Trials / Completed
CompletedNCT01518413
Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Solid Tumors
Phase 1 Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Relapsed or Refractory Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- HMeany · Academic / Other
- Sex
- All
- Age
- 2 Years – 22 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safest and most effective oral dose combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e. relapsed or refractory.
Detailed description
Sorafenib, a multi-kinase inhibitor of several targets felt to be important in tumor growth and angiogenesis, has been well studied and shown promising clinical results in adult cancer patients and the Maximum Tolerated Dose or MTD has been determined in pediatric patients. Irinotecan is known to be effective and is widely used in pediatric malignancies. The combination of sorafenib with irinotecan is of interest as these agents have different mechanisms of action. In addition, the combination has been evaluated in adult patients and deemed tolerable without alterations in the pharmacokinetic (PK) profile at the MTD. The trial we are proposing also offers the advantage of being a completely oral regimen, adding convenience and cost effectiveness. Given these considerations, if the sorafenib/irinotecan combination proves tolerable in phase I studies and shows efficacy in phase II studies, it would be an attractive combination to incorporate into existing chemotherapy regimens for pediatric cancer.
Conditions
- Rhabdomyosarcoma and Other Soft Tissue Sarcomas
- Ewing's Sarcoma Family of Tumors
- Osteosarcoma
- Neuroblastoma
- Brain Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sorafenib | sorafenib (50 and 200 mg tablets) orally twice daily, on a continuous schedule at a starting dose of 150mg/m2/dose. |
| DRUG | irinotecan | irinotecan (70 mg/m2/dose) orally, concurrently, once daily,starting at the beginning of the 21 day cycle,repeated every 21 days |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2012-01-26
- Last updated
- 2015-02-27
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01518413. Inclusion in this directory is not an endorsement.