A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm (NCT01905228) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
United States83 participantsStarted 2013-07
Plain-language summary
This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 li…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Timeframe: At the end of Cycle 1 (each cycle is 28 days)