Trial Outcomes & Findings for BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases (NCT NCT02283749)

NCT ID: NCT02283749

Last Updated: 2021-02-02

Results Overview

Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Approximately every 2 months for up to a year

Results posted on

2021-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Xofigo Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xofigo n=5 Participants Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	58 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 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	0 Participants n=99 Participants
Race (NIH/OMB) White	4 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: Approximately every 2 months for up to a year

Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases

Outcome measures

Outcome measures
Measure	Xofigo n=5 Participants Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope
Number of Symptomatic Skeletal Events (SSE) in Patients Receiving Xofigo With NSCLC and Bone Metastases	1 Number of participants experiencing SSE

SECONDARY outcome

Timeframe: During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment

Population: Post 1 year of follow up the number of patients that remain stable or responding

To measure progression-free survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo. Post 1 year of follow up the number of patients that remain stable or responding

Outcome measures

Outcome measures
Measure	Xofigo n=5 Participants Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope
Progression-free Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo	2 Participants

SECONDARY outcome

Timeframe: During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment

To measure overall survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo

Outcome measures

Outcome measures
Measure	Xofigo n=5 Participants Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope
Overall Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo	5 Participants

Adverse Events

Xofigo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Xofigo n=5 participants at risk Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope
Investigations Albumin (hypo)	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations ANC	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Anorexia	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Bilateral Leg Cramps	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Dehydration	40.0% 2/5 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Diarrhea	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Dizziness	40.0% 2/5 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Eye disorder other ( kaleidoscope vision)	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Fatigue	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations flatulence	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations HGB	60.0% 3/5 • Number of events 3 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations HTN	60.0% 3/5 • Number of events 3 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Insomnia	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Lymph	60.0% 3/5 • Number of events 3 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Menorrhagia	100.0% 1/1 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations NA (hypo)	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations nausea	60.0% 3/5 • Number of events 3 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Oral Hemorrhage	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Pain (back, R hip, Ribs )	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations PLT	40.0% 2/5 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations WBC	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations weight gain	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
Investigations Dyspnea	20.0% 1/5 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported. Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.

Additional Information

Kayla Rosati

Brown University Oncology Research Group (BrUOG)

Phone: 14018633000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place