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Cabozantinib With Topotecan-Cyclophosphamide

NCT04661852 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-15

No results posted yet for this study

Summary

This research study is a clinical trial of a new combination of drugs as a possible treatment for relapsed/refractory Ewing sarcoma and/or osteosarcoma.

* The names of the drugs are:

* Cabozantinib
* Topotecan
* Cyclophosphamide
* The names of the non-investigational supportive care drugs are:

* Filgrastim, pegfilgrastim, or a related growth factor.

Conditions

  • Relapsed Ewing Sarcoma
  • Refractory Ewing Sarcoma
  • Relapsed Osteosarcoma
  • Refractory Osteosarcoma

Interventions

DRUG

Cabozantinib

PO (dose and schedule based upon dose level and nomogram)

DRUG

Topotecan

IV, over 30 minutes (schedule based upon dose level)

DRUG

Cyclophosphamide

IV, over 30 minutes (schedule based upon dose level)

DRUG

Myeloid growth factor

subcutaneous filgrastim (daily until ANC ≥ 1,500/mm3 after nadir) or pegfilgrastim (once) must be given, with choice of agent per institutional standard or treating physician preference, starting on day 5, 6, 7 or 8 (depending upon chemotherapy timing)

Sponsors & Collaborators

Principal Investigators

  • Steven C DuBois, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2022-10-24
Completion
2022-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04661852 on ClinicalTrials.gov