BridgeMD
New treatment option for Soft Tissue Sarcomas
Official title A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas
ClinicalTrials.gov ID: NCT07444619
What this study is testing
What is Pazopanib?
Pazopanib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for soft tissue sarcomas.
Also referred to as Votrient.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to build on the experience of the SAINT trial by evaluating the safety and efficacy of the addition of pazopanib to their published chemotherapy regimen.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join if
- All Recurrent STS are eligible for enrollment. All laboratory studies will need to be complete within 7 days prior to initiating protocol therapy...
- Age: Patients must be \> 1 year of age and . 30 years of age at time of initiation of protocol therapy.
- Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory STS.
- Disease Status: Patients must have evaluable disease. a. Patients may have CNS metastases at study entry, if they are previously treated or stable...
- Performance Level: Karnofsky . 50% for patients \> 16 years old, and Lansky . 50 for patients 1-16 years old. (See Appendix I)
You likely can't join if
- Significant organ dysfunction, not meeting inclusion criteria.
- Pediatric people who are considered wards of some entity.
- Pregnancy or Breast-Feeding Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events...
- Concomitant Medications:
- Growth factor: Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days.
- Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to section 4.1, Prior Therapy)
See the full eligibility criteria
- All Recurrent STS are eligible for enrollment. All laboratory studies will need to be complete within 7 days prior to initiating protocol therapy. All imaging studies will need to be done within 28 days prior to...
- Age: Patients must be \> 1 year of age and . 30 years of age at time of initiation of protocol therapy.
- Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory STS.
- Disease Status: Patients must have evaluable disease. a. Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initiation or the need for increased steroids...
- Performance Level: Karnofsky . 50% for patients \> 16 years old, and Lansky . 50 for patients 1-16 years old. (See Appendix I)
- Prior Therapy: Patients may have received prior therapy including single-agent pazopanib or trabectedin. Patients may not have previously been treated with combination therapy of pazopanib and trabectedin. a. Patients...
- Organ Function Requirements a. Bone Marrow Function: i. Peripheral absolute neutrophil count (ANC) . 750/ƒÊL ii. Platelet count . 75,000/ƒÊL (no platelet transfusion within 7 days prior to obtaining laboratory result)...
- Significant organ dysfunction, not meeting inclusion criteria.
- Pediatric people who are considered wards of some entity.
- Pregnancy or Breast-Feeding Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
- Concomitant Medications:
- Growth factor: Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days.
- Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to section 4.1, Prior Therapy)
- Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to section 4.1, Prior Therapy)
- Medication Allergy: i. Allergy or intolerance to agents on this protocol: Trabectedin. Pazopanib, Ipilimumab or Nivolumab e. Infection: Patients who have uncontrolled infection, positive blood cultures within the past...
- Known history of human immunodeficiency virus (HIV) infection
- Known active infection of hepatitis B or Hepatitis C virus
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.