Non GIST SarcomasPhase 1NCT01308034
Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
A Phase 1 study testing sunitinib in people with Non GIST Sarcomas, run by Centre Leon Berard at 6 sites in France.
Trial summary
The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non GIST Sarcomas
- What is being tested?
- sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2011to 21 Sep 2016
- 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
- Male or female patients > 18 years of age
- Histologically or cytologically (in case of recurrence) confirmed connective tissue neoplasm, including any of the following subtypes:
- Liposarcomas
- Fibrosarcoma, myxofibrosarcoma
- Undifferentiated pleomorphic sarcoma
- Leiomyosarcomas
Show all 27Show fewer
- Pleomorphic rhabdomyosarcomas only
- Angiosarcomas
- Uncertain differentiated tumors: synovial sarcomas, epithelioid sarcomas, alveolar sarcomas, clear cells sarcomas.
- or osteosarcoma diagnosis, chondrosarcoma or chordoma.
- Locally advanced or locally recurrent inoperable tumor without previous irradiation [inoperable status must be assessed by staff including a surgeon specialized in sarcoma].
- No prior treatment by sunitinib malate
- Life expectancy > 6 months
- ECOG performance status ≤ 2
- Blood tests, renal and liver functions in the normal range with, in the 7 days prior to study entry, blood or serum values as follows:
- Absolute neutrophil count ≥ 1.,5 G/L
- Platelet count ≥ 100 G/L
- Bilirubin ≤ 1.5 mg/dL
- PT and INR ≤ 1.5 times upper limit of normal [Patients under preventive anticoagulant therapy are allowed to participate]
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine ≤ 150 umol/L
- Calcium ≤ 12 mg/dL
- Blood glucose < 150 mg/dL
- Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study therapy
- Ability to swallow oral medications
- Mandatory affiliation with a health insurance company
- Signed written informed consent.
Who cannot join
- GIST, Ewing sarcoma or embryonic rhabdomyosarcomas
- Radiation field including lung, bowel, or central nervous system
- Pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication
- NCI grade ≥ 3 hemorrhage within the past 4 weeks prior to study drug administration
- Significant cardiovascular disease (New York Heart Association (NYHA) > grade 2 congestive cardiac failure, myocardial infarction within 6 months prior to inclusion, unstable angina, severe cardiac arrhythmia, severe cerebrovascular accident within 6 months prior to inclusion, history of severe thromboembolism (pulmonary embolism or deep vein thrombosis DVT) within 6 months prior to inclusion (patients with recent history of DVT treated by anticoagulant (except therapeutic warfarin)during at least 6 weeks are eligibles), prolonged QTc interval (QTc > 480 msec with Bazett), bradycardia (heart rate < 45bpm), electrolytic troubles (hyponatremia<120mmol/l, kalemia≥6mmol/l) or uncontrolled hypertension while receiving appropriate medication (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic).
- Less than 6 weeks between prior neoplastic treatment by tyrosine kinase inhibitor and inclusion and less than 4 weeks for other neoplastic treatments
Show all 16Show fewer
- Major surgical procedure, open biopsy, or serious non healing wound within 28 days prior to first day of treatment
- Concurrent participation in another clinical trial
- Other disease or illness within the past 6 months prior to study drug administration, including the following:
- Psychiatric illness or social situation that would preclude study compliance
- Known human immunodeficiency virus (HIV)- or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
- Known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease
- peritoneal carcinosis
- number of metastatic sites > 2
- Restriction of freedom by judicial or administrative decision
- Pregnant or lactating women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Institut Bergonié
Bordeaux
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon, 69373
CHU La Timone
Marseille
Institut de Cancérologie de l'ouest
Saint-Herblain
Institut Gustave Roussy
Villejuif
About this study
Official title: Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery.
The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery.
This study is a multicentre, open-label phase I with dose escalation : 2 dose levels.
3-6 patients will be included at each dose level.3-18 patients will be included in the study.
Read the detailed description
Study design : 2 dose levels
Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily
3-6 patients will be included at each of the sunitinib dose levels, depending on the number of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment
DLT is defined as :
any grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any other toxicity > or = 4
Secondary objectives are :
- to evaluate the safety with late toxicities
- to estimate the response rate at 6 months
- to estimate the progression free survival
- to evaluate the proportion of patients with an operable tumour after treatment
Exploratory objectives are :
- to study evolution during treatment of neo-angiogenesis measured by dynamic contrast enhanced-ultrasonography (DCE-US)
- to study the correlation between clinical response and changes of tumor perfusion measured by DCE-US
- Conditions
- Non GIST Sarcomas
- Being tested
- sunitinib
- Keywords
- non GIST sarcomas, sunitinib, radiotherapy, dose escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinibDrug
All patients will be treated with sunitinib (2 dose levels) once a day (in the morning) for 6 weeks in association with radiotherapy.Radiotherapy will be realised 1-4h after taking sunitinib.
Dose level 1 : 25 mg once daily Dose level 2 : 37.5 mg once daily Authorization to include a patient in the upper step will be given only if the deadline of 14 weeks after the start of treatment of last patient included were strictly respected and depending of number of DLT occuring.
| Study group | Role | What they receive |
|---|---|---|
| association sunitinib radiotherapy | Experimental | Not described Receives: Drug: sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of DLT occurring at each dose level of sunitinib within 14 weeks after the start of treatment
Measured: within 14 weeks after the start of treatment
Secondary outcomes (6)
the number of early toxicities (within 14 weeks after the beginning of treatment) and late toxicities (after 14 weeks and until 12 months after the start of treatment) using NCI-CTC v3.0 and RTOG-EORTC
Measured: within 12 months after the start of treatment
response rate at 6 months using MRI (magnetic resonance imaging)
Measured: 6 months after the start of treatment
progression free survival measured from the date of inclusion to the date of first evidence of progression or date of death of any cause, or to the date of last follow up
Measured: within 12 months after the start of treatment
evolution of neo-angiogenesis during treatment measured by DCE-US
Measured: within 6 weeks after the start of treatment
correlation between clinical response and change of tumor perfusion measured by DCE-US
Measured: within 12 months after the start of treatment
proportion of patients operable after treatment
Measured: at week 6 after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Non GIST SarcomasStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean Yves Blay, PR, Principal investigator, Centre Léon Bérard, LyonMarie Pierre Sunyach, Principal investigator, Centre Léon Bérard, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308034
- Sponsor's protocol ID
- RT - SUTENT
- Other IDs
- 2010-021551-11
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2011
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alektiar KM, Velasco J, Zelefsky MJ, Woodruff JM, Lewis JJ, Brennan MF. Adjuvant radiotherapy for margin-positive high-grade soft tissue sarcoma of the extremity. Int J Radiat Oncol Biol Phys. 2000 Nov 1;48(4):1051-8. doi: 10.1016/s0360-3016(00)00753-7.
PubMed 11072162Zagars GK, Ballo MT. Significance of dose in postoperative radiotherapy for soft tissue sarcoma. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):473-81. doi: 10.1016/s0360-3016(02)04573-x.
PubMed 12738323Tepper JE, Suit HD. Radiation therapy alone for sarcoma of soft tissue. Cancer. 1985 Aug 1;56(3):475-9. doi: 10.1002/1097-0142(19850801)56:33.0.co;2-s.
PubMed 4005809Schwartz DL, Einck J, Bellon J, Laramore GE. Fast neutron radiotherapy for soft tissue and cartilaginous sarcomas at high risk for local recurrence. Int J Radiat Oncol Biol Phys. 2001 Jun 1;50(2):449-56. doi: 10.1016/s0360-3016(00)01586-8.
PubMed 11380233Schmitt G, Pape H, Zamboglou N. Long term results of neutron- and neutron-boost irradiation of soft tissue sarcomas. Strahlenther Onkol. 1990 Jan;166(1):61-2.
PubMed 2154050Alektiar KM, Brennan MF, Healey JH, Singer S. Impact of intensity-modulated radiation therapy on local control in primary soft-tissue sarcoma of the extremity. J Clin Oncol. 2008 Jul 10;26(20):3440-4. doi: 10.1200/JCO.2008.16.6249.
PubMed 18612160Donnay L, Dejean C, Amsellem E, Bourezgui H, de Figueiredo BH, Duparc A, Caron J, Tournat H, Lagarde P, Stoeckle E, Kantor G. [Radiotherapy for soft tissue sarcomas of extremities. Preliminary comparative dosimetric study of 3D conformal radiotherapy versus helical tomotherapy]. Cancer Radiother. 2008 Dec;12(8):809-16. doi: 10.1016/j.canrad.2008.08.275. Epub 2008 Nov 28. French.
PubMed 19046919Folkman J. The role of angiogenesis in tumor growth. Semin Cancer Biol. 1992 Apr;3(2):65-71.
PubMed 1378311Jain RK. Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy. Science. 2005 Jan 7;307(5706):58-62. doi: 10.1126/science.1104819.
PubMed 15637262Overgaard J, Horsman MR. Modification of Hypoxia-Induced Radioresistance in Tumors by the Use of Oxygen and Sensitizers. Semin Radiat Oncol. 1996 Jan;6(1):10-21. doi: 10.1053/SRAO0060010.
PubMed 10717158Overgaard J. Hypoxic radiosensitization: adored and ignored. J Clin Oncol. 2007 Sep 10;25(26):4066-74. doi: 10.1200/JCO.2007.12.7878.
