Hematologic CancersPhase 2AcSéNCT02034981
Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1
A Phase 2 study testing Crizotinib in people with Hematologic Cancers and Solid Tumors, run by UNICANCER at 1 site in France.
Trial summary
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hematologic Cancers, Solid Tumors, Metastatic Cancer
- What is being tested?
- Crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to 6 Dec 2023
- Phase
- Phase 2
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female ≥ 1 year of age
- unresectable locally advanced or metastatic malignant tumor of any histological type (but NSCLC with an ALK translocation) and not amenable to any other validated therapeutic option. ( for pediatrics a relapse after a first well-conducted standard treatment or a situation without any standard treatment and a survival <10%).
- one proven specific alterations among ALK, MET, RON and ROS1 genes determined on the primary and/or the metastatic lesion
- Measurable disease according to RECIST 1.1
- For patients with primary cerebral tumors (adults or children), measurable disease defined by bi-dimensional measurements : two perpendicular diameters of at least 10 mm on CT or MRI scan, outside of a previously radiated field within the last 3 months, to observe pseudoprogression
- hematologic function (ANC ≥ 1.0x10⁹/L, platelets ≥ 75x10⁹/L, platelets ≥ 50x10⁹/L for ALCL with bone marrow involved ; platelets ≥ 100x10⁹/L for primary or secondary cerebral tumors; Hb ≥ 8g/L), renal function (creat cl ≥ 50 mL/min Cockcroft and Gault) and hepatic function (serum bilirubin ≤ 1.5x ULN unless due to Gilbert's syndrome ; ASAT and ALAT ≤ 5x ULN if liver metastasis or ≤ 3x ULN if liver metastasis with advanced fibrosis (FibroTest>0.48) or ≤ 3x ULN without liver metastasis)
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- normal values for calcium, magnesium and potassium levels
- able to swallow and retain oral medication
- ECOG Performance Status of 0 to 2, or Karnofsky scale > 50 % or Lansky Play scale (< 12 years) > 50%, (for CNS tumors, the neurological deficiency due to the disease itself)
- Life expectancy ≥ 3 months
Who cannot join
- NSCLC patients ALK translocations
- Patient eligible for a clinical trial with an anticancer drug (including crizotinib) targeting the same molecular alteration open to accrual in France.
- alteration limited to an overexpression of ALK, MET, RON, ROS1 or any other crizotinib-target. Only patients with ALCL are eligible if ALK is positive by immunohistochemistry
- Patients with primary or secondary central nervous system disease
- Previous treatment with crizotinib
- Major surgery or tumor embolization within 4 weeks and minor surgery within 2 weeks prior to the initiation of the study drug. Brain surgery is excluded within 4 weeks prior to starting crizotinib for primary or secondary cerebral tumors
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- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to :
- Within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack
- Ongoing congestive heart failure
- Congenital long QT syndrome
- Heart rate ≤ 45 beats/minute
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, or with QTcF interval >470 msec
- For patients with a cerebral disease (primary or secondary) : uncontrolled hypertension [defined as SBP of ≥ 140 mmHg or DBP of ≥ 90mmHg]
- extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not prior radiation pneumonitis
- Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function
- Carcinomatous meningitis or leptomeningeal disease
- HIV-positive, active hepatitis A, B or C, or latent hepatitis B or C, or any other uncontrolled infection
- Other severe acute or chronic medical or psychiatric conditions, or end stage renal disease on hemodialysis or laboratory abnormalities
- For patients with a cerebral disease, detection on the MRI or the CTscan of a real arteriovenous malformation, or an untreated intracranial aneurysm, or a cavernous angioma, or an amyloid angiopathy, or any new or significant (≥ grade 2) intratumoral bleeding other than microbleeds on T2* weighted MRI in the previous 14 days before treatment initiation, or a recent and untreated subdural effusion.
- Patients using non-substitutable drugs that are potent CYP3A4 inhibitors, or potent CYP3A4 inducers
- Patients using non-substitutable drugs that are CYP3A4 substrates with narrow therapeutic indices
- Patients with cerebral disease using anti-platelet drugs or anticoagulant agents are not eligible if those treatments can not be stopped 7 days before day1.
- Patients with altered mental status or with psychological, familial, sociological or geographical condition potentially hampering compliance
- Individual deprived of liberty or placed under the authority of a tutor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug.
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification).
For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.
Read the detailed description
Twenty cohorts are identified, a cohort being defined as [one pathology, one target alteration] such as [gastric cancer with MET amplification (6%)].
One cohort will be dedicated to miscellaneous, very rare pediatric diseases identified through INCa platforms or pan-genome programs (e.g. MOSKIDO, IGR) and will recruit up to 10 patients.
Two cohorts will be dedicated to a couple of diseases harbouring at least one specific alteration in one crizotinib target, same or different from those listed above, e.g. in AXL gene, arising from pan-genome trials.
- ALCL, adults and children, ALK-translocated
- Colorectal cancer, adults, ALK-translocated
- Colorectal cancer, adults, MET amplified
- Colorectal cancer, adults, MET mutated
- NSCLC, adults, MET amplified
- NSCLC, adults, ROS1-translocated
- Breast cancer, adults, ALK-translocated
- Gastric cancer, adults, MET amplified
- Cholangiocarcinoma, adults, ROS1-translocated
- Ovarian cancer, adults, MET amplified
- Clear cell renal cell carcinoma, adults, ALK-translocated
- Clear cell renal cell carcinoma, adults, ALK-amplified
- Papillary renal cell carcinoma, adults, MET mutated (+ MET amplified)
- Hepatocarcinoma, adults, MET amplified
- Neuroblastoma, adults and children, ALK-amplified + ALK mutated
- IMT, adults and children, ALK-translocated
- Rhabdomyosarcoma (alveolar and embryonal), adults and children, ALK-amplified
- Glioblastoma, adults, MET amplified. This cohort will only be open after amendment
- Anaplastic thyroid cancer, adults, ALK mutated
- Thyroid cancer (follicular + medullary + papillary), adults, MET mutated
- Miscellaneous rare pediatric diseases associated to at least one specific alteration in one crizotinib target, same or different from those listed above
- One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.
- One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.
- Conditions
- Hematologic Cancers, Solid Tumors, Metastatic Cancer
- Being tested
- Crizotinib
- Keywords
- metastatic or unresectable locally advanced malignancies., genomic alterations., biological crizotinib targets (ALK, MET, ROS1, RON, AXL).
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizotinibDrug
Also called XALKORI
Patients will receive oral crizotinib, daily continuously, until progression or unacceptable toxicity develops.
-250 mg twice daily for adults ≥ 18 years of age
- 280 mg/m² twice daily for children and adolescents aged from 1 to 17 (except ALCL).
- 165 mg/m² twice daily for ALCL patients aged from 1 to 17.
| Study group | Role | What they receive |
|---|---|---|
| CRIZOTINIB | Experimental | All eligible patients entering the study will receive oral crizotinib as monotherapy Receives: Drug: Crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of crizotinib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the crizotinib target genes, per cohort, per pathology, and per target.
Anti-tumor activity of crizotinib, as the primary objective of the trial, will be carried out by the determination of the objective response assessed in each cohort defined by a pathology associated with a crizotinib target alteration.
The objective response is defined as either a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
The objective response after 2 cycles (8 weeks) will be reported to define a success in the 2-stage design.
Measured: Determined after 8 weeks (2 cycles) of treatment
Secondary outcomes (5)
The safety profile of crizotinib.
Toxicities will be assessed by clinical and paraclinical examinations at every scheduled visit during the whole treatment period and the post-treatment follow-up period (around 2.5 years) This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
Measured: Safety profile will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period, and reported during the visits scheduled by the study flow chart
Disease control rate
Disease Control Rate will be the percentage of patients with a CR, PR or Stable Disease (SD) according to RECIST at the end of cycle 2 (8 weeks) and at the end of cycle 4 (16 weeks) in the group of patients evaluable for response
Measured: After 8 weeks (2 cycles) and 16 weeks (4 cycles) of treatment
response duration
Response duration will be the time interval between the date that the criteria of CR/PR (whichever is first recorded) are met for the first time and the first date of documented re-appearance of the disease (recurrence, progression or death). If neither event has been observed, then the patient is censored at the date of the last follow up examination.
Measured: interval between the objective response (CR or PR) and time of progression, recurrence or death
Progression-free survival
Progression-free survival will be the time interval between the date of registration and the day of first documented sign of disease progression (first day when RECIST criteria of progression are met) or day of death whatever the cause (events). If neither event has been observed, then the patient is censored at the date of the last follow up examination.
Measured: from registration until time of disease progression or death
Overall survival
Overall survival will be the time interval between the date of registration and the date of death, whatever the cause of death. Patients still alive at follow-up are censored at the date of last follow up.
Measured: from registration until date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionJun 2019
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematologic CancersStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034981
- Sponsor's protocol ID
- UC-0105/1303
- Other IDs
- 2013-000885-13
- Acronym
- AcSé
- Status last verified
- Feb 2024
- First submitted
- 16 Oct 2013
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brugieres L, Cozic N, Houot R, Rigaud C, Sibon D, Arfi-Rouche J, Bories P, Cottereau AS, Delmer A, Ducassou S, Garnier N, Lamant L, Leruste A, Millot F, Moalla S, Morschhauser F, Nolla M, Pagnier A, Reguerre Y, Renaud L, Schmitt A, Simonin M, Verschuur A, Hoog Labouret N, Mahier Ait Oukhatar C, Vassal G. Efficacy and safety of crizotinib in ALK-positive systemic anaplastic large-cell lymphoma in children, adolescents, and adult patients: results of the French AcSe-crizotinib trial. Eur J Cancer. 2023 Sep;191:112984. doi: 10.1016/j.ejca.2023.112984. Epub 2023 Jul 17.
PubMed 37549532Aparicio T, Cozic N, de la Fouchardiere C, Meriaux E, Plaza J, Mineur L, Guimbaud R, Samalin E, Mary F, Lecomte T, Gomez-Roca C, Haineaux PA, Gratet A, Selves J, Menu Y, Colignon N, Johnson L, Legrand F, Vassal G. The Activity of Crizotinib in Chemo-Refractory MET-Amplified Esophageal and Gastric Adenocarcinomas: Results from the AcSe-Crizotinib Program. Target Oncol. 2021 May;16(3):381-388. doi: 10.1007/s11523-021-00811-8. Epub 2021 Apr 13.
PubMed 33847874Moro-Sibilot D, Cozic N, Perol M, Mazieres J, Otto J, Souquet PJ, Bahleda R, Wislez M, Zalcman G, Guibert SD, Barlesi F, Mennecier B, Monnet I, Sabatier R, Bota S, Dubos C, Verriele V, Haddad V, Ferretti G, Cortot A, De Fraipont F, Jimenez M, Hoog-Labouret N, Vassal G. Crizotinib in c-MET- or ROS1-positive NSCLC: results of the AcSe phase II trial. Ann Oncol. 2019 Dec 1;30(12):1985-1991. doi: 10.1093/annonc/mdz407.
PubMed 31584608
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug.
- ClinicalTrials.gov ID
- NCT02034981
- Acronym / sponsor ID
- AcSé / UC-0105/1303
- Conditions
- Hematologic Cancers, Solid Tumors, Metastatic Cancer
- Keywords
- metastatic or unresectable locally advanced malignancies., genomic alterations., biological crizotinib targets (ALK, MET, ROS1, RON, AXL).
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Fondation ARC, Pfizer
- Study start
- Aug 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 14 Jan 2014 (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.
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification).
For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.
Detailed description
Twenty cohorts are identified, a cohort being defined as [one pathology, one target alteration] such as [gastric cancer with MET amplification (6%)].
One cohort will be dedicated to miscellaneous, very rare pediatric diseases identified through INCa platforms or pan-genome programs (e.g. MOSKIDO, IGR) and will recruit up to 10 patients.
Two cohorts will be dedicated to a couple of diseases harbouring at least one specific alteration in one crizotinib target, same or different from those listed above, e.g. in AXL gene, arising from pan-genome trials.
- ALCL, adults and children, ALK-translocated
- Colorectal cancer, adults, ALK-translocated
- Colorectal cancer, adults, MET amplified
- Colorectal cancer, adults, MET mutated
- NSCLC, adults, MET amplified
- NSCLC, adults, ROS1-translocated
- Breast cancer, adults, ALK-translocated
- Gastric cancer, adults, MET amplified
- Cholangiocarcinoma, adults, ROS1-translocated
- Ovarian cancer, adults, MET amplified
- Clear cell renal cell carcinoma, adults, ALK-translocated
- Clear cell renal cell carcinoma, adults, ALK-amplified
- Papillary renal cell carcinoma, adults, MET mutated (+ MET amplified)
- Hepatocarcinoma, adults, MET amplified
- Neuroblastoma, adults and children, ALK-amplified + ALK mutated
- IMT, adults and children, ALK-translocated
- Rhabdomyosarcoma (alveolar and embryonal), adults and children, ALK-amplified
- Glioblastoma, adults, MET amplified. This cohort will only be open after amendment
- Anaplastic thyroid cancer, adults, ALK mutated
- Thyroid cancer (follicular + medullary + papillary), adults, MET mutated
- Miscellaneous rare pediatric diseases associated to at least one specific alteration in one crizotinib target, same or different from those listed above
- One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.
- One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRIZOTINIB | Experimental | Drug: CrizotinibAll eligible patients entering the study will receive oral crizotinib as monotherapy |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female ≥ 1 year of age
- unresectable locally advanced or metastatic malignant tumor of any histological type (but NSCLC with an ALK translocation) and not amenable to any other validated therapeutic option. ( for pediatrics a relapse after a first well-conducted standard treatment or a situation without any standard treatment and a survival <10%).
- one proven specific alterations among ALK, MET, RON and ROS1 genes determined on the primary and/or the metastatic lesion
- Measurable disease according to RECIST 1.1
- For patients with primary cerebral tumors (adults or children), measurable disease defined by bi-dimensional measurements : two perpendicular diameters of at least 10 mm on CT or MRI scan, outside of a previously radiated field within the last 3 months, to observe pseudoprogression
Key exclusion criteria (24 listed)
- NSCLC patients ALK translocations
- Patient eligible for a clinical trial with an anticancer drug (including crizotinib) targeting the same molecular alteration open to accrual in France.
- alteration limited to an overexpression of ALK, MET, RON, ROS1 or any other crizotinib-target. Only patients with ALCL are eligible if ALK is positive by immunohistochemistry
- Patients with primary or secondary central nervous system disease
- Previous treatment with crizotinib
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 |
|---|---|---|
| CrizotinibAlso: XALKORIPatients will receive oral crizotinib, daily continuously, until progression or unacceptable toxicity develops. -250 mg twice daily for adults ≥ 18 years of age * 280 mg/m² twice daily for children and adolescents aged from 1 to 17 (except ALCL). * 165 mg/m² twice daily for ALCL patients aged from 1 to 17. | Drug | CRIZOTINIB |
Primary outcome
The efficacy of crizotinib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the crizotinib target genes, per cohort, per pathology, and per target.
Time frame: Determined after 8 weeks (2 cycles) of treatment
Anti-tumor activity of crizotinib, as the primary objective of the trial, will be carried out by the determination of the objective response assessed in each cohort defined by a pathology associated with a crizotinib target alteration. The objective response is defined as either a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The objective response after 2 cycles (8 weeks) will be reported to define a success in the 2-stage design.
5 secondary outcomes
The safety profile of crizotinib.
Time frame: Safety profile will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period, and reported during the visits scheduled by the study flow chart
Disease control rate
Time frame: After 8 weeks (2 cycles) and 16 weeks (4 cycles) of treatment
response duration
Time frame: interval between the objective response (CR or PR) and time of progression, recurrence or death
Progression-free survival
Time frame: from registration until time of disease progression or death
Overall survival
Time frame: from registration until date of death
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 28 Feb 2024.
- Derived from this study: PubMed 37549532Brugieres L, Cozic N, Houot R, Rigaud C, Sibon D, Arfi-Rouche J, Bories P, Cottereau AS, Delmer A, Ducassou S, Garnier N, Lamant L, Leruste A, Millot F, Moalla S, Morschhauser F, Nolla M, Pagnier A, Reguerre Y, Renaud L, Schmitt A, Simonin M, Verschuur A, Hoog Labouret N, Mahier Ait Oukhatar C, Vassal G. Efficacy and safety of crizotinib in ALK-positive systemic anaplastic large-cell lymphoma in children, adolescents, and adult patients: results of the French AcSe-crizotinib trial. Eur J Cancer. 2023 Sep;191:112984. doi: 10.1016/j.ejca.2023.112984. Epub 2023 Jul 17.
- Derived from this study: PubMed 33847874Aparicio T, Cozic N, de la Fouchardiere C, Meriaux E, Plaza J, Mineur L, Guimbaud R, Samalin E, Mary F, Lecomte T, Gomez-Roca C, Haineaux PA, Gratet A, Selves J, Menu Y, Colignon N, Johnson L, Legrand F, Vassal G. The Activity of Crizotinib in Chemo-Refractory MET-Amplified Esophageal and Gastric Adenocarcinomas: Results from the AcSe-Crizotinib Program. Target Oncol. 2021 May;16(3):381-388. doi: 10.1007/s11523-021-00811-8. Epub 2021 Apr 13.
- Derived from this study: PubMed 31584608Moro-Sibilot D, Cozic N, Perol M, Mazieres J, Otto J, Souquet PJ, Bahleda R, Wislez M, Zalcman G, Guibert SD, Barlesi F, Mennecier B, Monnet I, Sabatier R, Bota S, Dubos C, Verriele V, Haddad V, Ferretti G, Cortot A, De Fraipont F, Jimenez M, Hoog-Labouret N, Vassal G. Crizotinib in c-MET- or ROS1-positive NSCLC: results of the AcSe phase II trial. Ann Oncol. 2019 Dec 1;30(12):1985-1991. doi: 10.1093/annonc/mdz407.
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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.
Gilles VASSAL principal investigator
Gustave Roussy, Villejuif
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crizotinib in people with Hematologic Cancers and Solid Tumors, run by UNICANCER at 1 site 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 10 inclusion and 24 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 efficacy of crizotinib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the crizotinib target genes, per cohort, per pathology, and per target. (time frame: Determined after 8 weeks (2 cycles) 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 NCT02034981, which also lists 3 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 28 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.