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Anti-metabolites

Surufatinib in combination with Gemcitabine for Soft Tissue Sarcomas

Phase 1 & 2

Waitlist Available

Led By Josephine Haduong

Research Sponsored by Hutchison Medipharma Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is testing the safety of a new cancer drug in children. It will help determine the best dose of the drug to give to children in the future.

Eligible Conditions

Non-rhabdomyosarcoma Soft Tissue Sarcomas
Osteosarcoma
Solid Tumors
Rhabdomyosarcoma
Ewing Sarcoma
Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of patients with Dose-Limiting Toxicity (DLT) at each dose level studied.

Part 1: Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0

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.

+3 more

Secondary outcome measures

To evaluate number of patients with treatment-emergent adverse events as assessed

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 - Dose expansionExperimental Treatment1 Intervention

Once the MTD/RP2D has been determined in the part 1 portion of the study, the part 2 disease specific cohorts for patients with refractory or recurrent osteosarcoma, Ewing Sarcoma, and RMS and non- RMS will open for enrollment.

Group II: Part 1- Dose escalationExperimental Treatment1 Intervention

Dose escalation study with sequential dose escalation of surufatinib in combination with gemcitabine. Patients with any recurrent or refractory solid tumors or lymphoma, who have a known or expected dysfunction of VEGFR-1, -2, and -3; FGFR-1; or CSF-1R pathways may be enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surufatinib in combination with Gemcitabine

2021

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hutchison Medipharma LimitedLead Sponsor

100 Previous Clinical Trials

13,536 Total Patients Enrolled

HutchmedLead Sponsor

29 Previous Clinical Trials

5,747 Total Patients Enrolled

Josephine HaduongPrincipal InvestigatorChildren's Hospital of Orange County

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the qualifications to become a participant in this trial?

"Eligible applicants to this clinical trial must have rhabdomyosarcoma and fall within the age bracket of 2-21. A total of 120 participants are being sought after for the study."

Answered by AI

What is the geographic reach of this trial?

"Participants can enrol in this clinical trial at several sites, including Washington University School of Medicine (St. Louis, Missouri), Riley Hospital for Children (Indianapolis, Indiana), and Johns Hopkins University (Baltimore, Maryland). Furthermore, there are 11 additional locations available."

Answered by AI

How many participants is this experiment recruiting?

"With the aim of conducting this experiment, Hutchison Medipharma Limited is seeking 120 patients that satisfy all inclusion criteria. The trial will be carried out at multiple sites including Washington University School of Medicine in Saint Louis and Riley Hospital for Children based in Indianapolis."

Answered by AI

Could you please describe the existing research on Surufatinib in combination with Gemcitabine?

"Currently, there are 467 clinical trials in progress for Surufatinib when administered together with Gemcitabine. Of those live studies, 137 have reached the Phase 3 level. All of these medical experiments originate from Woolloongabba, Queensland and they can be found at 24593 distinct sites worldwide."

Answered by AI

Is the age criterion for this experiment confined to individuals under 30?

"This clinical trial seeks out patients aged between 2 and 21 years old. Clinicialtrials.gov provides 558 trials for minors, while 2782 are available to the elderly population."

Answered by AI

To what diseases does the Surufatinib-Gemcitabine combination therapy prove efficacious?

"Surufatinib in combination with Gemcitabine can be a therapeutic option for individuals suffering from small cell lung cancer (SCLC), head and neck carcinoma, or advanced pancreatic adenocarcinoma."

Answered by AI

Are there new participants currently joining this investigation?

"Affirmative. The clinical trial entry hosted on clinicaltrials.gov indicates that the study is actively soliciting participants, which commenced recruitment after its 30th November 2021 posting and was most recently adjusted on 4th October 2022. Specifically, 120 volunteers are needed from 11 distinct medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors

2021. "A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093322.