Lymphoma Clinical Trial
Official title:
An Open-Label, Multicenter Phase 1/2 Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
Verified date | February 2024 |
Source | Hutchmed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory solid tumors or lymphoma. The study will be conducted in 2 parts.
Status | Completed |
Enrollment | 13 |
Est. completion date | April 25, 2023 |
Est. primary completion date | April 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 21 Years |
Eligibility | Inclusion Criteria: 1. Age: At time of study enrollment, patients must be 1. Part 1 (including PK expansion cohort): =2 and =21 years of age; 2. Part 2: =2 and =21 years of age; 3. Patients with osteosarcoma can enroll up to <30 years old. 2. Diagnosis: 1. Part 1 - Patients with any recurrent or refractory solid tumors or lymphoma (not central nervous system [CNS]) that have a known or expected dysfunction of VEGFR 1, -2, and -3; FGFR-1, or CSF-1R pathways (based on literature) are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse. 2. Part 2 - Recurrent or refractory osteosarcoma (US and EU), Ewing sarcoma (US and EU), RMS (US and EU), or NRSTS (EU only). Patients must have had histologic verification of malignancy at original diagnosis or relapse. 3. Disease status: Patients must have measureable or evaluable disease for part 1 dose escalation; for part 2, patients must have measurable disease by RECIST version 1.1. 4. Therapeutic options: Patient's current disease state must be one for which there is no known curative therapy. 5. Performance level: Karnofsky =50 for patients =16 and <18 years of age and Lansky =50 for patients <16 years of age, Eastern Cooperative Oncology Group (ECOG) =2 for patients =18 years of age. 6. Adequate organ and bone marrow function as defined in the current protocol. 7. Adequate cardiac function as indicated as defined in the current protocol. 8. Patients with known bone marrow metastatic disease will be eligible for the study provided they meet the blood counts in the inclusion criteria as defined in the current protocol. 9. Adequate BP control which is defined as a BP <95th percentile (= grade 1) for age, height, and sex. 10. Informed consent: Provision of signed and dated written informed consent (parent/legal guardian if patient <18 years of age) and assent (from patients aged >7 years) prior to any study-specific procedures, sampling, and analyses. 11. Patient must meet all defined Inclusion criteria as defined in the current protocol. Exclusion Criteria: 1. Patient must not meet any exclusion criteria as defined in the current protocol. 2. Pregnant, breast feeding or planning on becoming pregnant. 3. Patients is taking and prohibitive concomitant medications as outlined in the current protocol. 4. Patients have an uncontrolled infection. 5. Patients has had major surgery or significant traumatic injury within 28 days of the first dose. 6. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy and without clinical imaging evidence of SD for 14 days or longer. 7. History of allergies to Surufatinib and/or Gemcitabine. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | The University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | Childrens Hospital Orange County | Orange | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Children's National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Hutchmed |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1: Number of patients with Dose-Limiting Toxicity (DLT) at each dose level studied. | To determine maximum tolerated dose of surufatinib in combination with gemcitabine | up to 90 days | |
Primary | Part 1: Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0 | To determine the safety and tolerability of surufatinib in combinations with gemcitabine | up to 4 years | |
Primary | Part 2: To study the rate of patients who have achieved Complete Response (CR) or Partial Response (PR) in pediatric patients with Ewing sarcoma, Rhabdomyosarcoma (RMS), or Non-RMS (NRSTS) treated with the combination of surufatinib and gemcitabine. | The rate of patients who have achieved CR or PR will be reported. | up to 4 years | |
Primary | Part 2: To study the Time to Response (TTR) of the combination of surufatinib and gemcitabine in pediatric patients with Ewing sarcoma, RMS, or NRSTS. | The time to CR or PR will be reported. | up to 4 years | |
Primary | Part 2: To study the duration of response (DoR) of the combination of surufatinib and gemcitabine in pediatric patients with Ewing sarcoma, RMS, or NRSTS. | The duration of CR or PR will be reported. | up to 4 years | |
Primary | Part 2: To study the progression-free survival (PFS) of the combination of surufatinib and gemcitabine in pediatric patients with Ewing sarcoma, RMS, or NRSTS. | The time from enrollment in the clinical trial to disease progression or death will be reported. | up to 4 years | |
Secondary | To evaluate number of patients with treatment-emergent adverse events as assessed | To evaluate the safety in the pediatric patient population when treated with the combination of surufatinib and gemcitabine | up to 4 years |
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