At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Surufatinib in combination with Gemcitabinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Surufatinib in combination with Gemcitabine for Solid Tumor and 5 related conditions. Completed, enrolled 13 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Lymphoma, Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartNov 2021
Primary CompletionApr 2023
TodayJul 2026
First PostedOct 26, 2021
Enrollment StartNov 30, 2021
Primary CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.7 years ago
Interventions
Surufatinib in combination with Gemcitabinedrug
Surufatinib in combination with Gemcitabine