Trial Outcomes & Findings for Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas (NCT NCT02037230)
NCT ID: NCT02037230
Last Updated: 2020-02-17
Results Overview
Probability of dose limiting toxicities was calculated for each dose (p\[DLT/d\]) using the Time to Event Continual Reassessment Method (TITE-CRM). The target DLT rate was 0.30. Dose level 1 (150 mg AZD1775) was determined to be the MTD and recommended phase 2 dose (RP2D).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
The observation period for MTD is defined as the first 4 cycles of treatment (with a 3 week break between cycle 3 and cycle 4), for a total of 105 days in length.
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
AZD-1775 100 mg
AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 125 mg
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
13
|
9
|
11
|
|
Overall Study
Completed 4 Cycles of Treatment
|
1
|
9
|
7
|
9
|
|
Overall Study
COMPLETED
|
0
|
7
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
AZD-1775 100 mg
n=1 Participants
AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 125 mg
n=13 Participants
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
n=9 Participants
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
n=11 Participants
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
66 years
n=7 Participants
|
62 years
n=5 Participants
|
60 years
n=4 Participants
|
68 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The observation period for MTD is defined as the first 4 cycles of treatment (with a 3 week break between cycle 3 and cycle 4), for a total of 105 days in length.Population: All participants who received at least one dose of the study drug were evaluable for MTD.
Probability of dose limiting toxicities was calculated for each dose (p\[DLT/d\]) using the Time to Event Continual Reassessment Method (TITE-CRM). The target DLT rate was 0.30. Dose level 1 (150 mg AZD1775) was determined to be the MTD and recommended phase 2 dose (RP2D).
Outcome measures
| Measure |
AZD1775 (MK-1775), Gemcitabine, Radiation Therapy
n=34 Participants
AZD1775 (MK-1775) will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy.
|
AZD-1775 125 mg
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy.
|
150 mg
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First cycle of treatmentPopulation: 20 participants were evaluable for this outcome measure. Two sequential skin punch biopsies were obtained from 20 of the 34 study participants.
During the first cycle of treatment, patients underwent 2 biopsies: 3 h after treatment with gemcitabine (but before MK- 1775), and 2 hours after MK-1775. WEE1 signaling was assessed using immunohistochemistry (IHC) to measure phosphorylation of various markers including Cdk1 (Y15). Inhibition was quantified as the within subject change in the above markers between the two biopsy timepoints. Descriptive statistics of inhibition across subjects (for each marker) were calculated and reported by dose level.
Outcome measures
| Measure |
AZD1775 (MK-1775), Gemcitabine, Radiation Therapy
n=1 Participants
AZD1775 (MK-1775) will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy.
|
AZD-1775 125 mg
n=8 Participants
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
n=5 Participants
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
n=6 Participants
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
|---|---|---|---|---|
|
Number of Patients With Phosphorylation Inhibition of Greater Than 0
|
1 participants
|
7 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 48 months following treatmentOverall survival (OS) summarized by Kaplan-Meier curves and characterized by descriptive statistics such as median OS. The time frame for data collection for OS varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
Outcome measures
| Measure |
AZD1775 (MK-1775), Gemcitabine, Radiation Therapy
n=1 Participants
AZD1775 (MK-1775) will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy.
|
AZD-1775 125 mg
n=13 Participants
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
n=9 Participants
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
n=11 Participants
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
|---|---|---|---|---|
|
Overall Survival
|
21.96 months
|
21.73 months
Interval 16.67 to 39.81
|
23.84 months
Interval 8.28 to 34.88
|
22.45 months
Interval 6.81 to 25.35
|
SECONDARY outcome
Timeframe: Up to 48 months following treatmentTime from date of registration to date of documented disease progression summarized by Kaplan-Meier method. The time frame for data collection varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
Outcome measures
| Measure |
AZD1775 (MK-1775), Gemcitabine, Radiation Therapy
n=1 Participants
AZD1775 (MK-1775) will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy.
|
AZD-1775 125 mg
n=13 Participants
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
n=9 Participants
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
n=11 Participants
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
|---|---|---|---|---|
|
Time From Date of Registration to Date of Documented Disease Progression
|
8.05 months
|
9.44 months
Interval 7.96 to 9.93
|
9.90 months
Interval 4.9 to 18.02
|
6.08 months
Interval 5.49 to 20.09
|
Adverse Events
AZD-1775 100 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
AZD-1775 125 mg
Serious events: 5 serious events
Other events: 3 other events
Deaths: 9 deaths
AZD-1775 150 mg
Serious events: 4 serious events
Other events: 3 other events
Deaths: 5 deaths
AZD-1775 175 mg
Serious events: 8 serious events
Other events: 4 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
AZD-1775 100 mg
n=1 participants at risk
AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 125 mg
n=13 participants at risk
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
n=9 participants at risk
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
n=11 participants at risk
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Gastrointestinal disorders
ALT/AST elevation
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Gastrointestinal disorders
Anorexia, nausea/vomiting
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
18.2%
2/11 • Number of events 2 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Gastrointestinal disorders
Cholangitis
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Gastrointestinal disorders
GI bleed
|
100.0%
1/1 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
27.3%
3/11 • Number of events 3 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Blood and lymphatic system disorders
Septic shock
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
27.3%
3/11 • Number of events 3 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
General disorders
Fever
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
General disorders
Altered mental status
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
Other adverse events
| Measure |
AZD-1775 100 mg
n=1 participants at risk
AZD-1775 (MK-1775) 100 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 125 mg
n=13 participants at risk
AZD-1775 (MK-1775) 125 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 150 mg
n=9 participants at risk
AZD-1775 (MK-1775) 150 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
AZD-1775 175 mg
n=11 participants at risk
AZD-1775 (MK-1775) 175 mg will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
Radiation Therapy: 52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy. only in cycles 2 and 3
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritic Rash
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
General disorders
Fever
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/11 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
|
General disorders
Edema
|
0.00%
0/1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/13 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
0.00%
0/9 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the course of treatment (26 weeks). The time frame for data collection for all-cause mortality varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. All-cause mortality includes all observed deaths while the study was ongoing, regardless of duration of patient follow-up. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.
|
Additional Information
Theodore Lawrence, M.D., Ph.D.
University of Michigan Rogel Cancer Center
Phone: 734-647-9955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place