Trial record 1 of 1 for:    NCT01905228
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01905228
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : April 2, 2018
Information provided by (Responsible Party):

July 9, 2013
July 23, 2013
April 2, 2018
July 2013
February 2019   (Final data collection date for primary outcome measure)
To determine the maximally tolerated dose and recommended Phase 2 dose [ Time Frame: 30 days after last dose ]
Same as current
Complete list of historical versions of study NCT01905228 on Archive Site
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A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
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.
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.
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Solid Tumors
  • Glioblastoma
Drug: CBL0137
All doses are on Days 1, 8 and 15 of every 28 day cycle. Number of Cycles: 2 or until progression or unacceptable toxicity develops
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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2019
February 2019   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
Contact: Langdon L Miller, MD 716-849-6810
United States
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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
March 2018

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