Solid TumorsPhase 1NCT01905228
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
A Phase 1 study testing CBL0137 in people with Solid Tumors and Glioblastoma, run by Incuron at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Solid Tumors, Glioblastoma
- What is being tested?
- CBL0137
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2013to Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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;
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University Hospital of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
CTRC at The University of Texas Healh Science Center at San Antonio
San Antonio, Texas, 78229
About this study
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.
Read the detailed description
The primary objective of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CBL0137. The secondary objectives are to describe the dose-limiting toxicity (DLT) and adverse event profile of CBL0137, to describe the pharmacokinetic profile of CBL0137, to document any objective responses to CBL0137. This is a study of CBL0137 with a standard "3+3" design. Escalation will proceed to the MTD based on DLT in the 1st cycle in 1 of 6 participants in a cohort.
- Conditions
- Solid Tumors, Glioblastoma
- Being tested
- CBL0137
- Keywords
- Metastatic Advance Solid Neoplasms, Unresectable Advance Solid Neoplasms
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL0137Drug
Also called Curaxin
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
| Study group | Role | What they receive |
|---|---|---|
| CBL0137 | Experimental | * 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 Receives: Drug: CBL0137 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
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.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incuron
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Sarantopoulos, MD, Principal investigator, The University of Texas Health Science Center at San AntonioRenuka Iyer, MD, Principal investigator, Roswell Park Cancer InstitueAfshin Dowlati, MD, Principal investigator, University Hospital of ClevelandManmeet Ahluwalia, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905228
- Sponsor's protocol ID
- I137-101
- Status last verified
- Dec 2020
- First submitted
- 9 Jul 2013
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
- ClinicalTrials.gov ID
- NCT01905228
- Acronym / sponsor ID
- I137-101
- Conditions
- Solid Tumors, Glioblastoma
- Keywords
- Metastatic Advance Solid Neoplasms, Unresectable Advance Solid Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- IncuronIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CBL0137. The secondary objectives are to describe the dose-limiting toxicity (DLT) and adverse event profile of CBL0137, to describe the pharmacokinetic profile of CBL0137, to document any objective responses to CBL0137. This is a study of CBL0137 with a standard "3+3" design. Escalation will proceed to the MTD based on DLT in the 1st cycle in 1 of 6 participants in a cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBL0137 | Experimental | Drug: 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- Patients with a glioma must:
- Patients must be ambulatory and have an ECOG Performance Score of 0 or 1;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBL0137Also: CuraxinAll 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 | Drug | CBL0137 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sarantopoulos, MD principal investigator
The University of Texas Health Science Center at San Antonio
Renuka Iyer, MD principal investigator
Roswell Park Cancer Institue
Afshin Dowlati, MD principal investigator
University Hospital of Cleveland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBL0137 in people with Solid Tumors and Glioblastoma, run by Incuron at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.