Trial Outcomes & Findings for A Study to testABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System (NCT NCT03670030)

Last Updated: 2021-06-10

Results Overview

Disease control rate at 6 months is the proportion of patients who have partial or complete response or stable disease at 6 months. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

6 months

Results posted on

2021-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	ABI-009 In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle. ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to testABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABI-009 n=5 Participants In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle. ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Age, Continuous	64 years n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	ABI-009 n=5 Participants In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle. ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Disease Control Rate at 6 Months Per RECIST v1.1.	5 Participants

SECONDARY outcome

Timeframe: Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months

Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events

Outcome measures

Outcome measures
Measure	ABI-009 n=5 Participants In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle. ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Percent of Subjects Experiencing Adverse Events	5 Participants

Adverse Events

ABI-009

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABI-009 n=5 participants at risk In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle. ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Nervous system disorders Dementia	20.0% 1/5 • Number of events 1 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Infections and infestations Fever	20.0% 1/5 • Number of events 1 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Number of events 1 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Dehydration	20.0% 1/5 • Number of events 1 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events

Other adverse events

Other adverse events
Measure	ABI-009 n=5 participants at risk In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle. ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Blood and lymphatic system disorders Anemia	60.0% 3/5 • Number of events 21 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Nervous system disorders Confusion	20.0% 1/5 • Number of events 1 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Dehydration	20.0% 1/5 • Number of events 1 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Nervous system disorders Encephalopathy	20.0% 1/5 • Number of events 1 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
General disorders Fatigue	60.0% 3/5 • Number of events 9 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Hypercalcemia	60.0% 3/5 • Number of events 6 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Hyperglycemia	40.0% 2/5 • Number of events 12 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Hyperkalemia	20.0% 1/5 • Number of events 3 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Cardiac disorders Hypertension	20.0% 1/5 • Number of events 6 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 2/5 • Number of events 5 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Hypokalemia	60.0% 3/5 • Number of events 9 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Metabolism and nutrition disorders Hypophosphatemia	20.0% 1/5 • Number of events 3 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Blood and lymphatic system disorders Platelet count decrease	60.0% 3/5 • Number of events 25 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Skin and subcutaneous tissue disorders Rash	60.0% 3/5 • Number of events 13 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Renal and urinary disorders Urinary tract infection	20.0% 1/5 • Number of events 3 • Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events

Additional Information

Robert Ramirez, DO

Ochsner Medical Center

Phone: 504-464-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place