NCT02014844Phase 2Completed

Phase 2 Study to Investigate the Efficacy and Safety of Aldoxorubicin in Subjects With Glioblastoma

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2016-12Actual

Enrollment · participants28Actual

Source updated2024-05-29Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Glioblastoma

Treatments or interventions studied

250 mg/m2 aldoxorubicinDrugAlso known as INNO-206
350 mg/m2 aldoxorubicinDrugAlso known as INNO-206

Primary outcomes · main study measures

Read the study measures

measure: Objective Response Rate (Complete Response and Partial Response); description: ORR was defined as the proportion of patients with objective CR or PR by RANO working group criteria. CR: required all the following: complete disappearance of all enhancing measurable/ non-measurable disease sustained for at least 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; patients must be off corticosteroids (or on physiologic replacement doses only); and stable or improved clinically. Patients with non-measurable disease only cannot have a CR. PR: Requires all of the following: ≥50% decrease compared with baseline sustained for at least 4 weeks; no PD of non-measurable disease; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan; and stable or improved clinically. Patients with non-measurable disease only can't have a PR.; timeFrame: up to 6 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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