Trial Outcomes & Findings for Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer (NCT NCT00307736)
NCT ID: NCT00307736
Last Updated: 2017-05-10
Results Overview
MTD of Erlotinib was determined using a traditional 3 + 3 dose escalation scheme of three dose levels (50,100,150mg). Successive cohorts of 3-6 patients were enrolled into dose escalation cohorts for 14 day cycles. MTD reflects the highest dose of Erlotinib that had ≤1 out of 6 patients with Dose-Limiting Toxicity (DLT) at the highest dose level below the maximally administered dose. The maximally administered dose is the first dose that causes DLT in \>33% of patients. DLT was defined as: Any grade 4 neutropenia, Any grade 3 thrombocytopenia, or Any ≥ grade 3 non-hematologic toxicity that results in greater than 7 days interruption in therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
3 years
Results posted on
2017-05-10
Participant Flow
This is a single center (institutions comprising Dana Farber Partners/Harvard Cancer Center) trial. Subjects were selected upon referral to the respective clinics of the investigators' institution. Patients Patients were enrolled on to the study between May 2006 and December 2009.
Participant milestones
| Measure |
Phase 1 (Erlotinib 50mg)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Phase 1 (100mg Erlotinib)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Phase 1 (150mg Erlotinib)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Phase II (100mg Erlotinib)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
23
|
|
Overall Study
COMPLETED
|
3
|
3
|
0
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Phase 1 (Erlotinib 50mg)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Phase 1 (100mg Erlotinib)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Phase 1 (150mg Erlotinib)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Phase II (100mg Erlotinib)
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer
Baseline characteristics by cohort
| Measure |
5-fluorocuracil, Bevacizumab, Erlotinib and Radiation
n=32 Participants
All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
|
Stage Grouping
II
|
11 Participants
n=5 Participants
|
|
Stage Grouping
III
|
21 Participants
n=5 Participants
|
|
Clinical staging
T3N0
|
6 Participants
n=5 Participants
|
|
Clinical staging
T3N1
|
15 Participants
n=5 Participants
|
|
Clinical staging
T3N2M0
|
4 Participants
n=5 Participants
|
|
Clinical staging
T3Nx
|
4 Participants
n=5 Participants
|
|
Clinical staging
T4N0
|
2 Participants
n=5 Participants
|
|
Clinical staging
T4N1
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsMTD of Erlotinib was determined using a traditional 3 + 3 dose escalation scheme of three dose levels (50,100,150mg). Successive cohorts of 3-6 patients were enrolled into dose escalation cohorts for 14 day cycles. MTD reflects the highest dose of Erlotinib that had ≤1 out of 6 patients with Dose-Limiting Toxicity (DLT) at the highest dose level below the maximally administered dose. The maximally administered dose is the first dose that causes DLT in \>33% of patients. DLT was defined as: Any grade 4 neutropenia, Any grade 3 thrombocytopenia, or Any ≥ grade 3 non-hematologic toxicity that results in greater than 7 days interruption in therapy.
Outcome measures
| Measure |
5-FU, Bevacizumab, Erlotinib and Radiation
n=9 Participants
All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
|
Grade 4
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Treated at MTD
Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.
All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy
|
100 mg
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Toxicity was grouped together for all phase I dose cohorts and the phase II cohort in order to summarize all the grade 3 or greater toxicities associated with the combined study therapy, instead of focusing on the dose limiting toxicities from the phase 1 dose escalation of Erlotinib. Grade 3 or higher AE data is not available by dose cohort.
Summary of grade 3 or greater toxicity by grade and type. All adverse events were evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.
Outcome measures
| Measure |
5-FU, Bevacizumab, Erlotinib and Radiation
n=32 Participants
All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
|
Grade 4
n=32 Participants
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Treated at MTD
Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.
All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib.
|
|---|---|---|---|
|
Summary of Grade 3 or Greater Toxicity
Rash: acne/acneiform
|
2 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Lymphopenia
|
16 participants
|
5 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Diarrhea w/o prior colostomy
|
6 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Hypophosphatemia
|
3 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
ALT-SGPT
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
AST-SGOT
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Cardiac-ischemia
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Colitis
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Dehydration
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Fatigue
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Febrile neutropenia
|
0 participants
|
1 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Hypertension
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Hypokalemia
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Hyponatremia
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Muco/stomatitis (symptom) oral cavity
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Muco/stomatitis by exam-oral cavity
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Proteinuria
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Radiation dermatitis
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Rash/desquamation
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Rectum-pain
|
1 participants
|
0 participants
|
—
|
|
Summary of Grade 3 or Greater Toxicity
Hyperuricemia
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 3 yearsSummary of disease free survival at 1, 2, and 3 years. Disease free survival is the length of time after primary treatment for cancer ends that the participant survives without any clinical signs or symptoms of that cancer. The data is shown of the percentage of participants still in disease free survival at one, two, and three years.
Outcome measures
| Measure |
5-FU, Bevacizumab, Erlotinib and Radiation
n=32 Participants
All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
|
Grade 4
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Treated at MTD
Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.
All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib.
|
|---|---|---|---|
|
Percentage of Participants With Disease-free Survival
1 Year
|
93.4 percentage of participants
Interval 76.2 to 98.3
|
—
|
—
|
|
Percentage of Participants With Disease-free Survival
2 Years
|
83.4 percentage of participants
Interval 64.7 to 92.7
|
—
|
—
|
|
Percentage of Participants With Disease-free Survival
3 Years
|
75.5 percentage of participants
Interval 55.1 to 87.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Total study population excluding one patient who refused surgery.
Surgical morbidity following R0 resection with one of the following procedures: abdominal perineal resection, low anterior resection, and low anterior resection with coloanal anastomosis.
Outcome measures
| Measure |
5-FU, Bevacizumab, Erlotinib and Radiation
n=31 Participants
All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
|
Grade 4
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Treated at MTD
Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.
All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib.
|
|---|---|---|---|
|
Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
anastomotic leaks
|
4 participants
|
—
|
—
|
|
Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
intra-abdominal infection
|
2 participants
|
—
|
—
|
|
Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
wound infections
|
2 participants
|
—
|
—
|
|
Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
pulmonary embolus
|
1 participants
|
—
|
—
|
|
Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
small bowel obstruction
|
1 participants
|
—
|
—
|
|
Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
urinary obstruction/retention
|
5 participants
|
—
|
—
|
|
Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
fever
|
1 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsPopulation: Patients who completed study therapy.
The number of subjects who achieved a pathologic complete response as determine by pathologist, following completion of the study therapy. Pathologic complete response represents the absence of residual invasive disease in the rectum and in the regional lymph nodes.
Outcome measures
| Measure |
5-FU, Bevacizumab, Erlotinib and Radiation
n=27 Participants
All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
|
Grade 4
n=31 Participants
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
Treated at MTD
n=26 Participants
Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.
All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib.
|
|---|---|---|---|
|
Pathologic Complete Response
|
9 Participants
|
10 Participants
|
7 Participants
|
Adverse Events
5-fluorocuracil, Bevacizumab, Erlotinib and Radiation
Serious events: 8 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5-fluorocuracil, Bevacizumab, Erlotinib and Radiation
n=32 participants at risk
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.6%
5/32 • Number of events 5 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.1%
1/32 • Number of events 1 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Infections and infestations
Febrile Neutropenia
|
3.1%
1/32 • Number of events 1 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Cardiac disorders
Cardiac Ischemia
|
3.1%
1/32 • Number of events 1 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
Other adverse events
| Measure |
5-fluorocuracil, Bevacizumab, Erlotinib and Radiation
n=32 participants at risk
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12
|
|---|---|
|
Gastrointestinal disorders
Abdomen pain
|
37.5%
12/32 • Number of events 19 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
12.5%
4/32 • Number of events 6 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Immune system disorders
Allergic reaction
|
9.4%
3/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Immune system disorders
Allergic rhinitis
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
ALT- SGPT
|
25.0%
8/32 • Number of events 10 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
16/32 • Number of events 28 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Anus- pain
|
9.4%
3/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Psychiatric disorders
Anxiety
|
9.4%
3/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
AST- SGOT
|
31.2%
10/32 • Number of events 13 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Musculoskeletal and connective tissue disorders
Back- pain
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Bilirubin
|
15.6%
