Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate (PALANGI3)

Centre Oscar Lambret

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Procedure: Blood sampling; Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 2); Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 1 ); Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 3)

Study type: Interventional

Funder types: Other

Identifiers

NCT01046487

PALANGI-3 0804

Details and patient eligibility

About

The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rare tumor
• metastatic disease or locally advanced disease, inoperable, with no standard treatment
• At least 28 days since the prior treatment
• Measurable disease with at least one measurable lesion

Exclusion criteria

• Medullary insufficiency
• Cystitis, haemorrhagic cystitis
• Hepatic porphyria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)