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

Tracking Information
First Submitted Date ICMJE	July 9, 2013
First Posted Date ICMJE	July 23, 2013
Last Update Posted Date	April 2, 2018
Study Start Date ICMJE	July 2013
Estimated Primary Completion Date	February 2019 (Final data collection date for primary outcome measure)
Current 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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01905228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Solid Tumors; Glioblastoma
Intervention ICMJE	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
Study Arms	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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: March 29, 2018)	132
Original Estimated Enrollment ICMJE; (submitted: July 18, 2013)	48
Estimated Study Completion Date	November 2019
Estimated Primary Completion Date	February 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; 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	15 Years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Langdon L Miller, MD 716-849-6810 lmiller@cbiolabs.com
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	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	March 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP