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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01905228
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : December 10, 2020
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE July 9, 2013
First Posted Date  ICMJE July 23, 2013
Last Update Posted Date December 10, 2020
Study Start Date  ICMJE July 2013
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
MTD is defined as dose level at which ≥6 participants have been treated and which is associated with a first-cycle DLT in ≤17% of the participants. Selection of RP2D from within the tolerated dose range will be based on evaluation of short- and long-term safety information together with findings relating to compliance, pharmacokinetics, pharmacodynamics and antitumor activity.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
To determine the maximally tolerated dose and recommended Phase 2 dose [ Time Frame: 30 days after last dose ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
Official Title  ICMJE A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
Brief Summary This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.
Detailed Description The primary objective of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CBL0137. The secondary objectives are to describe the dose-limiting toxicity (DLT) and adverse event profile of CBL0137, to describe the pharmacokinetic profile of CBL0137, to document any objective responses to CBL0137. This is a study of CBL0137 with a standard "3+3" design. Escalation will proceed to the MTD based on DLT in the 1st cycle in 1 of 6 participants in a cohort.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Glioblastoma
Intervention  ICMJE Drug: CBL0137

All doses are administered intravenously on Days 1, 8 and 15 of every 28 day cycle.

Number of Cycles: 2 or until progression or unacceptable toxicity develops

Other Name: Curaxin
Study Arms  ICMJE Experimental: CBL0137
  • Dose 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
Intervention: Drug: CBL0137
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 for patients with systemic tumors or the RANO criteria for patients with gliomas;
  • Patients with a systemic tumor 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 with a glioma must:

    • have Grade III (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma) disease, Grade IV (glioblastoma) disease, or diffuse intrinsic pontine glioma (DIPG) and;
    • have received prior therapy including radiation and drug therapy and;
    • have documented recurrent disease as defined in the RANO criteria;
  • 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 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 anticancer therapy;
  • Patients receiving enzyme-inducing antiepileptic agents within 14 days prior to the start of study 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01905228
Other Study ID Numbers  ICMJE I137-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incuron
Study Sponsor  ICMJE Incuron
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Sarantopoulos, MD The University of Texas Health Science Center at San Antonio
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institue
Principal Investigator: Afshin Dowlati, MD University Hospital of Cleveland
Principal Investigator: Manmeet Ahluwalia, MD The Cleveland Clinic
PRS Account Incuron
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP