Phase 2
N=13
A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
Solid Tumor · Lymphoma · Osteosarcoma · Ewing Sarcoma · Rhabdomyosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT05093322 ↗Enrolled (actual)
13
Serious AEs
61.5%
Results posted
May 2024
Primary outcome: Primary: Number of Patients With Dose-Limiting Toxicities (DLT) — 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Surufatinib in combination with Gemcitabine (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Hutchmed
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dose-Limiting Toxicities (DLT) |
0; 2 | — |
| PRIMARY Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity |
0; 0; 1; 1; 4; 2 | — |
| PRIMARY Number of Patients With Clinically Significant Physical Examination Abnormalities |
6; 1 | — |
| PRIMARY Number of Patients With Clinically Significant Vital Signs Abnormalities |
0; 0 | — |
| PRIMARY Number of Patients With Clinically Significant Laboratory Abnormalities |
0; 1 | — |
| PRIMARY Number of Patients With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities |
1; 0 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0 | — |
| SECONDARY Disease Control Rate (DCR) |
20.0; 0 | — |
| SECONDARY Time to Response (TTR) |
— | — |
| SECONDARY Duration of Response (DoR) |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
1.8; 1.5 | — |
| SECONDARY Number of Patients Who Performed Taste and Palatability Survey of Surufatinib |
0; 1; 0; 1; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age: At time of study enrollment, patients must be
For US Sites:
- Part 1 (including PK expansion cohort): ≥2 and 7 years) prior to any study-specific procedures, sampling, and analyses.
- Patient must meet all defined Inclusion criteria as defined in the current protocol.
Exclusion Criteria
- Patient must not meet any exclusion criteria as defined in the current protocol.
- Pregnant, breast feeding or planning on becoming pregnant.
- Patients is taking and prohibitive concomitant medications as outlined in the current protocol.
- Patients have an uncontrolled infection.
- Patients has had major surgery or significant traumatic injury within 28 days of the first dose.
- 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.
- History of allergies to Surufatinib and/or Gemcitabine.
Data sourced from ClinicalTrials.gov (NCT05093322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.