Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05691478 · ClinicalTrials.gov registry record · Phase 2
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
A Phase 2 study of Metastatic Osteosarcoma and High-grade Osteosarcoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 1,122
- Enrollment target
- 20
- Study locations
NCT05691478 is a Phase 2 study of Metastatic Osteosarcoma and High-grade Osteosarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 1,122 participants, above the 228-participant average among 8 other Metastatic Osteosarcoma trials with a reported enrollment target (392% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT05691478, a Phase 2 study of Metastatic Osteosarcoma and High-grade Osteosarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,122 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Bone Scan
- DRUG Cabozantinib S-malate
- DRUG Doxorubicin Hydrochloride
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,122 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2030-03-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05691478
The ClinicalTrials.gov registry entry for NCT05691478 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 1,122 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 228-participant average among 8 other Metastatic Osteosarcoma trials with a reported enrollment target (392% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Metastatic Osteosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT05691478 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05691478 about?
NCT05691478 is a clinical study titled "A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma". This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class...
What is the current status of trial NCT05691478?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,122 participants. The study started on 2023-03-03. Estimated completion is 2030-03-20.
What conditions does trial NCT05691478 study?
This clinical trial studies the following conditions: Metastatic Osteosarcoma, High-grade Osteosarcoma, Localized Osteosarcoma, Secondary Osteosarcoma.
What interventions are being tested in trial NCT05691478?
The interventions under investigation include: Computed Tomography (PROCEDURE), Cisplatin (DRUG), Bone Scan (PROCEDURE), Cabozantinib S-malate (DRUG), Doxorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05691478?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05691478 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Osteosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
RECRUITING · Phase 2
-
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
ACTIVE NOT RECRUITING · Phase 2
-
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
COMPLETED · Phase 2
-
Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma
COMPLETED · Phase 2
-
Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas
COMPLETED · Phase 2
-
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
RECRUITING · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.