Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
NCT ID: NCT07243470
Last Updated: 2025-11-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-11-04
Study Completion Date
2030-10-31
Brief Summary
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This clinical trial is a 2-phase trial designed to evaluate the safety of tarlatamab in combination with a fixed dose of metronomic temozolomide in adolescents and adults with CNS tumors (stratified into two age-based cohorts), and to assess the clinical activity of this therapeutic strategy in three parallel, histology-defined cohorts (IDH-mutant glioma, other gliomas, and other CNS tumors). A pre-screening to detect DLL3 expression by IHC on archival tumor sample must be performed before the therapeutic part. Only patients with DLL3 positive tumor on IHC can be enrolled in the therapeutic part. This pre-screening must be optimally performed during the ongoing treatment line i.e. before documented progression to not delay treatment starts at time of progression. Tumor samples (surgery or biopsy specimen) will be sent to a central lab for IHC testing.
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Detailed Description
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Conditions
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Glioma
CNS Tumor, Adult
CNS Tumor, Childhood
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SEQUENTIAL
The study consists of 2 parts:
A Phase I (safety run-in) part to confirm the safety of tarlatamab single agent followed by combination with a fixed dose of metronomic temozolomide (TMZ).
Patients start at DL1 with a test dose of tarlatamab 1 mg (C1D1), followed by 10 mg on D8 and D15 of cycle 1 without TMZ. From cycle 2 onward, they receive 10 mg of tarlatamab on D1 and D15 of each 4-week cycle in combination with TMZ.
Adult safety run in cohort will be opened first, then adolescent safety run in cohort will be evaluated only once the adult safety run in is cleared. A one-week delay period between each pediatric enrolment will be required during pediatric safety run in.
A Phase II part to assess the clinical activity of the proposed strategy in 3 independent and parallel cohorts: IDH-mutant high-grade glioma, other high-grade glioma, and other high-grade CNS tumors. Enrolment in phase II will be possible only after validation of safety run in in adults then in paediatric patients.
A Phase I (safety run-in) part to confirm the safety of tarlatamab single agent followed by combination with a fixed dose of metronomic temozolomide (TMZ).
Patients start at DL1 with a test dose of tarlatamab 1 mg (C1D1), followed by 10 mg on D8 and D15 of cycle 1 without TMZ. From cycle 2 onward, they receive 10 mg of tarlatamab on D1 and D15 of each 4-week cycle in combination with TMZ.
Adult safety run in cohort will be opened first, then adolescent safety run in cohort will be evaluated only once the adult safety run in is cleared. A one-week delay period between each pediatric enrolment will be required during pediatric safety run in.
A Phase II part to assess the clinical activity of the proposed strategy in 3 independent and parallel cohorts: IDH-mutant high-grade glioma, other high-grade glioma, and other high-grade CNS tumors. Enrolment in phase II will be possible only after validation of safety run in in adults then in paediatric patients.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Patients with IDH-mutant glioma
Patients must have histologically confirmed diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma or other high-grade CNS tumors.
Group Type
EXPERIMENTAL
Tarlatamab
Intervention Type
DRUG
At the starting dose (DL1): All patients will receive a step dose (1 mg) on C1D1 administered as a 60-minute intravenous (IV) infusion then 10mg at C1D8 and C1D15 of tarlatamab single agent (no temozolomide administered during cycle 1) then tarlatamab at 10mg every D1 \& D15 of each 4-week cycle thereafter in combination with temozolomide from C2D1.
At DL-1: a cycle period will be 6 weeks with tarlatamab administration every 3 weeks after Cycle 1.
Temozolomide (TMZ)
Intervention Type
DRUG
At DL1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
At DL-1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
Patients with other glioma
Patients must have histologically confirmed diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma or other high-grade CNS tumors.
Group Type
EXPERIMENTAL
Tarlatamab
Intervention Type
DRUG
At the starting dose (DL1): All patients will receive a step dose (1 mg) on C1D1 administered as a 60-minute intravenous (IV) infusion then 10mg at C1D8 and C1D15 of tarlatamab single agent (no temozolomide administered during cycle 1) then tarlatamab at 10mg every D1 \& D15 of each 4-week cycle thereafter in combination with temozolomide from C2D1.
At DL-1: a cycle period will be 6 weeks with tarlatamab administration every 3 weeks after Cycle 1.
Temozolomide (TMZ)
Intervention Type
DRUG
At DL1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
At DL-1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
Patients with other CNS tumors
Patients must have histologically confirmed diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma or other high-grade CNS tumors.
Group Type
EXPERIMENTAL
Tarlatamab
Intervention Type
DRUG
At the starting dose (DL1): All patients will receive a step dose (1 mg) on C1D1 administered as a 60-minute intravenous (IV) infusion then 10mg at C1D8 and C1D15 of tarlatamab single agent (no temozolomide administered during cycle 1) then tarlatamab at 10mg every D1 \& D15 of each 4-week cycle thereafter in combination with temozolomide from C2D1.
At DL-1: a cycle period will be 6 weeks with tarlatamab administration every 3 weeks after Cycle 1.
Temozolomide (TMZ)
Intervention Type
DRUG
At DL1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
At DL-1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
Interventions
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Tarlatamab
At the starting dose (DL1): All patients will receive a step dose (1 mg) on C1D1 administered as a 60-minute intravenous (IV) infusion then 10mg at C1D8 and C1D15 of tarlatamab single agent (no temozolomide administered during cycle 1) then tarlatamab at 10mg every D1 \& D15 of each 4-week cycle thereafter in combination with temozolomide from C2D1.
At DL-1: a cycle period will be 6 weeks with tarlatamab administration every 3 weeks after Cycle 1.
Intervention Type
DRUG
Temozolomide (TMZ)
At DL1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
At DL-1 : Metronomic temozolomide will not be administered during the first cycle. It will be administered from the first day of the second cycle, at a dose of 50 mg/m²/day, continuously.
Intervention Type
DRUG
Other Intervention Names
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Temodal
Eligibility Criteria
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Inclusion Criteria
I1. Patients aged ≥ 12 years old at time of inform consent signature.
I2. Histologically proven diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma, or other high-grade CNS tumors.
I3. Tumors expressing DLL3 based on IHC staining performed on archival tumor sample i.e. at least 1+ on IHC \[patient with no tumor expression of DLL3 are not eligible\].
Note- This pre-screening by IHC should be optimally initiated during an ongoing line of treatment i.e. before documented progression. The ICF1 must be signed before to initiate this pre-screening.
I4. Confirmed progressive or refractory disease after at least one line of standard therapy containing radiotherapy and for which no further effective standard therapy exists.
I5. Evaluable or measurable disease as per iRANO criteria.
I6. Performance status (See Appendix 01):
1. Karnofsky PS for pediatric patients ≥16 years of age ≥ 70%;
2. Lansky PS for patients between 12 and 15y: ≥ 70%;
3. PS ECOG for adult patients: 0 or 1.
I7. Life expectancy ≥ 3 months.
I8. Adequate end organ function according to laboratory values defined below :
Hematologic criteria :
* Peripheral absolute neutrophil count (ANC) ≥1.5 G/L (without growth factor support within 7 days)
* Platelet count ≥ 100 G/L (unsupported for \> 7 days)
* Hemoglobin ≥ 9.0 g/dL (unsupported for \> 7 days)
Renal and hepatic function :
* Creatinine
* Adult patient: Creatinine clearance as per CKD-EPI \> 30 mL/min/1.73 m²
* Pediatric patients: Creatinine \<1.5 ULN for age or an estimated glomerular filtration rate (GFR) \> 60 mL/min/1.73m2 GFR based on the Schwartz equation (Mian and Schwartz 2017) or as per institutional guidelines
* Total bilirubin ≤1.5 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome)
* Alanine aminotransferase (ALAT) ≤ 3 x ULN; aspartate aminotransferase (ASAT) ≤ 3 x ULN Coagulation function : Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN. Patients on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enrol after discussion with the Sponsor.
I9. Adequate cardiac function defined by Left ventricular ejection fraction (LVEF) ≥50% at baseline.
I10. Adequate pulmonary function as per investigator judgment and no clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (e.g, PleurX) are allowed.
I11. Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of tumor tissue (resection or biopsy, archival) with an associated pathology report must be available. This tumor sample must meet the following quality/quantity control criteria: ≥30 % of tumor cells.
I12. Patients must have discontinued all previous anti-cancer treatments (approved or investigational) for CNS treatment with respect of wash-out period at time of C1D1 as shown below:
* Cytotoxic and myelosuppressive chemotherapy : ≥21 days (or ≥42 days if prior nitrosourea)
* Metronomic chemotherapy regimen : ≥21 days or ≥5 half-lives of the treatment with the longest half-life (whichever is shorter)
* Targeted agent : ≥21 days or ≥5 half-lives (whichever is shorter)
* Cellular therapy : ≥42 days for any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells) agent
* Antibody therapy : ≥21 days after the last infusion except for bevacizumab for which a wash out period of 3 months is requested
* Radiotherapy :
* ≥14 days since small port radiation therapy (i.e. local palliative)
* ≥84 days since large-field radiation therapy (i.e. TBI, craniospinal, whole abdominal, total lung, ≥50% or greater pelvic radiation, ≥50% marrow space)
* ≥42 days for other substantial bone marrow radiation
* Surgery : Major surgery ≥ 21 days. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before C1D1
I13. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior C1D1 and must agree to use highly effective contraceptive measures starting with the Screening Visit through 6 months after the last dose of study drugs and to not breastfeed during this period. Highly effective contraception is defined in Appendix 02.
I14. Sexually active male must agree to use adequate and appropriate contraception while on study drugs and for 6 months after stopping the study drugs.
I15. Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry and written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
I16. Covered by a medical insurance.
E16.Arterial thrombosis or a history of pulmonary embolism who need anticoagulants.
E17.Evidence of interstitial lung disease or active, non-infectious pneumonitis.
E18.Recurrent pneumonitis (grade 2 or higher) or grade≥3 immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
E19. Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.
E20. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).
E21. Documentation of:
▪ Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study.
Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.
* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or
* HIV infection
E22. Prior organ or bone marrow transplant
E23. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
E24. Pregnant or breastfeeding women.
I2. Histologically proven diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma, or other high-grade CNS tumors.
I3. Tumors expressing DLL3 based on IHC staining performed on archival tumor sample i.e. at least 1+ on IHC \[patient with no tumor expression of DLL3 are not eligible\].
Note- This pre-screening by IHC should be optimally initiated during an ongoing line of treatment i.e. before documented progression. The ICF1 must be signed before to initiate this pre-screening.
I4. Confirmed progressive or refractory disease after at least one line of standard therapy containing radiotherapy and for which no further effective standard therapy exists.
I5. Evaluable or measurable disease as per iRANO criteria.
I6. Performance status (See Appendix 01):
1. Karnofsky PS for pediatric patients ≥16 years of age ≥ 70%;
2. Lansky PS for patients between 12 and 15y: ≥ 70%;
3. PS ECOG for adult patients: 0 or 1.
I7. Life expectancy ≥ 3 months.
I8. Adequate end organ function according to laboratory values defined below :
Hematologic criteria :
* Peripheral absolute neutrophil count (ANC) ≥1.5 G/L (without growth factor support within 7 days)
* Platelet count ≥ 100 G/L (unsupported for \> 7 days)
* Hemoglobin ≥ 9.0 g/dL (unsupported for \> 7 days)
Renal and hepatic function :
* Creatinine
* Adult patient: Creatinine clearance as per CKD-EPI \> 30 mL/min/1.73 m²
* Pediatric patients: Creatinine \<1.5 ULN for age or an estimated glomerular filtration rate (GFR) \> 60 mL/min/1.73m2 GFR based on the Schwartz equation (Mian and Schwartz 2017) or as per institutional guidelines
* Total bilirubin ≤1.5 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome)
* Alanine aminotransferase (ALAT) ≤ 3 x ULN; aspartate aminotransferase (ASAT) ≤ 3 x ULN Coagulation function : Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN. Patients on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enrol after discussion with the Sponsor.
I9. Adequate cardiac function defined by Left ventricular ejection fraction (LVEF) ≥50% at baseline.
I10. Adequate pulmonary function as per investigator judgment and no clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (e.g, PleurX) are allowed.
I11. Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of tumor tissue (resection or biopsy, archival) with an associated pathology report must be available. This tumor sample must meet the following quality/quantity control criteria: ≥30 % of tumor cells.
I12. Patients must have discontinued all previous anti-cancer treatments (approved or investigational) for CNS treatment with respect of wash-out period at time of C1D1 as shown below:
* Cytotoxic and myelosuppressive chemotherapy : ≥21 days (or ≥42 days if prior nitrosourea)
* Metronomic chemotherapy regimen : ≥21 days or ≥5 half-lives of the treatment with the longest half-life (whichever is shorter)
* Targeted agent : ≥21 days or ≥5 half-lives (whichever is shorter)
* Cellular therapy : ≥42 days for any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells) agent
* Antibody therapy : ≥21 days after the last infusion except for bevacizumab for which a wash out period of 3 months is requested
* Radiotherapy :
* ≥14 days since small port radiation therapy (i.e. local palliative)
* ≥84 days since large-field radiation therapy (i.e. TBI, craniospinal, whole abdominal, total lung, ≥50% or greater pelvic radiation, ≥50% marrow space)
* ≥42 days for other substantial bone marrow radiation
* Surgery : Major surgery ≥ 21 days. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before C1D1
I13. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior C1D1 and must agree to use highly effective contraceptive measures starting with the Screening Visit through 6 months after the last dose of study drugs and to not breastfeed during this period. Highly effective contraception is defined in Appendix 02.
I14. Sexually active male must agree to use adequate and appropriate contraception while on study drugs and for 6 months after stopping the study drugs.
I15. Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry and written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
I16. Covered by a medical insurance.
E16.Arterial thrombosis or a history of pulmonary embolism who need anticoagulants.
E17.Evidence of interstitial lung disease or active, non-infectious pneumonitis.
E18.Recurrent pneumonitis (grade 2 or higher) or grade≥3 immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
E19. Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.
E20. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).
E21. Documentation of:
▪ Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study.
Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.
* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or
* HIV infection
E22. Prior organ or bone marrow transplant
E23. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
E24. Pregnant or breastfeeding women.
Exclusion Criteria
E1. Diagnosis of non-CNS tumor.
E2. Diagnosis of diffuse intrinsic pontine glioma.
E3. Current treatment with bevacizumab.
E5. Neurologically unstable or require increasing doses of corticosteroids during the 7 days before C1D1 or local CNS-directed therapy to control their CNS disease. Note: Patients on low doses of corticosteroids (\< 0.25mg/kg/d of prednisolone or equivalent) during the 7 days prior to receiving study drugs are eligible.
E6. Evidence of Grade \> 1 recent CNS hemorrhage on the baseline MRI scan.
E7. Bulky tumor on imaging defined as:
i. Tumor with any evidence of uncial herniation or severe midline shift ii. Tumor with diameter of \> 6 cm in one dimension on contrast-enhanced MRI iii. Tumor that in the opinion of the investigator shows significant mass effect.
E8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
E9. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to C1D1.
E10. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 6 months of C1D1).
E11. Other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.
E12.History of hypophysitis or pituitary dysfunction.
E13.History of severe allergic or other hypersensitivity reactions to
* chimeric or humanized antibodies or fusion proteins,
* biopharmaceuticals produced in Chinese hamster ovary cells,
* or any component of the tarlatamab formulation.
E14.Known hypersensitivity to any study drug or component of the formulation or to dacarbazine or TMZ.
E2. Diagnosis of diffuse intrinsic pontine glioma.
E3. Current treatment with bevacizumab.
E5. Neurologically unstable or require increasing doses of corticosteroids during the 7 days before C1D1 or local CNS-directed therapy to control their CNS disease. Note: Patients on low doses of corticosteroids (\< 0.25mg/kg/d of prednisolone or equivalent) during the 7 days prior to receiving study drugs are eligible.
E6. Evidence of Grade \> 1 recent CNS hemorrhage on the baseline MRI scan.
E7. Bulky tumor on imaging defined as:
i. Tumor with any evidence of uncial herniation or severe midline shift ii. Tumor with diameter of \> 6 cm in one dimension on contrast-enhanced MRI iii. Tumor that in the opinion of the investigator shows significant mass effect.
E8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
E9. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to C1D1.
E10. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 6 months of C1D1).
E11. Other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.
E12.History of hypophysitis or pituitary dysfunction.
E13.History of severe allergic or other hypersensitivity reactions to
* chimeric or humanized antibodies or fusion proteins,
* biopharmaceuticals produced in Chinese hamster ovary cells,
* or any component of the tarlatamab formulation.
E14.Known hypersensitivity to any study drug or component of the formulation or to dacarbazine or TMZ.
Minimum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Amgen
INDUSTRY
Sponsor Role
collaborator
National Cancer Institute, France
OTHER_GOV
Sponsor Role
collaborator
Centre Leon Berard
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Institut de Cancérologie de l'Ouest
Angers, , France
Site Status
NOT_YET_RECRUITING
Hôpital Universitaire d'Angers
Angers, , France
Site Status
NOT_YET_RECRUITING
CHU de Bordeaux
Bordeaux, , France
Site Status
NOT_YET_RECRUITING
Hôpital Saint-André
Bordeaux, , France
Site Status
NOT_YET_RECRUITING
Hôpital Neurologique Pierre Wertheimer
Bron, , France
Site Status
NOT_YET_RECRUITING
Centre Oscar Lambret
Lille, , France
Site Status
NOT_YET_RECRUITING
Centre Léon Bérard
Lyon, , France
Site Status
RECRUITING
Hôpital de la Timone
Marseille, , France
Site Status
NOT_YET_RECRUITING
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
Paris, , France
Site Status
NOT_YET_RECRUITING
IUCT - Claudius Regaud
Toulouse, , France
Site Status
NOT_YET_RECRUITING
Institut Gustave Roussy
Villejuif, , France
Site Status
NOT_YET_RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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Farago A.et al. dynamics of DLL3 and ASCL1 expression in SCLC over disease course. J Thorac Oncol. 2018; 13: S970-S971
Reference Type
RESULT
Longton EB. Excision of the trapezium using a palmar approach. J R Coll Surg Edinb. 1972 Nov;17(6):390-1. No abstract available.
Reference Type
RESULT
Hu B, Nandhu MS, Sim H, Agudelo-Garcia PA, Saldivar JC, Dolan CE, Mora ME, Nuovo GJ, Cole SE, Viapiano MS. Fibulin-3 promotes glioma growth and resistance through a novel paracrine regulation of Notch signaling. Cancer Res. 2012 Aug 1;72(15):3873-85. doi: 10.1158/0008-5472.CAN-12-1060. Epub 2012 Jun 4.
Reference Type
RESULT
Baruchel S, Diezi M, Hargrave D, Stempak D, Gammon J, Moghrabi A, Coppes MJ, Fernandez CV, Bouffet E. Safety and pharmacokinetics of temozolomide using a dose-escalation, metronomic schedule in recurrent paediatric brain tumours. Eur J Cancer. 2006 Sep;42(14):2335-42. doi: 10.1016/j.ejca.2006.03.023. Epub 2006 Aug 8.
Reference Type
RESULT
Newlands ES, Stevens MF, Wedge SR, Wheelhouse RT, Brock C. Temozolomide: a review of its discovery, chemical properties, pre-clinical development and clinical trials. Cancer Treat Rev. 1997 Jan;23(1):35-61. doi: 10.1016/s0305-7372(97)90019-0. No abstract available.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-510568-11-00
Identifier Type: CTIS
Identifier Source: secondary_id
ET23-040
Identifier Type: -
Identifier Source: org_study_id
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