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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01046487

Acronym

PALANGI3

Enrollment

Registered

2010-01-12

Start date

2009-02-09

Completion date

2012-02-01

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

dermatofibrosarcoma, cylindroma, choroid melanoma, gastrointestinal stroma tumor, chordoma, ocular melanoma, conjunctival melanoma, malignant melanoma of the anus, gastric melanoma, desmoid tumor

Brief summary

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).

Interventions

DRUGImatinib mesylate, Cyclophosphamide (Dosing level 1 )

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

DRUGImatinib mesylate, Cyclophosphamide (Dosing level 2)

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

DRUGImatinib mesylate, Cyclophosphamide (Dosing level 3)

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

PROCEDUREBlood sampling

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
For safety: NCI-CTCAE scale version 3.0	42 days

Secondary

Measure	Time frame
For anti tumoral efficiency : RECIST criteria	70 days

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAntoine ADENIS, MD, PhD

Centre Oscar Lambret

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026