PubMed 17827455Hess C, Vuong V, Hegyi I, Riesterer O, Wood J, Fabbro D, Glanzmann C, Bodis S, Pruschy M. Effect of VEGF receptor inhibitor PTK787/ZK222584 [correction of ZK222548] combined with ionizing radiation on endothelial cells and tumour growth. Br J Cancer. 2001 Dec 14;85(12):2010-6. doi: 10.1054/bjoc.2001.2166.
PubMed 11747347Lee CG, Heijn M, di Tomaso E, Griffon-Etienne G, Ancukiewicz M, Koike C, Park KR, Ferrara N, Jain RK, Suit HD, Boucher Y. Anti-Vascular endothelial growth factor treatment augments tumor radiation response under normoxic or hypoxic conditions. Cancer Res. 2000 Oct 1;60(19):5565-70.
PubMed 11034104Li J, Huang S, Armstrong EA, Fowler JF, Harari PM. Angiogenesis and radiation response modulation after vascular endothelial growth factor receptor-2 (VEGFR2) blockade. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1477-85. doi: 10.1016/j.ijrobp.2005.04.028.
PubMed 16029810Cao C, Albert JM, Geng L, Ivy PS, Sandler A, Johnson DH, Lu B. Vascular endothelial growth factor tyrosine kinase inhibitor AZD2171 and fractionated radiotherapy in mouse models of lung cancer. Cancer Res. 2006 Dec 1;66(23):11409-15. doi: 10.1158/0008-5472.CAN-06-2414.
PubMed 17145887
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
- ClinicalTrials.gov ID
- NCT01308034
- Acronym / sponsor ID
- RT - SUTENT
- Conditions
- Non GIST Sarcomas
- Keywords
- non GIST sarcomas, sunitinib, radiotherapy, dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2011
- Primary completion
- May 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 3 Mar 2011 (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 safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery.
The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery.
This study is a multicentre, open-label phase I with dose escalation : 2 dose levels.
3-6 patients will be included at each dose level.3-18 patients will be included in the study.
Detailed description
Study design : 2 dose levels
Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily
3-6 patients will be included at each of the sunitinib dose levels, depending on the number of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment
DLT is defined as :
any grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any other toxicity > or = 4
Secondary objectives are :
- to evaluate the safety with late toxicities
- to estimate the response rate at 6 months
- to estimate the progression free survival
- to evaluate the proportion of patients with an operable tumour after treatment
Exploratory objectives are :
- to study evolution during treatment of neo-angiogenesis measured by dynamic contrast enhanced-ultrasonography (DCE-US)
- to study the correlation between clinical response and changes of tumor perfusion measured by DCE-US
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| association sunitinib radiotherapy | Experimental | Drug: sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male or female patients > 18 years of age
- Histologically or cytologically (in case of recurrence) confirmed connective tissue neoplasm, including any of the following subtypes:
- or osteosarcoma diagnosis, chondrosarcoma or chordoma.
- Locally advanced or locally recurrent inoperable tumor without previous irradiation [inoperable status must be assessed by staff including a surgeon specialized in sarcoma].
- No prior treatment by sunitinib malate
Key exclusion criteria (16 listed)
- GIST, Ewing sarcoma or embryonic rhabdomyosarcomas
- Radiation field including lung, bowel, or central nervous system
- Pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication
- NCI grade ≥ 3 hemorrhage within the past 4 weeks prior to study drug administration
- Significant cardiovascular disease (New York Heart Association (NYHA) > grade 2 congestive cardiac failure, myocardial infarction within 6 months prior to inclusion, unstable angina, severe cardiac arrhythmia, severe cerebrovascular accident within 6 months prior to inclusion, history of severe thromboembolism (pulmonary embolism or deep vein thrombosis DVT) within 6 months prior to inclusion (patients with recent history of DVT treated by anticoagulant (except therapeutic warfarin)during at least 6 weeks are eligibles), prolonged QTc interval (QTc > 480 msec with Bazett), bradycardia (heart rate < 45bpm), electrolytic troubles (hyponatremia<120mmol/l, kalemia≥6mmol/l) or uncontrolled hypertension while receiving appropriate medication (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic).
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 |
|---|---|---|
| sunitinibAll patients will be treated with sunitinib (2 dose levels) once a day (in the morning) for 6 weeks in association with radiotherapy.Radiotherapy will be realised 1-4h after taking sunitinib. Dose level 1 : 25 mg once daily Dose level 2 : 37.5 mg once daily Authorization to include a patient in the upper step will be given only if the deadline of 14 weeks after the start of treatment of last patient included were strictly respected and depending of number of DLT occuring. | Drug | association sunitinib radiotherapy |
Primary outcome
the number of DLT occurring at each dose level of sunitinib within 14 weeks after the start of treatment
Time frame: within 14 weeks after the start of treatment
6 secondary outcomes
the number of early toxicities (within 14 weeks after the beginning of treatment) and late toxicities (after 14 weeks and until 12 months after the start of treatment) using NCI-CTC v3.0 and RTOG-EORTC
Time frame: within 12 months after the start of treatment
response rate at 6 months using MRI (magnetic resonance imaging)
Time frame: 6 months after the start of treatment
progression free survival measured from the date of inclusion to the date of first evidence of progression or date of death of any cause, or to the date of last follow up
Time frame: within 12 months after the start of treatment
evolution of neo-angiogenesis during treatment measured by DCE-US
Time frame: within 6 weeks after the start of treatment
correlation between clinical response and change of tumor perfusion measured by DCE-US
Time frame: within 12 months after the start of treatment
proportion of patients operable after treatment
Time frame: at week 6 after the start of treatment
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 18 Jan 2022.
