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Completed

NCT Number: NCT01046487

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

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).

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Key information

Conditions

Cancer Adenocarcinoma Carcinoma Carcinoma, Adenoid Cystic Chordoma Dermatofibrosarcoma Desmoid Tumors Digestive System Diseases Digestive System Neoplasms Eye Diseases Eye Neoplasms Fibroma Fibrosarcoma Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Sarcoma Uveal Diseases Uveal Melanoma Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut Bergonié, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imatinib mesylate, Cyclophosphamide (Dosing level 1 )

Drug

CYCLE 1 (42 days):

  • Day 1 to 14 Imatinib mesylate : 400 mg/day, per os
  • Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

Imatinib mesylate, Cyclophosphamide (Dosing level 2)

Drug

CYCLE 1 (42 days):

  • Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os
  • Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os

Imatinib mesylate, Cyclophosphamide (Dosing level 3)

Drug

CYCLE 1 (42 days):

  • Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os
  • Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os

blood sampling

Procedure

ONLY FOR CYCLE 1, at day 15 and day 28 :

11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)

Primary outcomes

  1. For safety: NCI-CTCAE scale version 3.0

    Time frame: 42 days

Secondary outcomes

  1. For anti tumoral efficiency : RECIST criteria

    Time frame: 70 days

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

Acronym: PALANGI3

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 12, 2010
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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