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Trial record 1 of 1 for:
NCT01905228
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
This study is currently recruiting participants.
Verified January 2017 by Incuron
Sponsor:
Incuron
Information provided by (Responsible Party):
Incuron
ClinicalTrials.gov Identifier:
NCT01905228
First received: July 9, 2013
Last updated: March 17, 2017
Last verified: January 2017
| Tracking Information | ||||||||||
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| First Received Date ICMJE | July 9, 2013 | |||||||||
| Last Updated Date | March 17, 2017 | |||||||||
| Start Date ICMJE | July 2013 | |||||||||
| Estimated Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Condition ICMJE | Solid Tumors | |||||||||
| 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 |
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| Study Arms | Experimental: CBL0137
Intervention: Drug: CBL0137 |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE | 84 | |||||||||
| Estimated Completion Date | October 2018 | |||||||||
| Estimated Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Please speak with the PI for the complete Inclusion/Exclusion listing. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE |
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| 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 |
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| PRS Account | Incuron | |||||||||
| Verification Date | January 2017 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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