids or anticonvulsants
- 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
- Inflammatory bowel disease
- Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 28 days prior to beginning study treatment.
- History of any one or more of the following cardiovascular conditions within the past 12 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- History of cerebrovascular accident including transient ischemic attack (TIA).
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥150 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) of ≥ 90 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Study of Patients With Metastatic Clear Cell Renal Carcinoma (ccRCC) Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib
This is a prospective single arm phase II study to evaluate potential prognostic and/or predictive biomarkers in patients with metastatic ccRCC undergoing treatment with 1st line sunitinib on a 4/2 schedule followed by axitinib on 2nd line therapy.
Read the detailed description
In this study, all included patients will receive sunitinib until disease progression and/or limiting toxicity. If patients develop toxicities ≥ Grade 2 on 50 mg per day 4 weeks-on / 2 weeks-off schedule, a modified schedule of 50 mg/day 2 weeks-on / 1 week-off will be offered. After disease progression on sunitinib, all eligible patients will receive axitinib 5 mg twice a day. The investigators plan to assess, by next generation sequencing, the prevalence of mutations in several cancer related genes in baseline archived tissue from the patients included in the study, and the potential correlations between these somatic mutations and anti-VEGF (Vascular Endothelial Growth Factor) therapy efficacy.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- Sunitinib
- Keywords
- biomarker, metastatic, sunitinib, axitinib, next generation sequencing, clear cell renal cell carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Axitinib
1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy
| Study group | Role | What they receive |
|---|---|---|
| 1st Line Sunitinib and 2nd Line Axitinib | Experimental | 1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st line Response Rate (RR) with Sunitinib in patients with VEGF pathway mutation
First Line Response Rate (RR) With Sunitinib (RECIST 1.1) in patients with VEGF pathway mutation
Measured: through study completion (up to 2 years)
Secondary outcomes (6)
1sr line RR with Sunitinib
First Line Response Rate (RR) with Sunitinib (RECIST 1.1)
Measured: through study completion (up to 2 years)
2nd Line RR with Axitinib
Second Line Response Rate (RR) with Axitinib (RECIST 1.1)
Measured: through study completion (up to 2 years)
1st line PFS with Sunitinib
First Line Progression Free Survival (PFS) with Sunitinib
Measured: through study completion (up to 2 years)
2nd PFS with Axitinib
Second Line Progression Free Survival (PFS) with Axitinib
Measured: through study completion (up to 2 years)
Overall Survival (OS)
Overall Survival
Measured: through study completion (up to 2 years)
Incidence of Treatment-Emergent Adverse Events
CTCAE v.4.0
Measured: through study completion (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start11 Dec 2017
- Primary completion11 Dec 2019 (estimated)
- Study completion11 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592199
- Sponsor's protocol ID
- NP 1096/17
- Acronym
- SuAx
- Status last verified
- Sep 2019
- First submitted
- 27 Dec 2017
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Study of Patients With Metastatic Clear Cell Renal Carcinoma (ccRCC) Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib
- ClinicalTrials.gov ID
- NCT03592199
- Acronym / sponsor ID
- SuAx / NP 1096/17
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- biomarker, metastatic, sunitinib, axitinib, next generation sequencing, clear cell renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 11 Dec 2019 (estimated)
- Study completion
- 11 Dec 2022 (estimated)
- First posted
- 19 Jul 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 is a prospective single arm phase II study to evaluate potential prognostic and/or predictive biomarkers in patients with metastatic ccRCC undergoing treatment with 1st line sunitinib on a 4/2 schedule followed by axitinib on 2nd line therapy.
Detailed description
In this study, all included patients will receive sunitinib until disease progression and/or limiting toxicity. If patients develop toxicities ≥ Grade 2 on 50 mg per day 4 weeks-on / 2 weeks-off schedule, a modified schedule of 50 mg/day 2 weeks-on / 1 week-off will be offered. After disease progression on sunitinib, all eligible patients will receive axitinib 5 mg twice a day. The investigators plan to assess, by next generation sequencing, the prevalence of mutations in several cancer related genes in baseline archived tissue from the patients included in the study, and the potential correlations between these somatic mutations and anti-VEGF (Vascular Endothelial Growth Factor) therapy efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1st Line Sunitinib and 2nd Line Axitinib | Experimental | Drug: Sunitinib1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint Committee on Cancer staging) renal cell carcinoma;
- Histologic confirmed clear cell renal cell carcinoma;
- No prior systemic therapy (interleukin-2, interferon-α, chemotherapy, bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, everolimus or temsirolimus) for advanced or metastatic RCC;
- Measurable disease by RECIST;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2;
Key exclusion criteria (22 listed)
- Non-clear cell renal cell carcinoma
- Pregnant or lactating female.
- History of another malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin carcinoma or successfully treated in situ carcinoma are eligible.
- History or clinical evidence of central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery) and meet all 3 of the following criteria are eligible:
- Clinically significant gastrointestinal abnormalities including, but not limited to:
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 |
|---|---|---|
| SunitinibAlso: Axitinib1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy | Drug | 1st Line Sunitinib and 2nd Line Axitinib |
Primary outcome
1st line Response Rate (RR) with Sunitinib in patients with VEGF pathway mutation
Time frame: through study completion (up to 2 years)
First Line Response Rate (RR) With Sunitinib (RECIST 1.1) in patients with VEGF pathway mutation
6 secondary outcomes
1sr line RR with Sunitinib
Time frame: through study completion (up to 2 years)
2nd Line RR with Axitinib
Time frame: through study completion (up to 2 years)
1st line PFS with Sunitinib
Time frame: through study completion (up to 2 years)
2nd PFS with Axitinib
Time frame: through study completion (up to 2 years)
Overall Survival (OS)
Time frame: through study completion (up to 2 years)
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion (up to 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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 2 study testing Sunitinib in people with Clear Cell Renal Cell Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 7 inclusion and 22 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 4 Sep 2019. 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 Brazil. 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?
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?
1st line Response Rate (RR) with Sunitinib in patients with VEGF pathway mutation (time frame: through study completion (up to 2 years)). 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 4 Sep 2019.