- Background: PubMed 11072162Alektiar KM, Velasco J, Zelefsky MJ, Woodruff JM, Lewis JJ, Brennan MF. Adjuvant radiotherapy for margin-positive high-grade soft tissue sarcoma of the extremity. Int J Radiat Oncol Biol Phys. 2000 Nov 1;48(4):1051-8. doi: 10.1016/s0360-3016(00)00753-7.
- Background: PubMed 12738323Zagars GK, Ballo MT. Significance of dose in postoperative radiotherapy for soft tissue sarcoma. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):473-81. doi: 10.1016/s0360-3016(02)04573-x.
- Background: PubMed 4005809Tepper JE, Suit HD. Radiation therapy alone for sarcoma of soft tissue. Cancer. 1985 Aug 1;56(3):475-9. doi: 10.1002/1097-0142(19850801)56:33.0.co;2-s.
- Background: PubMed 11380233Schwartz DL, Einck J, Bellon J, Laramore GE. Fast neutron radiotherapy for soft tissue and cartilaginous sarcomas at high risk for local recurrence. Int J Radiat Oncol Biol Phys. 2001 Jun 1;50(2):449-56. doi: 10.1016/s0360-3016(00)01586-8.
- Background: PubMed 2154050Schmitt G, Pape H, Zamboglou N. Long term results of neutron- and neutron-boost irradiation of soft tissue sarcomas. Strahlenther Onkol. 1990 Jan;166(1):61-2.
- Background: PubMed 18612160Alektiar KM, Brennan MF, Healey JH, Singer S. Impact of intensity-modulated radiation therapy on local control in primary soft-tissue sarcoma of the extremity. J Clin Oncol. 2008 Jul 10;26(20):3440-4. doi: 10.1200/JCO.2008.16.6249.
- Background: PubMed 19046919Donnay L, Dejean C, Amsellem E, Bourezgui H, de Figueiredo BH, Duparc A, Caron J, Tournat H, Lagarde P, Stoeckle E, Kantor G. [Radiotherapy for soft tissue sarcomas of extremities. Preliminary comparative dosimetric study of 3D conformal radiotherapy versus helical tomotherapy]. Cancer Radiother. 2008 Dec;12(8):809-16. doi: 10.1016/j.canrad.2008.08.275. Epub 2008 Nov 28. French.
- Background: PubMed 1378311Folkman J. The role of angiogenesis in tumor growth. Semin Cancer Biol. 1992 Apr;3(2):65-71.
- Background: PubMed 15637262Jain RK. Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy. Science. 2005 Jan 7;307(5706):58-62. doi: 10.1126/science.1104819.
- Background: PubMed 10717158Overgaard J, Horsman MR. Modification of Hypoxia-Induced Radioresistance in Tumors by the Use of Oxygen and Sensitizers. Semin Radiat Oncol. 1996 Jan;6(1):10-21. doi: 10.1053/SRAO0060010.
- Background: PubMed 17827455Overgaard J. Hypoxic radiosensitization: adored and ignored. J Clin Oncol. 2007 Sep 10;25(26):4066-74. doi: 10.1200/JCO.2007.12.7878.
- Background: PubMed 11747347Hess C, Vuong V, Hegyi I, Riesterer O, Wood J, Fabbro D, Glanzmann C, Bodis S, Pruschy M. Effect of VEGF receptor inhibitor PTK787/ZK222584 [correction of ZK222548] combined with ionizing radiation on endothelial cells and tumour growth. Br J Cancer. 2001 Dec 14;85(12):2010-6. doi: 10.1054/bjoc.2001.2166.
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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.
Jean Yves Blay, PR principal investigator
Centre Léon Bérard, Lyon
Marie Pierre Sunyach principal investigator
Centre Léon Bérard, Lyon
6 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 sunitinib in people with Non GIST Sarcomas, run by Centre Leon Berard at 6 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 27 inclusion and 16 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
the number of DLT occurring at each dose level of sunitinib within 14 weeks after the start of treatment (time frame: within 14 weeks after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01308034, which also lists 41 linked publications.
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 18 Jan 2022.