5/32 • Number of events 9 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Nervous system disorders
Confusion
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Constipation
|
21.9%
7/32 • Number of events 11 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Creatinine
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Renal and urinary disorders
Cystitis
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Dehydration
|
21.9%
7/32 • Number of events 9 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Psychiatric disorders
Depression
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
90.6%
29/32 • Number of events 65 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • Number of events 8 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
3/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.4%
3/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.4%
3/32 • Number of events 6 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Dysphagia
|
9.4%
3/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb- pain
|
9.4%
3/32 • Number of events 5 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
General disorders
Fatigue
|
90.6%
29/32 • Number of events 67 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
General disorders
Fever w/o neutropenia
|
9.4%
3/32 • Number of events 6 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
4/32 • Number of events 8 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
GI-other
|
18.8%
6/32 • Number of events 10 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
12.5%
4/32 • Number of events 5 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Nervous system disorders
Head/headache
|
18.8%
6/32 • Number of events 7 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
37.5%
12/32 • Number of events 22 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Blood and lymphatic system disorders
Hemorrhage-other
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Hemorrhoids
|
21.9%
7/32 • Number of events 10 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
53.1%
17/32 • Number of events 28 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.4%
3/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Cardiac disorders
Hypertension
|
9.4%
3/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
21.9%
7/32 • Number of events 10 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.9%
7/32 • Number of events 8 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
4/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
4/32 • Number of events 5 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
4/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.6%
13/32 • Number of events 16 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.6%
5/32 • Number of events 5 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
General disorders
Insomnia
|
25.0%
8/32 • Number of events 15 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Blood and lymphatic system disorders
Leukocytes
|
46.9%
15/32 • Number of events 26 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
90.6%
29/32 • Number of events 73 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Nervous system disorders
Memory impairment
|
6.2%
2/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (symptom) oral cavity
|
34.4%
11/32 • Number of events 23 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Mucositis/stomatitis by exam- oral cavity
|
25.0%
8/32 • Number of events 13 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Musculoskeletal and connective tissue disorders
Muscle- pain
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
24/32 • Number of events 41 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Nervous system disorders
Neuropathy-sensory
|
9.4%
3/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Blood and lymphatic system disorders
Neutrophils
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Respiratory, thoracic and mediastinal disorders
Nose- hemorrhage
|
28.1%
9/32 • Number of events 14 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Oral cavity- pain
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Oral gums- pain
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
General disorders
Pain-other
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Reproductive system and breast disorders
Pelvic- pain
|
9.4%
3/32 • Number of events 5 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Blood and lymphatic system disorders
Platelets
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Reproductive system and breast disorders
Proctitis
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Metabolism and nutrition disorders
Proteinuria
|
18.8%
6/32 • Number of events 9 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.6%
5/32 • Number of events 7 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
31.2%
10/32 • Number of events 15 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.6%
5/32 • Number of events 15 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
71.9%
23/32 • Number of events 59 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Rectum- hemorrhage
|
40.6%
13/32 • Number of events 21 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Rectum- pain
|
75.0%
24/32 • Number of events 38 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Renal and urinary disorders
Renal/GU-other
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
General disorders
Rigors/chills
|
21.9%
7/32 • Number of events 8 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
25.0%
8/32 • Number of events 12 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
General disorders
Sweating
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Taste disturbance
|
12.5%
4/32 • Number of events 5 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx- pain
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
18.8%
6/32 • Number of events 12 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
2/32 • Number of events 3 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Reproductive system and breast disorders
Vagina- pain
|
6.2%
2/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Eye disorders
Vision-blurred
|
6.2%
2/32 • Number of events 2 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
4/32 • Number of events 4 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
|
General disorders
Weight loss
|
43.8%
14/32 • Number of events 22 • 3 years
Patients were evaluated for adverse events at each study visit for the duration of their participation in the study. Safety evaluations consisted of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements. Patients discontinued from the treatment phase of the study for any reason would be evaluated \~30 days. Adverse event data was aggregated for phase 1 and 2 portion of the study. Adverse event data by dose cohort is not available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place