Kidney NeoplasmPhase 2NCT01961583
[18F]Fluciclatide PET Imaging of Pazopanib Response
A Phase 2 study testing 18F-Fluciclatide in people with Kidney Neoplasm, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional and metabolic responses of biological events with specific radiotracer in vivo. The PET tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD (arginine-glycine-aspartate) tri-peptide, which… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Neoplasm
- What is being tested?
- 18F-Fluciclatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Apr 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed renal cell carcinoma, stage IV patient.
- The tumor mass ≥1.5cm in diameter that is planned to receive Pazopanib as systemic antiangiogenic therapy.
- Pretreatment CT with or without contrast within 4 weeks prior to the first 18F-Fluciclatide PET scan.
- Evidence of unidimensionally measurable lesion(s) by RECIST criteria version 1.1.
- No prior systemic anti-angiogenic therapy for metastatic disease; prior antiangiogenic therapy used as an adjuvant therapy is allowed if it is completed 6 or more months before study enrollment.
- Male or female aged over 20 years
Show all 12Show fewer
- Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Have a life expectancy of at least 3 months.
- Adequate medical condition in the judgment of the investigator
- Be willing and able to comply with the protocol for the duration of the study.
- Be willing and able to implement effective contraceptive practice
- Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Who cannot join
- Received another IMP within 30 days before the first administration of 18F-Fluciclatide injection.
- Inability to perform 18F-Fluciclatide PET imaging studies due to physical inability or claustrophobia.
- Intra-hepatic tumor only (without extra-hepatic tumor)
- Chemotherapy within 2weeks, or received radiotherapy to the region of the target lesion, surgery of target lesion within 2 weeks prior to the first 18F-Fluciclatide PET scan
- Pregnant, nursing women or patients with reproductive potential without contraception.
- Current treatment on another therapeutic clinical trial(except Pazopanib study)
- Any patients with known allergy to the GE health care product or any or its excipients should be excluded from the study
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of [18F]FluciclatidePositron Emission Tomography For the Prediction of Response to Pazopanib In Patients With Metastatic Renal Cell Carcinoma: An Exploratory Study
Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional and metabolic responses of biological events with specific radiotracer in vivo. The PET tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and mature endothelial cells but are expressed at high levels on activated endothelial cells in the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib acts mainly on active angiogenetic tumors, the quantitative uptake of [18F]Fluciclatide can be used to predict the effect of this antiangiogenic drug. The investigators expected the baseline tumor uptake in [18F]Fluciclatide to be able to predict treatment response, and planned a study of [18F]FluciclatidePET for patients with metastatic RCC who received pazopanib systemic therapy.
Read the detailed description
Subjects will receive treatment with pazopanib at a dose of 800 mg orally once daily. [18F]Fluciclatide imagings will be taken 2 times; 1) before systemic therapy (at baseline), 2) at one week after starting of Pazopanib. However, If the target lesion on the baseline PET cannot be discriminated compared to the background activity, the 2nd PET will not be done. Response evaluation by CT will be performed at baseline, at 6 week, at 12 week and every 8 weeks thereafter until the end of treatment. RECIST1.1 criteria for response will be applied. Patient will be treated with Pazopanib until there is disease progression, unacceptable toxicity or withdrawal of patient consent.
- Conditions
- Kidney Neoplasm
- Being tested
- 18F-Fluciclatide
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FluciclatideDrug
Also called AH111585
Baseline 18F-Fluciclatide PET imaging will be obtained before starting of Pazopanib therapy(within 7 days).
Subsequent 18F-Fluciclatide PET should be performed on 7 days after Pazopanib therapy
| Study group | Role | What they receive |
|---|---|---|
| Drug; 18F-Fluciclatide | Experimental | 18F-Fluciclatide, 0.14 mCi/kg (not to exceed 10 mCi), IV(in the vein) administration Receives: Drug: 18F-Fluciclatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline 18F-Fluciclatide PET SUV
The difference of the baseline 18F-Fluciclatide PET SUV between responders and non-responders by RECIST criteria after Pazopanib therapy
Measured: Prior to starting Pazopanib treatment
Secondary outcomes (2)
The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria
Measured: 7±1 days after Pazopanib treatment
Progression free survival more than 6 month
Progression free survival defined as time from PET scan to the date of death, recurrence or progression
Measured: More than 6 month after 1st PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Termination of \[18F\]Fluciclatide production
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Jin-Sook Ryu, Asan Medical Center
- Investigators
- Jin-Sook Ryu, MD. PhD., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961583
- Sponsor's protocol ID
- 2013-0382
- Status last verified
- Feb 2016
- First submitted
- 7 Oct 2013
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F]FluciclatidePositron Emission Tomography For the Prediction of Response to Pazopanib In Patients With Metastatic Renal Cell Carcinoma: An Exploratory Study
- ClinicalTrials.gov ID
- NCT01961583
- Acronym / sponsor ID
- 2013-0382
- Conditions
- Kidney Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of \[18F\]Fluciclatide production
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Sep 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 11 Oct 2013 (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.
Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional and metabolic responses of biological events with specific radiotracer in vivo. The PET tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and mature endothelial cells but are expressed at high levels on activated endothelial cells in the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib acts mainly on active angiogenetic tumors, the quantitative uptake of [18F]Fluciclatide can be used to predict the effect of this antiangiogenic drug. The investigators expected the baseline tumor uptake in [18F]Fluciclatide to be able to predict treatment response, and planned a study of [18F]FluciclatidePET for patients with metastatic RCC who received pazopanib systemic therapy.
Detailed description
Subjects will receive treatment with pazopanib at a dose of 800 mg orally once daily. [18F]Fluciclatide imagings will be taken 2 times; 1) before systemic therapy (at baseline), 2) at one week after starting of Pazopanib. However, If the target lesion on the baseline PET cannot be discriminated compared to the background activity, the 2nd PET will not be done. Response evaluation by CT will be performed at baseline, at 6 week, at 12 week and every 8 weeks thereafter until the end of treatment. RECIST1.1 criteria for response will be applied. Patient will be treated with Pazopanib until there is disease progression, unacceptable toxicity or withdrawal of patient consent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug; 18F-Fluciclatide | Experimental | Drug: 18F-Fluciclatide18F-Fluciclatide, 0.14 mCi/kg (not to exceed 10 mCi), IV(in the vein) administration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed renal cell carcinoma, stage IV patient.
- The tumor mass ≥1.5cm in diameter that is planned to receive Pazopanib as systemic antiangiogenic therapy.
- Pretreatment CT with or without contrast within 4 weeks prior to the first 18F-Fluciclatide PET scan.
- Evidence of unidimensionally measurable lesion(s) by RECIST criteria version 1.1.
- No prior systemic anti-angiogenic therapy for metastatic disease; prior antiangiogenic therapy used as an adjuvant therapy is allowed if it is completed 6 or more months before study enrollment.
Key exclusion criteria (8 listed)
- Received another IMP within 30 days before the first administration of 18F-Fluciclatide injection.
- Inability to perform 18F-Fluciclatide PET imaging studies due to physical inability or claustrophobia.
- Intra-hepatic tumor only (without extra-hepatic tumor)
- Chemotherapy within 2weeks, or received radiotherapy to the region of the target lesion, surgery of target lesion within 2 weeks prior to the first 18F-Fluciclatide PET scan
- Pregnant, nursing women or patients with reproductive potential without contraception.
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 |
|---|---|---|
| 18F-FluciclatideAlso: AH111585Baseline 18F-Fluciclatide PET imaging will be obtained before starting of Pazopanib therapy(within 7 days). Subsequent 18F-Fluciclatide PET should be performed on 7 days after Pazopanib therapy | Drug | Drug; 18F-Fluciclatide |
Primary outcome
Baseline 18F-Fluciclatide PET SUV
Time frame: Prior to starting Pazopanib treatment
The difference of the baseline 18F-Fluciclatide PET SUV between responders and non-responders by RECIST criteria after Pazopanib therapy
2 secondary outcomes
The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria
Time frame: 7±1 days after Pazopanib treatment
Progression free survival more than 6 month
Time frame: More than 6 month after 1st PET scan
Results and safety
The study was stopped early (reason given: Termination of \[18F\]Fluciclatide production). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Cancer, Nuclear ScansLink provided by the sponsor.
- PazopanibLink provided by the sponsor.
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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.
Jin-Sook Ryu, MD. PhD. principal investigator
Asan Medical Center
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 18F-Fluciclatide in people with Kidney Neoplasm, run by Asan Medical Center at 1 site in South Korea.
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 12 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Mar 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 South Korea. 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?
The study was stopped early (reason given: Termination of \[18F\]Fluciclatide production). 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?
Baseline 18F-Fluciclatide PET SUV (time frame: Prior to starting Pazopanib treatment). 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 Mar 2016.