Relapsed Pediatric Solid TumorPhase 1/2NCT03628131
Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
A Phase 1/2 study testing Pazopanib, Ifosfamide and Carboplatin in people with Relapsed Pediatric Solid Tumor and Refractory Pediatric Solid Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor Read more about this study
- Who is it for?
- Ages 2 to 22 years
- Conditions the study is for
- Relapsed Pediatric Solid Tumor, Refractory Pediatric Solid Tumor
- What is being tested?
- Pazopanib, Ifosfamide and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2018to Jul 2025
- Phase
- Phase 1/2
- 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 2 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse)
- Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)"
Who cannot join
- Patients who had high-dose chemotherapy and autologous stem cell transplantation previously
- Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction <40%, significant arrhythmia or conduction disturbance)
- Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
- Patients with active bleeding
- Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents
- Pregnant or nursing women
- Patients who can not swallow the pill
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul
Ki Woong Sung, 82-2-3410-3529, kwsped@skku.edu
Ki Woong Sung
About this study
Official title: Safety and Efficacy of Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor
- Being tested
- Pazopanib, Ifosfamide, Carboplatin, Etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
IfosfamideDrug
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
CarboplatinDrug
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
EtoposideDrug
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib + conventional chemotherapy | Experimental | Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib Receives: Drug: Pazopanib; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
Definition of dose-limiting toxicity (DLT)
- Hematologic DLT: delayed recovery of ANC/platelets > 42 days
- Grade 3 creatinine elevation, proteinuria, hyperbilirubinemia, bleeding
- Grade 2 arterial thrombosis
- Any grade 4 toxicities except hematologic toxicities
Measured: 42 days
Secondary outcomes (3)
Rate of tumor response (neuroblastoma)
- as assessed by International Neuroblastoma Response
- Primary tumor: CT and/or MRI; MIBG scan if available
- Metastatic sites: bone marrow biopsies, CT/MRI, MIBG scan
- CR (Complete response): No tumor (primary \& metastatic)
- VGPR (Very good PR): Decreased by 90-99% (primary) \& no tumor (metastatic)
- PR (Partial response): Decreased by > 50% (primary \& metastatic)
- MR (Mixed response): > 50% reduction of any measurable lesion (primary or metastases) with < 50% reduction in any other; < 25% increase in any existing lesion
- SD (Stable disease): No new lesions; < 50% reduction but < 25% increase in any existing lesion.
- PD (Progressive disease): Any new lesion; increase of any measurable lesion by > 25%
Measured: 4 weeks
Rate of tumor response (brain tumor)
- as assessed by 2-dimensional measurement (the product of the tumor's longest diameter and its longest perpendicular diameter)
- CR: complete disappearance of all previously measurable tumors.
- PR: greater than 50% decrease in tumor size
- SD: less than 50% reduction in tumor size or less than 25% increase in tumor size
- PD: greater than 25% increase in tumor size or the appearance of a new tumor
Measured: 4 weeks
Rate of tumor response (other solid tumors)
- as assessed by The Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- CR: Disappearance of all target lesions.
- PR: At least a 30% decrease in the sum of diameters of target lesions
- SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
- PD: At least a 20% increase in the sum of diameters of target lesions
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Pediatric Solid TumorStudies of the same condition, open and under way.
- More trials run by Samsung 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Sponsor
- Investigators
- Ki Woong Sung, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628131
- Sponsor's protocol ID
- 2017-11-147
- Status last verified
- Sep 2018
- First submitted
- 23 Jul 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT03628131
- Acronym / sponsor ID
- 2017-11-147
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 14 Aug 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.
The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib + conventional chemotherapy | Experimental | Drug: Pazopanib, Drug: Ifosfamide, Drug: Carboplatin, Drug: EtoposideConventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib |
Who may qualify
- Ages
- 2 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse)
- Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)"
Key exclusion criteria (7 listed)
- Patients who had high-dose chemotherapy and autologous stem cell transplantation previously
- Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction <40%, significant arrhythmia or conduction disturbance)
- Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
- Patients with active bleeding
- Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents
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 |
|---|---|---|
| PazopanibConventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib | Drug | Pazopanib + conventional chemotherapy |
| IfosfamideConventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib | Drug | Pazopanib + conventional chemotherapy |
| CarboplatinConventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib | Drug | Pazopanib + conventional chemotherapy |
| EtoposideConventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib | Drug | Pazopanib + conventional chemotherapy |
Primary outcome
Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
Time frame: 42 days
Definition of dose-limiting toxicity (DLT) * Hematologic DLT: delayed recovery of ANC/platelets > 42 days * Grade 3 creatinine elevation, proteinuria, hyperbilirubinemia, bleeding * Grade 2 arterial thrombosis * Any grade 4 toxicities except hematologic toxicities
3 secondary outcomes
Rate of tumor response (neuroblastoma)
Time frame: 4 weeks
Rate of tumor response (brain tumor)
Time frame: 4 weeks
Rate of tumor response (other solid tumors)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
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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.
Ki Woong Sung, MD, PhD principal investigator
Samsung 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 1/2 study testing Pazopanib, Ifosfamide and Carboplatin in people with Relapsed Pediatric Solid Tumor and Refractory Pediatric Solid Tumor, run by Samsung 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 2 inclusion and 7 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 19 Sep 2018. 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 combined 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.
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 Ki Woong Sung, MD, PhD (82-2-3410-3529, kiwoong.sung@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy (time frame: 42 days). 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 19 Sep 2018.