Trial Outcomes & Findings for LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer (NCT NCT02538471)

Last Updated: 2019-12-09

Results Overview

Patients who have received at least one 14 days cycle of the study drug will be followed for toxicity (lack of grade 4 toxicity- primary safety end point). Physical exam (including labs) will be performed every 2 weeks while on the study. Patients will be followed with follow-up visits monthly for the first three months after completing therapy then annually for 5 years. Adverse Events will be monitored throughout the course of the study using the NCI CTCAE vers. 4.0.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

until end of study

Results posted on

2019-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 - Study Drug & Radiation Therapy Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 - Study Drug & Radiation Therapy Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Overall Study Progression of disease	2

Baseline Characteristics

LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 - Study Drug & Radiation Therapy n=3 Participants Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: until end of study

Outcome measures

Outcome measures
Measure	Arm 1 - Study Drug & Radiation Therapy n=3 Participants Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Number of Participants With Adverse Events	3 Participants

PRIMARY outcome

Timeframe: Until next progression up to 3 years

Population: Only 1 patient completed protocol therapy. 2 patients were removed from the study for disease progression.

To determine if treatment with TGFΒ receptor I kinase inhibitor LY2157299 and localized RT achieves an abscopal tumor regression

Outcome measures

Outcome measures
Measure	Arm 1 - Study Drug & Radiation Therapy n=1 Participants Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Number of Participants Non-irradiated Tumor Lesions That Had a Response.	1 Participants

SECONDARY outcome

Timeframe: 25 weeks

Population: Only one patient continued past 25 weeks.

to estimate the local response rate of combining TGFΒ receptor I kinase inhibitor LY2157299 and local radiotherapy

Outcome measures

Outcome measures
Measure	Arm 1 - Study Drug & Radiation Therapy n=1 Participants Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Number of Participants Who Received Radiation to the Tumor Who Had a Response.	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Due to early termination of the study, blood samples at all time points could not be collected. So this outcome measure couldn't be analyzed.

To determine if treatment with TGFβ receptor I kinase inhibitor LY2157299 and localized RT alters the numbers and function of T-reg cells in patients with metastatic breast cancer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Due to early termination of the study, blood samples at all time points could not be collected. So this outcome measure couldn't be analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1 - Study Drug & Radiation Therapy

Serious events: 2 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 - Study Drug & Radiation Therapy n=3 participants at risk Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Musculoskeletal and connective tissue disorders Intertrochanteric Fracture and Parietal mass and edema	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.
Blood and lymphatic system disorders Anemia - Grade 3	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.

Other adverse events

Other adverse events
Measure	Arm 1 - Study Drug & Radiation Therapy n=3 participants at risk Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet. The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring. Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment. Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week. Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
Gastrointestinal disorders Diarrhea - Grade 1	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.
Skin and subcutaneous tissue disorders Abdominal Rash - Grade 1	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.
Gastrointestinal disorders Bloating - Grade 1	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain - Grade 1	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.
Respiratory, thoracic and mediastinal disorders Shortness of breath - Grade 1	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.
Musculoskeletal and connective tissue disorders Right Hip Pain - Grade 2	33.3% 1/3 • Number of events 1 • Adverse events will be collected throughout the course of the study up to 3 years. Adverse events are collected at every study visit.

Additional Information

Dr. Silvia Formenti

Weill Cornell Medicine

Phone: 212-746-3608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place