AstrocytomaPhase 1NCT04047303
CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma
A Phase 1 study testing CC-90010 in people with Astrocytoma and Glioblastoma, run by Celgene at 4 sites in 2 countries.
Trial summary
CC-90010-GBM-001 is a multi-center, open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD) and CNS penetration of CC-90010 following short-term interval therapy (4 daily doses ) prior to surgery, in subjects with progressive or recurrent WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Glioblastoma
- What is being tested?
- CC-90010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 2 Jan 2020to 3 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Men and women ≥ 18 years of age,) with recurrent or progressive WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma or recurrent WHO Grade IV Glioblastoma .
- Subjects must have previously completed standard or a hypofractionated course of radiation therapy and have been exposed to procarbazine, lomustine and vincristine (for Grade II Astrocytoma), including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy, with radiation completed > 12 weeks prior to the first CC-90010 dose (Day 1).
- Subject must be in first or second recurrence.
- Subject must have archival tumor tissue suitable for genetic testing and must give permission to access and test the tissue.
- Subject is considered an appropriate candidate for surgical resection of the recurrent tumor tissue (salvage resection).
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- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Subject must meet laboratory values at screening:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without growth factor support for 7 days (14 days if subject received pegfilgrastim).
- Hemoglobin (Hgb) ≥10 g/dL
- Platelet count (plt) ≥100 x 10^9/L
- Serum potassium concentration within normal range, or correctable with supplements
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x Upper Limit of Normal (ULN).
- Serum total bilirubin ≤ 1.5 x ULN.
- Serum creatinine ≤ 1.5 x ULN or measured glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m2 using an exogenous filtration marker such as iohexol, inulin, 51Cr EDTA or 1 iothalamate, or creatinine clearance of ≥ 50 mL/min using Cockroft-Gault equation.
- Serum albumin > 3.5 g/dL
- PT (or INR) and APTT ≤ normal range
- Females and males must agree to contraceptive methods and avoid conceiving throughout study and up to 46 days (females) and 106 days (males) following last dose of CC-90010.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has received anti-cancer therapy (either approved or investigational) within ≤ 4 weeks (6 weeks for nitrosoureas) or 5 half-lives, whichever is shorter, prior to starting CC-90010. If subject received prior immunotherapy (immune checkpoint inhibitor, vaccine, etc.), a 2 week wash-out is required. For a subject treated with the Optune-TTF device, a 2 day period without use is required.
- Toxicities resulting from prior chemotherapy, surgery, or radiotherapy must have resolved to ≤ NCI CTCAE (version 5.0) Grade 1 prior to starting CC-90010 treatment (with the exception of Grade 3 alopecia).
- Subject has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to starting CC-90010 or subject who has not recovered from surgery.
- Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of CC-90010.
- Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
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- Evidence of CNS hemorrhage on baseline MRI or CT scan (except for post-surgical, asymptomatic Grade 1 hemorrhage that has been stable for at least 4 weeks).
- Subject who requires increasing doses of corticosteroids to treat symptomatic cerebral edema within 7 days of study therapy.
- Known symptomatic acute or chronic pancreatitis.
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- LVEF < 45% as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO).
- Complete left bundle branch or bifascicular block.
- Congenital long QT syndrome.
- Persistent or clinically meaningful ventricular arrhythmias or atrial fibrillation.
- QTcF ≥ 480 msec on Screening ECG (mean of triplicate recordings); a marked baseline prolongation of QT/QTc interval, using Fridericia´s QT correction formula.
- History of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome.
- Use of concomitant medications that prolong the QT/QTc interval.
- Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting CC-90010.
- Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg).
- Pregnant or nursing females.
- Known HIV infection.
- Known chronic active hepatitis B or C virus (HBV, HCV) infection.
- Subject with a requirement for ongoing treatment with therapeutic dosing of anticoagulants or for ongoing prophylactic anticoagulation. Low dose low molecular weight heparin for catheter maintenance is allowed.
- History of concurrent second cancers requiring active, ongoing systemic treatment.
- Evidence of history of bleeding diathesis.
- Subject with known prior episodes of non-arteritic anterior ischemic optic neuropathy (NAION) should be excluded from the study. CC-90010 should be used with caution in subjects with retinitis pigmentosa.
- Subject has any significant medical condition (e.g., active or uncontrolled infection or renal disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating (or compromise compliance) in the study or would place the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject with poor bone marrow reserve as assessed by Investigator such as in the following condition:
- Requiring regular hematopoietic support (blood or platelet transfusions, erythropoietin, granulocyte colony stimulating factor [GCSF] or other hematopoietic growth factors)
- Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to starting study drug.
- Acute symptoms must have resolved and based on investigator assessment in consultation with the medical monitor, there are no sequelae that would place the participant at a higher risk of receiving study treatment.
- Previous SARS-CoV-2 vaccine within 14 days of starting drug study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Local Institution - 102
Boston, Massachusetts, 02215
Local Institution - 101
Tampa, Florida, 33612
Spain2 sites
Local Institution - 302
Madrid, 28040
Local Institution - 301
Madrid, 28041
About this study
Official title: A Phase 1, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of CC-90010 in Preoperative Subjects With Progressive or Recurrent Who Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and Recurrent Glioblastoma Scheduled for Resection
CC-90010-GBM-001 is a multi-center, open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD) and CNS penetration of CC-90010 following short-term interval therapy (4 daily doses ) prior to surgery, in subjects with progressive or recurrent WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and recurrent Glioblastoma who have failed radiation and chemotherapy, and who are candidates for surgical tumor resection as part of their salvage regimen (planned salvage resection).
- Conditions
- Astrocytoma, Glioblastoma
- Being tested
- CC-90010
- Keywords
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Glioblastoma, CC-90010, CNS, 2nd line or relapsed
- Medical subject headings
- Astrocytoma, Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90010Drug
CC-90010
| Study group | Role | What they receive |
|---|---|---|
| Administration of CC-90010 | Experimental | During the preoperative period, all subjects will be given a course of orally administrated CC-90010 at 30 mg once daily for 4 consecutive days on Cycle 1 Day 1 to Day 4. The last CC-90010 dose (Day 4) will be administrated 6-24 hours prior to brain tumor resection. Following recovery from surgery and a minimum of 4 weeks from the first CC-90010 dose (Cycle 1 Day 1), subjects who are fit to continue study treatment my restart CC-90010 on Day 1 of Cycle 2 at 45 mg given orally once daily for 4 consecutive days followed by 24 consecutive days off (4 days on/24 days off), in each 28 day cycle. Receives: Drug: CC-90010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratumoral concentration of CC-90010 in tumor tissue collected intraoperatively
Intratumoral concentration of CC-90010 will be summarized using descriptive statistics
Measured: Up to 4 days following C1D1
Pharmacokinetics - AUC24
Area under the plasma concentration time-curve
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics - AUClast
Area under the plasma concentration time-curve
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics - Cmax
Maximum observed plasma concentration
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics - Tmax
Time to maximum plasma concentration
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics - t1/2
Terminal half-life
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics - CL/F
Apparent clearance
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics - V2/F
Apparent volume of distribution
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse event
Measured: From enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start2 Jan 2020
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047303
- Sponsor's protocol ID
- CC-90010-GBM-001
- Other IDs
- U1111-1235-8082, 2019-000241-12, 2019
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2019
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of CC-90010 in Preoperative Subjects With Progressive or Recurrent Who Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and Recurrent Glioblastoma Scheduled for Resection
- ClinicalTrials.gov ID
- NCT04047303
- Acronym / sponsor ID
- CC-90010-GBM-001
- Conditions
- Astrocytoma, Glioblastoma
- Keywords
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Glioblastoma, CC-90010, CNS, 2nd line or relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 6 Aug 2019 (actual)
- 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.
CC-90010-GBM-001 is a multi-center, open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD) and CNS penetration of CC-90010 following short-term interval therapy (4 daily doses ) prior to surgery, in subjects with progressive or recurrent WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and recurrent Glioblastoma who have failed radiation and chemotherapy, and who are candidates for surgical tumor resection as part of their salvage regimen (planned salvage resection).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CC-90010 | Experimental | Drug: CC-90010During the preoperative period, all subjects will be given a course of orally administrated CC-90010 at 30 mg once daily for 4 consecutive days on Cycle 1 Day 1 to Day 4. The last CC-90010 dose (Day 4) will be administrated 6-24 hours prior to brain tumor resection. Following recovery from surgery and a minimum of 4 weeks from the first CC-90010 dose (Cycle 1 Day 1), subjects who are fit to continue study treatment my restart CC-90010 on Day 1 of Cycle 2 at 45 mg given orally once daily for 4 consecutive days followed by 24 consecutive days off (4 days on/24 days off), in each 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men and women ≥ 18 years of age,) with recurrent or progressive WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma or recurrent WHO Grade IV Glioblastoma .
- Subjects must have previously completed standard or a hypofractionated course of radiation therapy and have been exposed to procarbazine, lomustine and vincristine (for Grade II Astrocytoma), including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy, with radiation completed > 12 weeks prior to the first CC-90010 dose (Day 1).
- Subject must be in first or second recurrence.
- Subject must have archival tumor tissue suitable for genetic testing and must give permission to access and test the tissue.
- Subject is considered an appropriate candidate for surgical resection of the recurrent tumor tissue (salvage resection).
Key exclusion criteria (33 listed)
- Subject has received anti-cancer therapy (either approved or investigational) within ≤ 4 weeks (6 weeks for nitrosoureas) or 5 half-lives, whichever is shorter, prior to starting CC-90010. If subject received prior immunotherapy (immune checkpoint inhibitor, vaccine, etc.), a 2 week wash-out is required. For a subject treated with the Optune-TTF device, a 2 day period without use is required.
- Toxicities resulting from prior chemotherapy, surgery, or radiotherapy must have resolved to ≤ NCI CTCAE (version 5.0) Grade 1 prior to starting CC-90010 treatment (with the exception of Grade 3 alopecia).
- Subject has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to starting CC-90010 or subject who has not recovered from surgery.
- Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of CC-90010.
- Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
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 |
|---|---|---|
| CC-90010CC-90010 | Drug | Administration of CC-90010 |
Primary outcome
Intratumoral concentration of CC-90010 in tumor tissue collected intraoperatively
Time frame: Up to 4 days following C1D1
Intratumoral concentration of CC-90010 will be summarized using descriptive statistics
Pharmacokinetics - AUC24
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Area under the plasma concentration time-curve
Pharmacokinetics - AUClast
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Area under the plasma concentration time-curve
Pharmacokinetics - Cmax
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Maximum observed plasma concentration
Pharmacokinetics - Tmax
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Time to maximum plasma concentration
Pharmacokinetics - t1/2
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Terminal half-life
Pharmacokinetics - CL/F
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Apparent clearance
Pharmacokinetics - V2/F
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Apparent volume of distribution
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
Results and safety
The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-90010 in people with Astrocytoma and Glioblastoma, run by Celgene at 4 sites in 2 countries.
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 18 inclusion and 33 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: stopped early, as of the sponsor's last update on 5 Jul 2024. 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, Spain. 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 was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
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?
Intratumoral concentration of CC-90010 in tumor tissue collected intraoperatively (time frame: Up to 4 days following C1D1). The study lists 8 primary outcomes in all. 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 5 Jul 2024.