Phase 2
N=10
Tivozanib for Recurrent Glioblastoma
Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT01846871 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Patients Alive and Progression Free After 6 Months — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tivozanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Alive and Progression Free After 6 Months |
1 | — |
| SECONDARY Number of Participants With Treatment Related Serious Adverse Events |
— | — |
| SECONDARY Median Overall Survival |
8.1 | — |
| SECONDARY Median Progression-Free Survival |
2.3 | — |
| SECONDARY Best RANO Criteria Response |
1; 1; 4; 4 | — |
| SECONDARY Steroid Dosage |
4; 3; 4; 4 | — |
| SECONDARY Change in Tumor Volume |
17.37; -2.012; -2.75; -3.53 | 0.70 |
| SECONDARY Median Apparent Diffusion Coefficient (ADC) |
0.0013; -0.00009; -0.00024; -0.00023 | 0.028 sig |
| SECONDARY Median Ktrans |
0.032; -0.01468; -0.024; -0.030 | 0.0019 sig |
| SECONDARY Relative Oxygen Saturation |
0.64; -0.057; -0.0041; -0.097 | 0.033 sig |
Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the study drug tivozanib is still being studied. It also means that the FDA has not yet approved tivozanib for your type of cancer.
Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it requires to grow.
In this research study, we are looking to see what effects, good and bad, tivozanib will have on you and your disease.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed glioblastoma that has progressed based on imaging or surgery
- Measurable disease
- No more than 3 prior chemotherapy regimens
- Must have recovered from toxicity of prior therapy. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiotherapy; at least 3 weeks since last non-nitrosourea containing chemotherapy regimen or molecularly targeted agent; at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen
- Life expectancy of at least 12 weeks
- Able to tolerate MRIs
- Willing to use adequate, highly effective contraception measures while on study and for at least 45 days after the last dose of study drug
Exclusion Criteria
- Pregnant or breastfeeding
- Major surgical procedure or significant traumatic injury within 28 days of starting therapy; or minor surgical procedure within 7 days
- Receiving other study agents
- Prior therapy with an anti-VEGF agent
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib
- Receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes
- Significant cardiovascular disease
- Non-healing wound, bone fracture or skin ulcer
- Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition with increased risk of perforation; abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
- Uncontrolled intercurrent illness
- Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
- Significant bleeding disorders within 6 months prior to administration of first dose of study drug
- Currently active second primary malignancy
- HIV positive and on combination antiretroviral therapy
- Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure
Data sourced from ClinicalTrials.gov (NCT01846871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.