A study investigating the pharmcokintetics (how the body processes with a drug) and pharmcodynamics (what effect the drug has on the body) of the chemotherapy drug doxorubicin, when used to treat children, adolescents and young adults with newly diagnosed cancers: osteosarcoma, Ewing's family of tumours, and Hodgkin lymphoma.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Ewing family of tumoursOsteosarcomaHodgkin lymphoma; MedDRA version: 14.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10015570Term: Ewing's tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10031291Term: OsteosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-005554-62-GB
• Lead Sponsor: Australian Sarcoma Group (ASSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-21
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

- Newly diagnosed with osteosarcoma, Ewing family of tumours or Hodgkin lymphoma
- =1 year and 40years of age (in the UK only patients aged 11 - 40 years will be recruited)
- Planned treatment involves standard of care doxorubicin-containing regimens.
- Written informed consent from patient and/or patient’s parent or legal guardian.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Impaired hepatic function such as known chronic liver disease, evidence of impaired synthetic function or transaminases raised >5 x normal

- Significant uncontrolled systemic illness as judged by investigator

- Females who are pregnant or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified