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Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment (MOST plus)

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ClinicalTrials.gov Identifier: NCT02029001
Recruitment Status : Recruiting
First Posted : January 7, 2014
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Leon Berard

Brief Summary:

The MOST Plus study is a two-period phase II clinical trial, conducted in patients with all types of progressive solid tumors after at least 1 prior systemic treatment regimen for advanced disease (in the absence of a validated second line therapy).

The main goal of this study is to evaluate for these patients the clinical benefit of a maintenance treatment in patients with stable disease (SD) after induction treatment with a selected therapy (Molecular Targeted Therapy (MTT) or with SD, partial response (PR) or complete reponse (CR) with Immunotherapy (IT)).

For MTT, the first period of this trial (induction period) will enable to establish whether the identification of genomic alterations in genes encoding for "actionable" targets in the tumor cells, regardless of the histological subtype, can be used to select efficient treatment targeting the pathway activated by the mutation.

For Immunotherapy, induction period with durvalumab + tremelimumab is expected to be an innovative therapy for an efficient tumor control and may allow to identify types of cancer or molecular types of cancer that are more receptive to immunotherapy.

For all treatments, the second period (maintenance period) will use a randomized design to evaluate the clinical benefit of a maintenance treatment with the targeted therapy or immunotherapy selected based on tumor molecular profile in patients treated by MTT with SD and in patients treated by IT with SD, PR or CR.

Each patient enrolled will receive the matching targeted therapy during 12 weeks (MTT) or 52 weeks (IT). At the end of this induction period:

MTT cohorts :

  • patients with a tumor response (CR: complete response or PR: partial response) will continue the targeted therapy,
  • patients in progression will discontinue the targeted therapy and will be withdrawn from study and oriented towards standard treatments
  • patients with a stable disease at 12 weeks will be randomized in order to determine if they continue or stop the therapy.

IT cohort :

- patients with SD, PR or CR at 52 weeks will be randomized in order to determine if they continue or stop the therapy.

For each MTT treatment group: ~80 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm).

For IT treatment group: ~125 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm).

In total (for 7 treatment groups): ~ 600 patients treated in the induction period and 350 patients randomized in maintenance period.


Condition or disease Intervention/treatment Phase
Malignant Solid Neoplasms Drug: Nilotinib (400 mg BID) Drug: Everolimus (10 mg QD) Drug: Sorafenib (400 mg BID) Drug: Lapatinib (1500 mg QD) Drug: Pazopanib (800 mg QD) Drug: Olaparib (300 mg BID) Combination Product: Durvalumab + Tremelimumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-period, Multicenter, Randomized, Open-label, Phase II Study Evaluating the Clinical Benefit of a Maintenance Treatment Targeting Tumor Molecular Alterations in Patients With Progressive Locally-advanced or Metastatic Solid Tumors
Actual Study Start Date : March 2014
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : October 2026

Arm Intervention/treatment
Experimental: Arm A: Maintenance treatment

Patients will continue targeted treatment matching the molecular alterations identified in their tumor

  • for a maximum of 136 weeks starting from the date of patient's first study drug intake following inclusion or a discontinuation criteria (unacceptable toxicity, interruption of study drug more than 28 days, documented on-treatment disease progression, patient decision, investigator decision, pregnancy) is met for nilotinib, everolimus, sorafenib, lapatinib, pazopanib, olaparib.
  • until loss of clinical benefit, or until a permanent study drug discontinuation criteria is met (unacceptable toxicity, interruption of study drug more than 28 days, documented on-treatment disease progression, patient decision, investigator decision, pregnancy) for durvalumab + tremelimumab
Drug: Nilotinib (400 mg BID)
Patient with advanced pigmented villonodular synovitis and tumors with mutations of ABL1, KIT, PDGFRA, PDGFRB, DDR1, DDR2, CSF1R, or amplification/translocation of the genes and/or of the ligands.
Other Name: Open cohort

Drug: Everolimus (10 mg QD)
Patients whose tumor harbors mutations or amplification of the PIK3CA, PIK3R1, AKT1, AKT2, mTOR, RICTOR, RAPTOR genes, or with TSC1, TSC2 or PTEN loss (defined as complete loss of both gene copies OR loss of one copy + mutation on the other copy or loss of one copy + loss of expression using immunohistochemistry).
Other Name: Closed cohort

Drug: Sorafenib (400 mg BID)
Patients whose tumor harbors mutations of VEGFR1-3, PDGFRB, FLT3, BRAF (other than V600 mutations), CRAF, HRAS, KRAS or RET or amplification/translocation of the genes and/or of the ligands.
Other Name: Closed cohort

Drug: Lapatinib (1500 mg QD)
Patients whose tumor harbors mutations or amplifications of HER2
Other Name: Closed cohort

Drug: Pazopanib (800 mg QD)
Patients whose tumor harbors mutations of VEGFR1-3, PDGFRA, PDGFRB or KIT* or amplification /translocation of the genes and/or of the ligands.
Other Name: Open cohort

Drug: Olaparib (300 mg BID)
Mutation BRCA1/2 (somatic and germline) or BRCA like and mutations of HDR pathway genes (RAD51 family gene, PALB2, ATM, etc...); except in stomach; except for patients eligible to Olaparib's available labels in France.
Other Name: Open cohort

Combination Product: Durvalumab + Tremelimumab
Any molecular types of tumor (which are known to be immunogenic or with high mutation load), except lung, urothelial and head and neck or CNS tumors, or patients who fulfill conditions to receive any other MTT of the MOST Plus study.
Other Name: Open cohort

No Intervention: Arm B:Interruption of targeted treatment

Targeted treatment received during induction period will be discontinued until a first documented off-treatment disease progression occurs. At progression, treatment reintroduction may be proposed to the patient (left at the investigator's appreciation, and upon patient approval).

Treatment may be continued until on-treatment disease progression, unacceptable toxicity or for a maximum of 136 weeks from the date of patient's first study drug intake following inclusion for nilotinib, everolimus, sorafenib, lapatinib, pazopanib, olaparib or until loss of clinical benefit, or until a permanent study drug discontinuation criteria is met for durvalumab + tremelimumab.

If the investigator considers that the treatment cannot be safely reintroduced (regarding patient's condition and/or laboratory results), the patient will be withdrawn from study.




Primary Outcome Measures :
  1. Induction Progression-Free Rate after induction treatment [ Time Frame: 12 weeks for MTT or 52 weeks for IT after initiation of study treatment ]
    The proportion of patients without documented disease progression within induction period (the first 12 weeks of study treatment or 52 weeks for IT).

  2. Progression-Free Survival (PFS) in both study arms after randomization [ Time Frame: 16 weeks after randomisation date ]
    Measured from the date of randomization until the date of event defined as the first documented progression or death from any cause. Patients with no event at the time of the analysis will be censored at the date of the last available tumor assessment.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Over the induction period ]
    Proportion of patients with complete response (CR) or partial response (PR) as best overall response over the induction period.

  2. Overall survival (OS) [ Time Frame: from the date of randomization to the date of death from any cause ]
  3. Patient's quality of life score (QLQ-C30) in both arms after randomization [ Time Frame: At randomization (week 12 for MTT or week 52 for IT), 16 weeks after randomisation (week 28 for MTT or week 68 for IT) and end of study for patient (week 136 for MTT or until up to 130 months after treatment start for IT) ]
  4. Safety assessment [ Time Frame: Over the whole study ]
    Type, frequency, seriousness and causality of adverse events reported from treatment initiation based on the common toxicity criteria grade (NCI CTC-AE-V4.03)


Other Outcome Measures:
  1. Duration of response (exploratory outcome) [ Time Frame: Over the whole study ]
    Measured from the time of first documented response (CR or PR) until the first documented disease progression or death due to underlying cancer, and censored at the date of the last available tumor assessment

  2. Medico-economic evaluation: cost analysis and cost-effectiveness analysis [ Time Frame: From randomization until patient's end of study ]

    Incremental cost-effectiveness ratios (ICERs) will be expressed as:

    • the cost per life year gained;
    • the cost per progression-free year gained.

  3. Progression Free Survival (exploratory outcome) [ Time Frame: Through study completion, an average of 1 year ]
    Measured from the date of the first administration of the treatment until the date of event defined as the first documented progression or death from any cause. Patients with no event at the time of the analysis will be censored at the date of the last available tumor assessment.

  4. Molecular evolution of tumor at progression (for olaparib and durvalumab + tremelimumab groups) [ Time Frame: Through study completion, an average of 1 year ]
    ctDNA analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

I1. Male or female patient ≥ 18 years of age.

I2. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced and unresectable solid tumor of any type, except for Nilotinib cohort: only pigmented villonodular synovitis are eligible, not amenable to curative treatment. Concerning primitive tumors of the central nervous system (CNS), all histological types of malignant tumors (including parenchymal and meningeal tumors) are eligible (except for IT).

I3. Documented disease progression at the time of study entry.

I4. At least one prior systemic treatment regimen for locally advanced or metastatic disease. Patients who are candidates for a validated second line treatment regimen are not eligible for the study. For patients with a primitive CNS tumor, the absence of other therapeutic options must be validated by the reference committee for the patient's pathology before inclusion. As there is no prior systemic treatment regimen available for locally advanced or metastatic PEComa, these tumors are eligible for a MTT treatment in first line of their advanced or metastatic disease. No previous treatment by immunotherapy is allowed for IT group.

I5. Patient with measurable disease, defined as at least one lesion that can be accurately measured on CT-scan or MRI according to RECIST 1.1.

I6. A multidisciplinary molecular board must have recommended one of the investigational MTT available in the study after review of a tumor molecular profiling previously established from a biopsied lesion and/or primitive tumor.

I7. The MTT recommended by the multidisciplinary molecular board after the review of tumor molecular profile is not approved and reimbursed in France for the disease affecting the patient in the same label.

I8. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

I9. Adequate organ system function as assessed by the following minimal laboratory requirements :

  • Absolute neutrophil count (ANC) ≥ 1 x 109/L (for pazopanib and olaparib: ≥ 1.5 x 109/L)
  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL. Transfusion is not allowed within 7 days of screening assessment. (For olaparib: Hemoglobin ≥ 10 g/dL. Transfusion is not allowed within 28 days of screening assessment, no features suggestive of myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) on peripheral blood smear within the 28 days)
  • For pazopanib: activated partial thromboplastin time (aPTT) ≤ 1.2x Upper limit of normal (ULN) and prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2x ULN; Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation.
  • Aspartate Aminotransferase (AST) and alanine transaminase (ALT) ≤ 3x ULN in the absence of liver metastases (≤ 5x ULN for patients with liver involvement of their cancer) and total bilirubin ≤ 1.5x ULN. (for pazopanib: AST and ALT ≤ 2.5x ULN; concomitant elevations in bilirubin and AST or ALT above 1x ULN are not permitted; for olaparib and IT: AST and ALT ≤ 2.5x ULN in the absence of liver metastases (≤ 5x ULN for patients with liver involvement of their cancer) and total bilirubin ≤ 1.5x ULN.).
  • Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula, or modification of diet in renal disease (MDRD) formula for patients older than 65 years) (for pazopanib: creatinine clearance ≥ 30 mL/min; for olaparib : creatinine clearance ≥ 51 mL/min; for IT : creatinine clearance ≥ 40 mL/min )
  • For pazopanib: Urine Protein to Creatinine ratio (UPC) <1; if UPC ≥1, 24-hour urine protein must be <1g (use of urine dipstick for renal function assessment is not acceptable).
  • Corrected QT (QTc) interval ≤ 450 msecs (≤ 480 msecs if recommended MTT has no known effect on QT interval) on screening ECG, within 14 days prior to C1D1 (for olaparib : QTc < 470 msec on 2 or more time points within a 24 hour period on screening ECG, within 7 days prior to C1D1).

I10. Life expectancy of at least 4 months.

I11. Specific toxicities related to any prior anti-cancer therapy must have resolved to grade ≤1 (defined by the NCI-CTCAE v4.03) except for alopecia, vitiligo and fatigue. Grade 2 neutropenia or anemia is accepted.

I12. Women of childbearing potential must have a negative pregnancy test performed within 3 days prior to study treatment start. A positive urine test must be confirmed by a serum pregnancy test.

I13. Women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test) and men of reproductive potential must agree, if sexually active, to use two methods of medically acceptable forms of contraception during the study and for at least 8 weeks following the last treatment intake. (for olaparib : during the study and for at least 1 month for women and 3 months for men following the last treatment intake; for IT : during the study and for at least 3 months following the last treatment intake). Refrain from breastfeeding (for nilotinib cohort : not breast-feed for at least two weeks after the last dose of nilotinib) and egg cell donation. Males should not donate sperm during or for 3 months after treatment I14. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.

I15. The patient must be affiliated to the French social security system.

I16. The recommended study treatment must have been approved by the medical staff of the Steering committee.

I17. Patient should be able and willing to comply with study visits and procedures as per protocol.

I18. Patient must fulfill ALL following conditions (criteria only applicable for Durvalumab + Tremelimumab cohort):

  • Availability of a pre-treatment sample of primary tumor (only formalin-fixed paraffin-embedded (FFPE) block with sufficient material) and presence of at least one biopsiable tumor lesion for on-treatment biopsy,
  • Weight > 50 Kg,
  • Patient with a maximum of 2 prior lines of treatment at time of C1D1 for their metastatic or locally advanced.

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria:

E1. Previous treatment in advanced phase with an investigational therapy inhibiting the same target proteins as this recommended for the study.

E2. Any contra-indication to receive the recommended MTT, including known or suspected hypersensitivity to compounds of similar chemical or biologic composition as the active substance, or to any of the excipients.

E3. For nilotinib, sorafenib, pazopanib, lapatinib and olaparib: Patient with hypokalemia (< Lower Limit of Normal) or known history of congenital long QT syndrome (QT interval prolongation).

E4. Prior malignancy or presence of any other active malignancy. Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.

E5. Patient who have had major surgery or trauma within 28 days prior to first dose of investigational product. Patient must have recovered from any effects of any major surgery.

E6. Patient with symptomatic or uncontrolled CNS metastatic involvement of his/her cancer, unless the patient have stable neurological function without evidence of CNS progression within 12 weeks prior to study entry and does not require treatment with enzyme-inducing anticonvulsants or steroids. Patients with a primitive tumor of the CNS are not eligible to IT and if one of the following conditions is fulfilled:

  • Alteration of cognitive functions impeding the patient's comprehension of study and the provision of informed consent by the patient himself/herself.
  • Need for supportive care treatment(s) interfering with study treatment.

E7. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment: radiation therapy (for olaparib : within 3 weeks or 5 half-lives of a drug whichever is longer), surgery or tumor embolization within 14 days prior to the first dose of study treatment OR immunotherapy within 28 days (except for IT : patient already treated with an immunotherapy are excluded) OR chemotherapy (for olaparib : within 3 weeks or 5 half-lives of a drug whichever is longer), biologic therapy, investigational therapy or hormonal therapy within 14 days or 5 half-lives of a drug (whichever is longer). Palliative radiotherapy is authorized only if the irradiated field does not include target lesions.

E8. Administration of any non-oncologic investigational agent within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment.

E9. For oral treatment : Patient with any condition that impairs their ability to swallow and retain tablets and may affect the absorption of the investigational product are excluded.

E10. For pazopanib: Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:

  • Active peptic ulcer disease
  • Known intraluminal metastatic lesion(s) with risk of bleeding
  • Inflammatory bowel disease or other gastrointestinal conditions with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.

E11. For pazopanib and IT: Evidence of active bleeding or bleeding diathesis. E12. For pazopanib: Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.

  • Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable.
  • Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed.
  • Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor infiltrations in the wall of the bronchi are allowed.

E13. For pazopanib: Recent hemoptysis.

E14. Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results. These conditions include but are not limited to:

  • Active clinically serious bacterial or fungal infection
  • History of uncontrolled or significant cardiac disease within the past 6 months: left ventricular ejection fraction (LVEF) < 50%, congestive cardiac failure, active ischemic heart disease, ventricular arrhythmia, myocardial infarction within 1 year, unstable angina pectoris, cardiac surgery. (except for Nilotinib, all patients with uncontrolled or significant cardiac disease are excluded)
  • Patients with cerebrovascular accident (including transient ischemic attack), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months are not eligible for pazopanib treatment group
  • Poorly controlled hypertension [for pazopanib: defined as systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg]
  • Severely impaired lung function
  • Active gastrointestinal tract ulceration
  • Acute or chronic uncontrolled liver disease, or severe renal disease
  • Uncontrolled diabetes
  • Known history of human immunodeficiency virus (HIV) infection, or active viral infection (hepatitis B virus (HBV), hepatitis C virus (HCV)) at the time of study entry and/or requiring anti-viral therapy, or chronic hepatitis B or C. Detection of hepatitis C RNA must be performed before inclusion of patients with a history of HCV infection: patients with a positive result are excluded.
  • History of organ allograft or patient taking immunosuppressive treatment.

E15. Patient unable or unwilling to discontinue use of prohibited medications for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.

E16. Pregnant or breastfeeding women. E17. Patients with any medical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or evaluations of the study results.

E18. Patient currently treated with drugs that could interfere with study drugs metabolism E19. Patients filling at least one of these criteria are excluded. (Specific to olaparib)

  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
  • Patients considered a poor medical risk due to a serious, uncontrolled seizures, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent myocardial infarction, unstable spinal cord compression , superior vena cava syndrome, extensive bilateral lung disease on High-resolution computed tomography (HRCT) scan.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation and whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable) are not allowed.
  • Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks.
  • Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
  • Patients eligible for olaparib (Lynparza®) in its approved indication: monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum based chemotherapy.
  • Patients with the following cancers: breast or stomach or ovarian or small cell lung cancers.
  • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).

E20. For IT: Patients filling at least one of these criteria are excluded.

  • Patients with lung or urothelial or head and neck cancers or CNS tumors or patients who fulfill conditions to receive one of the investigational therapy of the study
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of Durvalumab or Tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10mg/day of prednisone, or an equivalent corticosteroid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029001


Contacts
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Contact: Jean-Yves BLAY, MD +33478785126 jean-yves.blay@lyon.unicancer.fr
Contact: Olivier TREDAN, MD +33478782828 olivier.tredan@lyon.unicancer.fr

Locations
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France
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Antoine ITALIANO    +335 56 33 33 33    a.italiano@bordeaux.unicancer.fr   
Principal Investigator: Antoine ITALIANO         
Sub-Investigator: Maud TOULMONDE         
Sub-Investigator: Sophie COUSIN         
Sub-Investigator: Mathilde CABART         
Sub-Investigator: Guilhem ROUBAUD         
Sub-Investigator: Kevin BOURCIER         
Sub-Investigator: Yann GODBERT         
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Jean-Yves BLAY    +33478785126    jean-yves.blay@lyon.unicancer.fr   
Principal Investigator: Jean-Yves BLAY, MD         
Sub-Investigator: Virginie AVRILLON         
Sub-Investigator: Thomas BACHELOT         
Sub-Investigator: Christophe BERGERON         
Sub-Investigator: Pierre BIRON         
Sub-Investigator: Helen BOYLE         
Sub-Investigator: Philippe CASSIER         
Sub-Investigator: Patrick COMBEMALE         
Sub-Investigator: Maria CHELGHOUM         
Sub-Investigator: Françoise DESSEIGNE         
Sub-Investigator: Cécile FAURE-CONTER         
Sub-Investigator: Jérome FAYETTE         
Sub-Investigator: Aude FLECHON         
Sub-Investigator: Christelle DE LA FOUCHARDIERE         
Sub-Investigator: Didier FRAPPAZ         
Sub-Investigator: Pierre GUIBERT         
Sub-Investigator: Pierre-Etienne HEUDEL         
Sub-Investigator: Eve-Marie NEIDHARDT         
Sub-Investigator: Maurice PEROL         
Sub-Investigator: Isabelle RAY-COQUARD         
Sub-Investigator: Pierre SAINTIGNY         
Sub-Investigator: Olivier TREDAN         
Sub-Investigator: Stéphane DEPIL         
Sub-Investigator: Olfa DERBEL         
Sub-Investigator: Nathalie MARQUES         
Sub-Investigator: Philippe TOUSSAINT         
Sub-Investigator: Mehdi BRAHMI         
Sub-Investigator: Matthieu SARABI         
Sub-Investigator: Alice BONNEVILLE-LEVARD         
Sub-Investigator: Nadège CORRADINI         
Sub-Investigator: Louis DOUBLET         
Sub-Investigator: Armelle DUFRESNE         
Sub-Investigator: Lauriane EBERST         
Sub-Investigator: Sylvie NEGRIER         
Sub-Investigator: Katell MICHAUX         
Sub-Investigator: Anne-Sophie MICHALLET         
Sub-Investigator: Juliette REURE         
Sub-Investigator: Pauline ROCHEFORT         
Centre Hospitalier Lyon Sud Recruiting
Lyon, France, 69495
Contact: BENOIT YOU, Dr    04 78 86 43 22    benoit.you@chu-lyon.fr   
Principal Investigator: BENOIT YOU         
Sub-Investigator: Nathalie BONNIN         
Sub-Investigator: Marion CHAUVENET         
Sub-Investigator: Claire FALANDRY         
Sub-Investigator: Gilles FREYER         
Sub-Investigator: Olivia LE SAUX         
Sub-Investigator: Denis MAILLET         
Sub-Investigator: Julien PERON         
Sub-Investigator: Sophie TARTAS         
Sub-Investigator: Véronique TRILLET-LENOIR         
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Contact: François BERTUCCI    +334 91 22 35 37    bertuccif@ipc.unicancer.fr   
Principal Investigator: François BERTUCCI         
Sub-Investigator: Jean-Marc EXTRA         
Sub-Investigator: Anthony GONCALVES         
Sub-Investigator: Gwenaëlle GRAVIS-MESCAM         
Sub-Investigator: Anne MADROSZYK-FLANDIN         
Sub-Investigator: Jean-Luc RAOUL         
Sub-Investigator: Delphine PERROT         
Sub-Investigator: Magali PROVENSAL         
Sub-Investigator: Carole TARPIN         
Sub-Investigator: Frédéric VIRET         
Sub-Investigator: Louis TASSY         
Sub-Investigator: Maria Antonietta CAPPIELLO         
Sub-Investigator: Slimane DERMECHE         
Sub-Investigator: Simon LAUNAY         
Sub-Investigator: Frederique ROUSSEAU         
Sub-Investigator: Nicolas MEYER         
Sub-Investigator: Loïc MOUREY         
Sub-Investigator: Elisabeth MOYAL         
Sub-Investigator: Roxana Maria RADUT         
Sub-Investigator: Henri ROCHE         
Sub-Investigator: Thibaud VALENTIN         
Sub-Investigator: Sarah ZAHI         
Sub-Investigator: Marine GILABERT         
Sub-Investigator: Erika LOIR         
Sub-Investigator: Audrey MONNEUR         
Sub-Investigator: Pauline REIS         
Institut Curie Recruiting
Paris, France, 75248
Contact: Christophe LE TOURNEAU, MD    +33144324672    Christophe.letourneau@curie.fr   
Principal Investigator: Christophe LE TOURNEAU, MD         
Sub-Investigator: Philippe BEUZEBOC         
Sub-Investigator: François-Clément BIDARD         
Sub-Investigator: Bruno BUECHER         
Sub-Investigator: Paul-Henri COTTU         
Sub-Investigator: Catherine DANIEL         
Sub-Investigator: Véronique DIERAS         
Sub-Investigator: Valérie LAURENCE         
Sub-Investigator: Alain LIVARTOWSKI         
Sub-Investigator: Jean-Yves PIERGA         
Sub-Investigator: Marie ALT         
Sub-Investigator: Delphine LOIRAT         
Sub-Investigator: Marie-Paule SABLIN         
Sub-Investigator: Mustapha ZOUBIR         
Sub-Investigator: Francesco RICCI         
Sub-Investigator: Emanuela ROMANO         
Sub-Investigator: Olivier COLLARD         
Sub-Investigator: Edith BORCOMAN         
Sub-Investigator: Ségolène HESCOT         
Sub-Investigator: Nouritza TOROSSIAN         
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Contact: Carlos-Alberto GOMEZ-ROCA    05 31 15 51 01    Gomez-roca.carlos@iuct-oncopole.fr   
Principal Investigator: Carlos-Alberto GOMEZ-ROCA         
Sub-Investigator: Christine CHEVREAU         
Sub-Investigator: Ewa-Anna COTTURA         
Sub-Investigator: Florence DALENC         
Sub-Investigator: Jean-Pierre DELORD         
Sub-Investigator: Marion DESLANDRES         
Sub-Investigator: Laurence GLADIEFF         
Sub-Investigator: Eleonora MAIO D'ESPOSITO         
Sub-Investigator: Nicolas MEYER         
Sub-Investigator: Loïc MOUREY         
Sub-Investigator: Elisabeth MOYAL         
Sub-Investigator: Henri ROCHE         
Sub-Investigator: Thibaud VALENTIN         
Sub-Investigator: Iphigénie KORAKIS         
Sub-Investigator: Delphine LARRIEU-CIRON         
Sub-Investigator: Damien POUESSEL         
Sponsors and Collaborators
Centre Leon Berard
National Cancer Institute, France
Investigators
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Principal Investigator: Jean-Yves BLAY, MD Centre Leon Berard
Additional Information:
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02029001    
Other Study ID Numbers: ET12-081
2012-004510-34 ( EudraCT Number )
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: February 2021
Keywords provided by Centre Leon Berard:
Solid tumor
Recurrent/metastatic
Personalized medicine
Genomic alteration
Targeted therapy
Nilotinib
Everolimus
Sorafenib
Lapatinib
Pazopanib
Olaparib
Immunotherapy
Durvalumab
Tremelimumab
Additional relevant MeSH terms:
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Everolimus
Sorafenib
Durvalumab
Olaparib
Lapatinib
Tremelimumab
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Poly(ADP-ribose) Polymerase Inhibitors