Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01905228 : A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have histological or cytological evidence of a solid neoplasm

- Patients enrolled in the expansion cohort must have at least one measureable lesion as
defined by the RECIST 1.1 criteria

- Patients must:

- have metastatic or unresectable advanced solid tumors that have recurred or
progressed following standard therapy or

- no longer be candidates for standard therapy or

- have tumors for which there is no standard therapy

- Patients must be ambulatory and have an ECOG Performance Score of 0 or 1;

- Patients or their legal representative must be able to provide written informed
consent;

- Patients must have adequate bone marrow reserve as evidenced by:

- White Blood Cell Count (WBC) > 3,000/µL

- Absolute Neutrophil Count (ANC) > 1,500/µL

- Platelet count (PLT) > 75,000/µL

- Hemoglobin (HGB) > 8.0 gm/dL (patients may be transfused to achieve this HGB
level);

- Patients must have adequate hepatic function as evidenced by:

- Serum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X
the ULN for patients with known hepatic metastases)

- Serum bilirubin < 1.5 x the ULN for the reference lab;

Exclusion Criteria:

- Patients with active infection or with a fever > 38.50 C within 3 days of the first
scheduled day of dosing;

- Patients with primary CNS tumors or symptomatic CNS metastases who have not undergone
surgery and/or radiotherapy and/or who are not neurologically stable;

- Patients with known hypersensitivity to any of the components of CBL0137;

- Patients who are receiving concurrent investigational therapy; for patients who have
recently received investigational therapy, 5 half-lives must have elapsed between the
last dose of investigational drug and the first dose of CBL0137. If the half-live is
unknown, 4 weeks must have elapsed between the last dose of investigational drug and
the first dose of CBL0137 (investigational therapy is defined as treatment for which
there is currently no regulatory authority approved indication in the United States);

- Males with mean QTcF values of > 450 msec and females with QTcF values of > 470 msec
following 3 ECGs conducted 5 minutes apart from each other; patients who are known to
have congenital prolonged QT syndromes; or patients who are on medications known to
cause prolonged QT intervals on ECG;

Please speak with the PI for the complete Inclusion/Exclusion listing.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01905228      |      Link to official Clinicaltrials.gov listing
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