Glioblastoma Multiforme (Grade IV) of CerebellumPhase 1NCT02270034
Study to Evaluate Safety and Activity of Crizotinib With Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma
A Phase 1 study testing Crizotinib in people with Glioblastoma Multiforme (Grade IV) of Cerebellum, run by Grupo Español de Investigación en Neurooncología at 4 sites in Spain.
Trial summary
This multicenter, open-label, phase Ib trial aims to assess the safety and activity and safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme (Grade IV) of Cerebellum
- What is being tested?
- Crizotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesSpain
- Study dates
- 13 Aug 2014to 26 Oct 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document.
- Male or Female ≥18 years old and ≤ 70 years old
- Newly diagnosed glioblastoma (GB) confirmed by biopsy or resection 4-7 weeks before registration.
- Patients must have at least 15 unstained slides or 1 tissue block (frozen or paraffin embedded) available from a prior biopsy or surgery (archival tumor material).
- Patients must have sufficient time for recovery from prior surgery (at least 4 weeks).
- Karnofsky Performance Score (KPS) ≥ 60%.
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- Adequate hematologic function: Hemoglobin ≥ 10 g/dL, Leukocytes > 3,000/mcL, absolute neutrophil count (UNL) ≥ 1,500 cells/ul, platelets ≥ 100,000 cells/ul.
- Adequate liver function: Bilirubin ≤ 2 X upper limit of normal (ULN); aspartate aminotrasferase (AST) (SGOT) ≤ 2.5 X ULN
- Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2l for subjects with creatinine levels above institutional normal.
- The effects of crizotinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or harrier method of birth control; abstinence; surgical sterilization) prior to study entry and for the duration of study participation and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 2 weeks prior to starting treatment.
Who cannot join
- Presence of extra-cranial metastatic disease.
- Any prior radiotherapy (RT) or chemotheraphy (QT) treatment.
- Patients must not have received prior Gliadel wafers.
- The use of enzyme-inducing antiepileptic drugs will not be allowed. Those patients taking enzyme-inducing antiepileptic drugs required a 7-day washout period before registration.
- Any surgery (not including minor diagnostic procedures such as lymph node biopsy) within 2 weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures.
- Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form.
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- Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.
- Uncontrolled or significant cardiovascular disease, including:
- A myocardial infarction within 12 months;
- Uncontrolled angina within 6 months;
- Congestive heart failure within 6 months;
- Diagnosed or suspected congenital long QT syndrome;
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
- Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (>470 msec);
- Any history of second or third degree heart block (may be eligible if currently have a pacemaker);
- Heart rate <50/minute on pre-entry electrocardiogram;
- Uncontrolled hypertension.
- Any patient with a history of significant cardiovascular disease, even if currently controlled, or who has signs or symptoms suggesting impaired left ventricular function in the judgment of the investigator must have a screening left ventricular ejection fraction (LVEF) evaluation by ECHO or angyography (MUGA). Patients with LVEF measurements below local institutional lower limit of normal or less than 50% will not be eligible.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. Patients will not be eligible if they have evidence of other malignancy requiring therapy other than surgery within the last 3 years.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Del Mar
Barcelona, 08003
Hospital Clínic de Barcelona
Barcelona, 08036
Institut Català D'Oncologia L'Hospitalet (Ico)
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: Phase Ib, Open-label, Multicenter, Dose-escalation Study Followed by an Extension Phase to Evaluate the Safety and Activity of the Combination of Crizotinib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma
This multicenter, open-label, phase Ib trial aims to assess the safety and activity and safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients with newly diagnosed glioblastoma.
- Being tested
- Crizotinib
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizotinibDrug
Crizotinib is added to Stupp method
| Study group | Role | What they receive |
|---|---|---|
| Cohort crizotinib | Experimental | Combination of crizotinib with temozolomide and radiotherapy following Stupp regime Receives: Drug: Crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment safety
Number of participants with adverse events as a measure of safety and tolerability
Measured: 7 months
Secondary outcomes (3)
Recommended dose in phase II
Based on pharmakinetic analysis by Cmax
Measured: 7 months
Anti-tumor activity
Measured: 7 months
Overall Survival
Time between start of treatment and death
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start13 Aug 2014
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme (Grade IV) of CerebellumStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Investigación en Neurooncología
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Juan Manuel Sepúlveda, MD, Study chair, Hospital 12 de OctubreMaría Martínez, MD, Study chair, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270034
- Sponsor's protocol ID
- GEINO 1402
- Status last verified
- Feb 2022
- First submitted
- 14 Oct 2014
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib, Open-label, Multicenter, Dose-escalation Study Followed by an Extension Phase to Evaluate the Safety and Activity of the Combination of Crizotinib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT02270034
- Acronym / sponsor ID
- GEINO 1402
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Grupo Español de Investigación en NeurooncologíaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 13 Aug 2014 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 21 Oct 2014 (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 multicenter, open-label, phase Ib trial aims to assess the safety and activity and safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients with newly diagnosed glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort crizotinib | Experimental | Drug: CrizotinibCombination of crizotinib with temozolomide and radiotherapy following Stupp regime |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Male or Female ≥18 years old and ≤ 70 years old
- Newly diagnosed glioblastoma (GB) confirmed by biopsy or resection 4-7 weeks before registration.
- Patients must have at least 15 unstained slides or 1 tissue block (frozen or paraffin embedded) available from a prior biopsy or surgery (archival tumor material).
- Patients must have sufficient time for recovery from prior surgery (at least 4 weeks).
Key exclusion criteria (19 listed)
- Presence of extra-cranial metastatic disease.
- Any prior radiotherapy (RT) or chemotheraphy (QT) treatment.
- Patients must not have received prior Gliadel wafers.
- The use of enzyme-inducing antiepileptic drugs will not be allowed. Those patients taking enzyme-inducing antiepileptic drugs required a 7-day washout period before registration.
- Any surgery (not including minor diagnostic procedures such as lymph node biopsy) within 2 weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures.
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 |
|---|---|---|
| CrizotinibCrizotinib is added to Stupp method | Drug | Cohort crizotinib |
Primary outcome
Treatment safety
Time frame: 7 months
Number of participants with adverse events as a measure of safety and tolerability
3 secondary outcomes
Recommended dose in phase II
Time frame: 7 months
Anti-tumor activity
Time frame: 7 months
Overall Survival
Time frame: Two years
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 Mar 2022.
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.
Juan Manuel Sepúlveda, MD study chair
Hospital 12 de Octubre
María Martínez, MD study chair
Hospital del Mar
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 Crizotinib in people with Glioblastoma Multiforme (Grade IV) of Cerebellum, run by Grupo Español de Investigación en Neurooncología at 4 sites in Spain.
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 10 inclusion and 19 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 Mar 2022. 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 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 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?
Treatment safety (time frame: 7 months). 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 Mar 2022.