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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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Incuron
Information provided by (Responsible Party):
Incuron Identifier:
First received: July 9, 2013
Last updated: March 17, 2017
Last verified: January 2017
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.

Condition Intervention Phase
Solid Tumors Drug: CBL0137 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm

Further study details as provided by Incuron:

Primary Outcome Measures:
  • To determine the maximally tolerated dose and recommended Phase 2 dose [ Time Frame: 30 days after last dose ]

Estimated Enrollment: 84
Study Start Date: July 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBL0137
  • Dose Level 1: 10 mg/m2, IV
  • Dose Level 2: 20 mg/m2, IV
  • Dose Level 3: 30 mg/m2, IV
  • Dose Level 4: 40 mg/m2, IV
  • Dose Level 5: 60 mg/m2, IV
  • Dose Level 6: 80 mg/m2, IV
  • Dose Level 7: 100 mg/m2, IV
  • Dose Level 8: 120 mg/m2, IV
  • 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
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01905228

Contact: Langdon L Miller, MD 716-849-6810

United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Renuka V. Iyer, MD   
Principal Investigator: Renuka V. Iyer, MD         
United States, Ohio
University Hospital of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Afshin Dowlati, MD    216-844-5181   
Principal Investigator: Afshin Dowlati, MD         
United States, Texas
CTRC at The University of Texas Healh Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Devalingam Mahalingam, MD   
Principal Investigator: Devalingam Mahalingam, MD, PhD         
Sponsors and Collaborators
Principal Investigator: Devalingam Mahalingam, MD The University of Texas Health Science Center at San Antonio
Principal Investigator: Wen W Ma, MD Roswell Park Cancer Institue
Principal Investigator: Neelesh Sharma, MD University Hospital of Cleveland
  More Information

Responsible Party: Incuron Identifier: NCT01905228     History of Changes
Other Study ID Numbers: I137-101
Study First Received: July 9, 2013
Last Updated: March 17, 2017

Keywords provided by Incuron:
Metastatic Advance Solid Neoplasms
Unresectable Advance Solid Neoplasms

Additional relevant MeSH terms:
Neoplasms processed this record on August 18, 2017