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Glioblastoma MultiformePhase 2AxiGIINCT01562197

A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma

A Phase 2 study testing axitinib and Axitinib plus Lomustine in people with Glioblastoma Multiforme, run by Bart Neyns at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial will recruit patients diagnosed with glioblastoma at the time of recurrence or progression following prior treatment with surgery, radiation therapy and alkylating chemotherapy. Patients will be screened and if found eligible will be randomized to one of two treatment arms (1:1 randomization). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
axitinib and Axitinib plus Lomustine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBelgium
Study dates
Apr 2014to Dec 2018
Phase
Phase 2
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Histopathological diagnosis of glioblastoma (= WHO grade IV glioma of the central nervous system); both "de novo" and "secondary" glioblastoma are eligible;
  2. Diagnosis of glioma recurrence or progression following prior treatment with surgery, radiation therapy and alkylating chemotherapy (defined as significant [according to the investigators individual assessment] growth or recurrence of the glioblastoma demonstrated on sequential Gd-MRI before the time of recruitment).
  3. The following disease characteristics should be present:
  4. Presence of a measurable tumor lesion that is characterized by gadolinium enhancement on T1-MRI of the brain (with a longest diameter of > 10 mm);
  5. Enhancing characteristics of the glioblastoma as compared to the normal brain on 18F-FET PET (patients with a non-enhancing lesion are not eligible);
  6. No evidence of clinically meaningful spontaneous intra-tumoral hemorrhage on baseline MRI-imaging or in the prior disease history;
  7. No contraindication for evaluation by Gd-MRI or 18F-FET PET of the brain;
  8. Archival glioma tissue must be available for collection and storage in a centralized tumor bank;
  9. An interval of at least 3 months (12 weeks) after the end of prior radiation therapy; and an interval of at least 4 weeks after the last administration of cytotoxic drug treatment (6 weeks in case of administration of a nitrosureum or mitomycin C); and an interval of at least 4 weeks after the last administration of any other kind of anti glioblastoma treatment;
  10. A stable dose of corticosteroids for at least 14 days before the initiation of study treatment with axitinib;
  11. WHO performance status of 0 or 1;
  12. Life expectancy of ≥12 weeks;
  13. Male or female, 18 years of age or older;
  14. Resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAEv3.0 grade 0 or 1 or back to baseline except for alopecia or hypothyroidism;
  15. Adequate organ function as defined by the following criteria:
  • Total serum bilirubin < 1.5 x ULN (patients with Gilbert's disease exempt)
  • AST and ALT < 2.5 x upper limit of normal (ULN);
  • Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/min
  • Absolute neutrophil count (ANC) > 1500/mm³ without growth factor support
  • Platelets > 75 000 cells/mm³
  • Hemoglobin ≥9 g/dL (which may be obtained by transfusion or growth factor support)
  • Urinary protein <1+ by urine dipstick. If dipstick is ≥1+ then a 24-hour urine collection should be done and the patient may enter only if urinary protein is <2 grams per 24 hours
  1. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.;
  2. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception measures during the period of therapy which should be continued for 4 weeks after the last dose of axitinib. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate;
  3. No previous treatment on an axitinib trial;
  4. No previous treatment with a VEGF or VEGFR-targeted drug (including, but not limited to bevacizumab, aflibercept, cediranib, sorafenib, sunitinib, XL184, and pazopanib);
  5. No gastrointestinal abnormalities including:
  6. Inability to take oral medication.
  7. Requirement for intravenous alimentation.
  8. Prior surgical procedures affecting absorption including gastric resection.
  9. Treatment for active peptic ulcer disease in the past 6 months.
  10. Malabsorption syndromes.
  11. Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
  12. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140 mm Hg, and the baseline diastolic blood pressure readings must be ≤90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible;
  13. No concurrent treatment:
  14. In another therapeutic clinical trial;
  15. With a drug having pro-arrhythmic potential;
  16. With enzyme inducing anti-epileptic drugs (EIAED) within 14 days before dosing with axitinib (e.g. carbamazepine, phenobarbital, phenytoin);
  17. No current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).
  18. No current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).
  19. No requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
  20. No active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
  21. No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure or any unstable arrhythmia, cerebrovascular accident or transient ischemic attack, within the 12 months prior to study drug administration. No current or recent (within 1 month) use of a thrombolytic agent or a thrombo-embolic event;
  22. No known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness;
  23. No serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment;
  24. No history of a malignancy (other than glioma) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years;
  25. No major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of treatment. (Also excluded are patient with fine needle aspirations within 7 days of treatment);
  26. No pregnancy or breastfeeding;
  27. No history of hemoptysis > ½ tsp of bright red blood per day within past 1 week;
  28. No other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
  29. No dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol;
  30. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment;
  31. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Brussel

    Brussels, 1090

Other trials in Belgium

About this study

This clinical trial will recruit patients diagnosed with glioblastoma at the time of recurrence or progression following prior treatment with surgery, radiation therapy and alkylating chemotherapy. Patients will be screened and if found eligible will be randomized to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib treatment-arm will be treated with Axitinib until progression (they can be treated after progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or patients refusal to continue study treatment. Patients randomized to the Axitinib plus Lomustine-arm will receive treatment until progression, unacceptable treatment related toxicity, or patients refusal to continue study treatment.

Being tested
axitinib, Axitinib plus Lomustine
Keywords
axitinib, glioblastoma, recurrent
Medical subject headings
Glioblastoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • axitinibDrug

    Also called Inlyta (TM)

    The starting dose of axitinib (AG-013736) is 5 mg BID administered orally with food.

  • Axitinib plus LomustineDrug

    Also called CCNU

    Lomustine 90mg/m²

Study groups in NCT01562197
Study groupRoleWhat they receive
AxitinibExperimentalaxitinib treatment arm
Receives: Drug: axitinib
Axitinib plus LomustineExperimentalAxitinib plus Lomustine
Receives: Drug: Axitinib plus Lomustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine

    To estimate the anti-tumor effect of axitinib as a single therapeutic agent for the treatment of glioblastoma patients at the time of recurrence/progression following prior surgery, radiation and alkylating chemotherapy and in combination with Lomustine

    Measured: 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2012 (estimated)
  2. Study startApr 2014
  3. Primary completionAug 2018
  4. Study completionDec 2018

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01562197
Sponsor's protocol ID
AxiGII
Acronym
AxiGII
Status last verified
Jan 2019
First submitted
21 Mar 2012
Last updated
24 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing axitinib and Axitinib plus Lomustine in people with Glioblastoma Multiforme, run by Bart Neyns at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine (time frame: 6months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01562197.

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 24 Jan 2019; AzTrials last refreshed its copy on 5 Nov 2026.

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