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Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER) | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)

An Open-label, Uncontrolled, Single Arm Phase II Trial of Buparlisib in Patients With Metastatic Melanoma With Brain Metastases Not Eligible for Surgery or Radiosurgery

NCT02452294•University Hospital Tuebingen

View on ClinicalTrials.gov

Summary

The study will enrol adult female and male patients with BRAF wild-type melanoma and brain metastases who are not eligible for surgery or radiosurgery and failed prior therapy with ipilimumab, and patients with BRAF V600 mutation-positive melanoma and brain metastases who are not eligible for surgery or radiosurgery and who failed prior therapy with a BRAF inhibitor.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements.
•2. Patient has adequate bone marrow and organ function as defined by the following laboratory values; (Clinical labs - performed within 14 days prior to enrolment)
•Hematology
•1. Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L
•2. Platelet count ≥ 100 x 109/L (For patients with haematologic malignancies involving the bone marrow, platelet count \> 75 x 109/L)
•3. Haemoglobin ≥ 9.0 g/dL Coagulation
•4. INR ≤ 1.5
•Biochemistry e. Potassium and calcium (corrected for albumin), within normal limits for the institution, or ≤ Grade 1 if judged not clinically significant by the investigator f. Serum creatinine ≤ 1.5 x ULN and/or creatinine clearance \> 50% LLN (Lower Limit of Normal) g. Total Serum bilirubin ≤ ULN (or \<1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from CBC count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis h. AST (SGOT) and ALT (SGPT) below or equal upper limit of normal range or (≤ 3.0 x ULN if liver metastases are present) i. Fasting plasma glucose (FPG) ≤ 120mg/dL or ≤ 6.7 mmol/L j. HbA1c ≤ 8%
•3. Patient is able to swallow and retain oral medication
•4. Patient must be at least 18 years old
+30 more criteria

Exclusion Criteria

•1. Patient has a known hypersensitivity to any of the excipients of buparlisib
•2. Patient who has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered to Grade 1 or better from related side effects of such therapy (except alopecia)
•3. Patient has not recovered to Grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
•4. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects
•5. Patient is currently receiving increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent;
•1. The following uses of corticosteroids are permitted: single doses; e.g. with standard premedication for taxanes; topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
•2. Patient taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, rufinamide carbamazepine, oxcarbazepine, eslicarbazepine, felbamate, and topiramate (only when daily dose exceeds 200 mg). Participant must be off any EIAEDs for at least two weeks prior to starting study
•3. Requirement of more than 4 mg dexamethasone daily
•6. Patient is being treated at start of study treatment with any of the following drugs:
•1. Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A including herbal medications.
+18 more criteria

Locations (2)

Department of Dermatology, University Hopsital

Dresden, Germany

Department of Dermatology, University Hospital

Tübingen, Germany

Key Dates

Start Date

July 1, 2015

Primary Completion Date

December 1, 2017

Completion Date

July 1, 2018

Last Updated

May 3, 2017

Enrollment

ESTIMATED participants

Conditions

Malignant MelanomaMetastases

Interventions

Buparlisib

DRUG

Contacts

Claus Garbe, MD

CONTACT

++49 7071 29 claus.garbe@med.uni-tuebingen.de

Thomas K Eigentler, MD

CONTACT

++49 7071 29 thomas.eigentler@med.uni-tuebingen.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)

Inclusion Criteria

Exclusion Criteria

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