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

C

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)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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