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LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538471
Recruitment Status : Terminated (The study was terminated due to lack of patient accrual.)
First Posted : September 2, 2015
Results First Posted : December 9, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Radiation: Radiation therapy
Drug: Study Drug
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description

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) .

Period Title: Overall Study
Started 3
Completed 1
Not Completed 2
Reason Not Completed
Progression of disease             2
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description

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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  66.7%
>=65 years
1
  33.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
61
(60 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
  66.7%
Unknown or Not Reported
1
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
  33.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description 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.
Time Frame until end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
2.Primary Outcome
Title Number of Participants Non-irradiated Tumor Lesions That Had a Response.
Hide Description To determine if treatment with TGFΒ receptor I kinase inhibitor LY2157299 and localized RT achieves an abscopal tumor regression
Time Frame Until next progression up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient completed protocol therapy. 2 patients were removed from the study for disease progression.
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
3.Secondary Outcome
Title Number of Participants Who Received Radiation to the Tumor Who Had a Response.
Hide Description to estimate the local response rate of combining TGFΒ receptor I kinase inhibitor LY2157299 and local radiotherapy
Time Frame 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient continued past 25 weeks.
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
4.Secondary Outcome
Title Number of Participants Who Had a Change in Their T Regulatory Cell Numbers and Function Over the Course of the Study.
Hide Description 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
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Enhanced Tumor Specific Immunity.
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events will be collected throughout the course of the study up to 3 years.
Adverse Event Reporting Description Adverse events are collected at every study visit.
 
Arm/Group Title Arm 1 - Study Drug & Radiation Therapy
Hide Arm/Group Description

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) .

All-Cause Mortality
Arm 1 - Study Drug & Radiation Therapy
Affected / at Risk (%)
Total   2/3 (66.67%)    
Hide Serious Adverse Events
Arm 1 - Study Drug & Radiation Therapy
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Blood and lymphatic system disorders   
Anemia - Grade 3 * 1  1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders   
Intertrochanteric Fracture and Parietal mass and edema * 1  1/3 (33.33%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 - Study Drug & Radiation Therapy
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Gastrointestinal disorders   
Diarrhea - Grade 1 * 1  1/3 (33.33%)  1
Bloating - Grade 1 * 1  1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal Pain - Grade 1 * 1  1/3 (33.33%)  1
Right Hip Pain - Grade 2 * 1  1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders   
Shortness of breath - Grade 1 * 1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
Abdominal Rash - Grade 1 * 1  1/3 (33.33%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Silvia Formenti
Organization: Weill Cornell Medicine
Phone: 212-746-3608
EMail: formenti@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02538471    
Other Study ID Numbers: 1505016222
First Submitted: August 27, 2015
First Posted: September 2, 2015
Results First Submitted: November 20, 2019
Results First Posted: December 9, 2019
Last Update Posted: December 9, 2019