Clinical Trials /

A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm

NCT01905228

Description:

The primary objective of the study is to determine the maximally tolerated dose and recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with metastatic or unresectable advanced solid malignancies.

Related Conditions:
  • Solid Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
  • Official Title: A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm

Clinical Trial IDs

  • ORG STUDY ID: I137-101
  • NCT ID: NCT01905228

Conditions

  • Solid Tumors
  • Glioblastoma

Interventions

DrugSynonymsArms
CBL0137CBL0137

Purpose

The primary objective of the study is to determine the maximally tolerated dose and recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with metastatic or unresectable advanced solid malignancies.

Detailed Description

      Patients must have documented recurrent or refractory solid tumors; patients enrolled in the
      dose-expansion part of the trial must have least one lesion that may qualify as a target
      lesion based on the RECIST 1.1 criteria. Following the provision of signed informed consent,
      patients will be screened for entry into the study. Screening numbers will be assigned by the
      site. Patients who do not meet entry criteria will not have their screening data entered into
      the database.
    

Trial Arms

NameTypeDescriptionInterventions
CBL0137ExperimentalDose Level 9: 150 mg/m2, IV Dose Level 10: 180 mg/m2, IV Dose Level 11: 240 mg/m2, IV Dose Level 12: 320 mg/m2, IV Dose Level 13: 400 mg/m2, IV Dose Level 14: 540 mg/m2, IV Dose Level 15: 700 mg/m2, IV Dose Level 16: 920 mg/m2, IV Dose Level 17: 1200 mg/m2, IV Dose Level 18: 1600 mg/m2, IV Dose Level 19: 2100 mg/m2, IV Dose Level 20: 2700 mg/m2, IV
  • CBL0137

Eligibility Criteria

        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;

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:15 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To determine the maximally tolerated dose and recommended Phase 2 dose
Time Frame:30 days after last dose
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incuron

Trial Keywords

  • Metastatic Advance Solid Neoplasms
  • Unresectable Advance Solid Neoplasms

Last Updated

March 29, 2018