Trial Outcomes & Findings for A Study of Yttrium-90 Radioactive Resin Microspheres to Treat Colorectal Adenocarcinoma Metastatic to the Liver (NCT NCT01098422)

NCT ID: NCT01098422

Last Updated: 2021-08-24

Results Overview

Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria using Computerized Tomography (CT) assessment of tumor(s)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2021-08-24

Participant Flow

Participant milestones

Measure	Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Yttrium-90 Radioactive Resin Microspheres n=10 Participants Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=10 Participants
Age, Categorical >=65 years	5 Participants n=10 Participants
Age, Continuous	64.3 years n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: 2 years

Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria using Computerized Tomography (CT) assessment of tumor(s)

Outcome measures

Measure	Yttrium-90 Radioactive Resin Microspheres n=9 Participants Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
PFS	7.6 Months Standard Deviation 12.7

SECONDARY outcome

Timeframe: 6 Months

Overall survival assessed at 6 months since diagnosis of progression on first-line therapy

Outcome measures

Measure	Yttrium-90 Radioactive Resin Microspheres n=9 Participants Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
Percentage of Participants Achieving Overall Survival at 6 Months	78 percent

SECONDARY outcome

Timeframe: 2 years

Tumor response rate as determined by RECIST criteria using CT or Magnetic Resonance Imaging (MRI) assessment of tumor size every 3 months

Outcome measures

Measure	Yttrium-90 Radioactive Resin Microspheres n=9 Participants Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
Number of Participants With Responses as Determined by RECIST Criteria Using CT or Magnetic Resonance Imaging (MRI) Assessment	9 participants

SECONDARY outcome

Timeframe: 1 years

Number of adverse events by grade

Outcome measures

Measure	Yttrium-90 Radioactive Resin Microspheres n=9 Participants Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
Adverse Events Nausea	10 Events
Adverse Events Emesis	7 Events
Adverse Events Pain	13 Events
Adverse Events Weight Loss	4 Events
Adverse Events Fatigue	39 Events
Adverse Events Fever	2 Events
Adverse Events Bilirubin	4 Events
Adverse Events Alk Phos	20.5 Events
Adverse Events ALT	1 Events
Adverse Events AST	1 Events

SECONDARY outcome

Timeframe: 60 days

Number of Participants with 60 Day All-cause Mortality

Outcome measures

Measure	Yttrium-90 Radioactive Resin Microspheres n=9 Participants Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
60 Day All-cause Mortality Rate	0 participants

Adverse Events

Yttrium-90 Radioactive Resin Microspheres

Serious events: 9 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Measure	Yttrium-90 Radioactive Resin Microspheres n=9 participants at risk Yttrium-90 Radioactive Resin Microspheres Yttrium-90 Radioactive Resin Microspheres: An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Emesis	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Fatigue	44.4% 4/9 • Number of events 4
Hepatobiliary disorders Alk Phos	22.2% 2/9 • Number of events 2
Hepatobiliary disorders Bilirubin	11.1% 1/9 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tony Reid

UC San Diego

Phone: 8583531942

Email: treid@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place