Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size
Trial record 1 of 1 for:    NCT01905228
Previous Study | Return to List | Next Study

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 July 2016 by Incuron
Sponsor:
Information provided by (Responsible Party):
Incuron
ClinicalTrials.gov Identifier:
NCT01905228
First received: July 9, 2013
Last updated: July 5, 2016
Last verified: July 2016
History of Changes

July 9, 2013
July 5, 2016
July 2013
January 2017   (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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01905228 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
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 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
Intervention: Drug: CBL0137
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
Not Provided
January 2017   (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; 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.
Both
18 Years and older   (Adult, Senior)
No
Contact: Langdon L Miller, MD 716-849-6810 lmiller@cbiolabs.com
United States
 
NCT01905228
I137-101
No
Not Provided
Not Provided
Incuron
Incuron
Not Provided
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
Incuron
July 2016

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