A Phase 2 interventional study of bevacizumab [Avastin] and temozolomide in Glioblastoma Multiforme, sponsored by Hoffmann-La Roche. Completed at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-08.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 32 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: bevacizumab [Avastin] · Drug: temozolomide
Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks
Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.
Time frame: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS - Time to Event
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.
Time frame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study
Time frame: BL, 24 weeks (after 6th cycle)
Overall Survival - Percentage of Participants With an Event
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.
Time frame: BL, every 28 days, until death or end-of-study, an average of 32 weeks
Overall Survival - Time to Event
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.
Time frame: BL, every 28 days, until death or end-of-study, an average of 32 weeks
Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.
Time frame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
| Milestone | Bevacizumab + Temozolomide |
|---|---|
| Started | 32 |
| Completed | 2 |
| Not completed | 30 |
| Withdrew: Death | 22 |
| Withdrew: Adverse event | 3 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 1 |
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.
| percentage of participants | Bevacizumab + Temozolomide |
|---|---|
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | 96.88 |
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.
| weeks | Bevacizumab + Temozolomide |
|---|---|
| PFS - Time to Event | 18.29 (15.43 to 23.57) |
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.
| percentage of participants | Bevacizumab + Temozolomide |
|---|---|
| Overall Survival - Percentage of Participants With an Event | 75.00 |
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.
| weeks | Bevacizumab + Temozolomide |
|---|---|
| Overall Survival - Time to Event | 31.43 (25.14 to 38.29) |
| survival probability | Bevacizumab + Temozolomide |
|---|---|
| PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study | 0.30000 ± 0.0819 |
Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.
| percentage of participants | Bevacizumab + Temozolomide |
|---|---|
| Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR) | 40.6 |
Collected over Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab + Temozolomide | — | 8/32 (25%) | 32/32 (100%) |
| Event | Bevacizumab + Temozolomide |
|---|---|
| Lung (pneumonia)Infections and infestations | 2/32 |
| FeverGeneral disorders | 2/32 |
| Upper respiratory tract infectionInfections and infestations | 1/32 |
| Neurological disorder NOSNervous system disorders | 1/32 |
| SeizuresNervous system disorders | 1/32 |
| ThrombosisVascular disorders | 1/32 |
| Bladder haemorrhageRenal and urinary disorders | 1/32 |
| Intracranial haemorrhageBlood and lymphatic system disorders | 1/32 |
| Back painMusculoskeletal and connective tissue disorders | 1/32 |
| Event | Bevacizumab + Temozolomide |
|---|---|
| FatigueGeneral disorders | 18/32 |
| Lymphocyte count decreasedBlood and lymphatic system disorders | 16/32 |
| Platelet count decreasedBlood and lymphatic system disorders | 15/32 |
| NauseaGastrointestinal disorders | 11/32 |
| Olfactory nerve disorderNervous system disorders | 9/32 |
| HeadacheNervous system disorders | 9/32 |
| AnorexiaMetabolism and nutrition disorders | 8/32 |
| Upper respiratory infectionInfections and infestations | 8/32 |
| HypertensionVascular disorders | 7/32 |
| Neutrophil count decreasedBlood and lymphatic system disorders | 6/32 |
Intent-to-treat (ITT) population: all enrolled participants.
| Age, Continuous(years) | Bevacizumab + Temozolomide |
|---|---|
| Mean | 56.19 ± 10.58 |
| Sex: Female, Male(Participants) | Bevacizumab + Temozolomide |
|---|---|
| Female | 15 |
| Male | 17 |
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