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

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byJosephine Haduong

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hutchison Medipharma Limited

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

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.

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.

Patient must meet all defined Inclusion criteria as defined in the current protocol.

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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.

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Treatment Details

Interventions

Gemcitabine (Anti-metabolites)
Surufatinib (Tyrosine Kinase Inhibitor)

Participant Groups

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 NRSTS 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.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: