BridgeMD
New treatment option for Malignant Solid Neoplasms
Official title Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment
ClinicalTrials.gov ID: NCT02029001
What this study is testing
What is Nilotinib (400 mg BID)?
Nilotinib (400 mg BID) is an investigational medicine, being studied as a potential treatment for malignant solid neoplasms.
Also referred to as Open cohort.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- I1. Male or female patient ≥ 18 years of age. I2. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced and...
- 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...
- For pazopanib: activated partial thromboplastin time (aPTT) ≤ 1.2x Upper limit of normal (ULN) and prothrombin time (PT) or international normalized...
You likely can't join if
- Patients eligible for this study must not meet any of the following criteria: E1. Previous treatment in advanced phase with an investigational...
- 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...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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; people receiving anticoagulant therapy are...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 in France 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Lyon, France
- Marseille, France
- Paris, France
- Strasbourg, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Lyon, France; Marseille, France; Paris, France; Strasbourg, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.