Trial Outcomes & Findings for Phase 2 Study to Investigate the Efficacy and Safety of Aldoxorubicin in Subjects With Glioblastoma (NCT NCT02014844)

NCT ID: NCT02014844

Last Updated: 2024-05-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

up to 6 months

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	250 mg/m^2 Aldoxorubicin Subjects received 250 mg/m\^2 aldoxorubicin IV.	350 mg/m^2 Aldoxorubicin Subjects received 350 mg/m\^2 aldoxorubicin IV.
Overall Study STARTED	21	7
Overall Study COMPLETED	21	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	250 mg/m^2 Aldoxorubicin n=21 Participants Subjects received 250 mg/m\^2 aldoxorubicin IV.	350 mg/m^2 Aldoxorubicin n=7 Participants Subjects received 350 mg/m\^2 aldoxorubicin IV.	Total n=28 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 10.29 • n=5 Participants	54.2 years STANDARD_DEVIATION 15.37 • n=7 Participants	54.4 years STANDARD_DEVIATION 11.44 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	5 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

Outcome measures

Outcome measures
Measure	250 mg/m^2 Aldoxorubicin n=21 Participants Subjects received 250 mg/m\^2 aldoxorubicin IV. 250 mg/m\^2 aldoxorubicin	350 mg/m^2 Aldoxorubicin n=7 Participants Subjects received 350 mg/m\^2 aldoxorubicin IV. 350 mg/m\^2 aldoxorubicin
Objective Response Rate (Complete Response and Partial Response)	0 Participants	1 Participants

Adverse Events

250 mg/m^2 Aldoxorubicin

Serious events: 6 serious events

Other events: 21 other events

Deaths: 16 deaths

350 mg/m^2 Aldoxorubicin

Serious events: 2 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	250 mg/m^2 Aldoxorubicin n=21 participants at risk Subjects received 250 mg/m\^2 aldoxorubicin IV.	350 mg/m^2 Aldoxorubicin n=7 participants at risk Subjects received 350 mg/m\^2 aldoxorubicin IV.
Blood and lymphatic system disorders Febrile Neutropenia	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
General disorders Mucosal Inflammation	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Infections and infestations Oral Candidiasis	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Infections and infestations Pneumonia	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Infections and infestations Gastroenteritis viral	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Metabolism and nutrition disorders Hyperglycemia	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Gastrointestinal disorders Large intestine perforation	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Nervous system disorders Seizure	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	14.3% 1/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Nervous system disorders Cerebrolvascular accident	4.8% 1/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	0.00% 0/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Nervous system disorders Hemiparesis	0.00% 0/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	14.3% 1/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Nervous system disorders Encephalopathy	0.00% 0/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	14.3% 1/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.
Nervous system disorders Somnolence	0.00% 0/21 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.	14.3% 1/7 • AEs that occurred during the clinical trial, starting at the time of the initial study drug infusion, and the follow-up period were recorded on the appropriate AE page of the CRF. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were reported. The SAE reporting period ended if the subject began an alternative therapy within 30 days of the last administration of study drug. The expected duration is 24 months.

Other adverse events

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place