- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905228
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Cleveland, Ohio, United States, 44106
- University Hospital of Cleveland
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Texas
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San Antonio, Texas, United States, 78229
- CTRC at The University of Texas Healh Science Center at San Antonio
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At the end of Cycle 1 (each cycle is 28 days)
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I137-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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