CancerPhase 1PALANGI3NCT01046487
Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate
A Phase 1 study testing Imatinib mesylate, Cyclophosphamide (Dosing level 1 ), Imatinib mesylate, Cyclophosphamide (Dosing level 2) and Imatinib mesylate, Cyclophosphamide (Dosing level 3) in people with Cancer, run by Centre Oscar Lambret at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Imatinib mesylate, Cyclophosphamide (Dosing level 1 ), Imatinib mesylate, Cyclophosphamide (Dosing level 2) and Imatinib mesylate, Cyclophosphamide (Dosing level 3)
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Feb 2009to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medullary insufficiency
- Cystitis, haemorrhagic cystitis
- Hepatic porphyria
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Bergonié
Bordeaux, 33076
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69008
About this study
Official title: Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)
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).
- Conditions
- Cancer
- Being tested
- Imatinib mesylate, Cyclophosphamide (Dosing level 1 ), Imatinib mesylate, Cyclophosphamide (Dosing level 2), Imatinib mesylate, Cyclophosphamide (Dosing level 3), Blood sampling
- Keywords
- dermatofibrosarcoma, cylindroma, choroid melanoma, gastrointestinal stroma tumor, chordoma, ocular melanoma, conjunctival melanoma, malignant melanoma of the anus, gastric melanoma, desmoid tumor
- Medical subject headings
- Neoplasms, Dermatofibrosarcoma, Carcinoma, Adenoid Cystic, Uveal Melanoma, Gastrointestinal Stromal Tumors, Chordoma, Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 samplingProcedure or surgery
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
For safety: NCI-CTCAE scale version 3.0
Measured: 42 days
Secondary outcomes (1)
For anti tumoral efficiency : RECIST criteria
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study start9 Feb 2009
- Primary completionApr 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ADENIS, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046487
- Sponsor's protocol ID
- PALANGI3-0804
- Other IDs
- 2008-004212-12, 2008
- Acronym
- PALANGI3
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2010
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)
- ClinicalTrials.gov ID
- NCT01046487
- Acronym / sponsor ID
- PALANGI3 / PALANGI3-0804
- Conditions
- Cancer
- Keywords
- dermatofibrosarcoma, cylindroma, choroid melanoma, gastrointestinal stroma tumor, chordoma, ocular melanoma, conjunctival melanoma, malignant melanoma of the anus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 9 Feb 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Medullary insufficiency
- Cystitis, haemorrhagic cystitis
- Hepatic porphyria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib 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 | Drug | – |
| Imatinib 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 | Drug | – |
| Imatinib 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 | Drug | – |
| Blood samplingONLY 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) | Procedure or surgery | – |
Primary outcome
For safety: NCI-CTCAE scale version 3.0
Time frame: 42 days
1 secondary outcome
For anti tumoral efficiency : RECIST criteria
Time frame: 70 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine ADENIS, MD, PhD principal investigator
Centre Oscar Lambret
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imatinib mesylate, Cyclophosphamide (Dosing level 1 ), Imatinib mesylate, Cyclophosphamide (Dosing level 2) and Imatinib mesylate, Cyclophosphamide (Dosing level 3) in people with Cancer, run by Centre Oscar Lambret at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For safety: NCI-CTCAE scale version 3.0 (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.