A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

Conditions

• Refractory Solid Tumors

Eligibility Criteria

Sex

ALL

Age

1 Year - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Eribulin — DRUG
  Given by vein (IV)
• Irinotecan — DRUG
  Given by vein (IV)
• Temozolomide — DRUG
  Given by PO

Study Details

To find the recommended dose of eribulin that can be given in combination with irinotecan and temozolomide to treat relapsed and/or refractory solid tumors.

Key Dates

Start date

Aug 16, 2023

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2028

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Dose expansion-Ewings sarcoma
  The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase.
• Experimental: Arm B: Dose expansion -Rhabdomyosarcoma
  The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase.
• Experimental: Arm C: Dose expansion- other solid tumor histologies
  The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase.
• Experimental: Arm D: Dose finding levels 0,-1 and -2
  The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

Central Contacts

• Fiorela Hernandez Tejada, MD
  (832) 306-9802
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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