Trial Outcomes & Findings for SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT00337194)
NCT ID: NCT00337194
Last Updated: 2015-02-23
Results Overview
The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): \>= 50% reduction in sum of the product of diameters of indicator lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 10 years
Results posted on
2015-02-23
Participant Flow
From April 2006 to December 2007 10 institutions recruited 30 participants to this trial.
Participant milestones
| Measure |
Arm I (SGN-30, Chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
7
|
|
Overall Study
COMPLETED
|
11
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
Reasons for withdrawal
| Measure |
Arm I (SGN-30, Chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Disease progression
|
1
|
2
|
|
Overall Study
Subsequent non-protocol therapy
|
3
|
1
|
Baseline Characteristics
SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Arm I (SGN-30, Chemotherapy)
n=23 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=7 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
n=99 Participants
|
38 years
n=107 Participants
|
35 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
7 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Prior autologous transplant
Yes
|
8 participants
n=99 Participants
|
3 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Prior autologous transplant
No
|
15 participants
n=99 Participants
|
4 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 10 yearsThe number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): \>= 50% reduction in sum of the product of diameters of indicator lesions.
Outcome measures
| Measure |
Arm I (SGN-30, Chemotherapy)
n=23 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=7 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Number of Participants With Overall Response (OR)
|
15 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Up to 10 yearsEvent free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm I (SGN-30, Chemotherapy)
n=23 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=7 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Event Free Survival (EFS)
|
11.3 months
Interval 4.7 to
he upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
4.1 months
Interval 1.8 to
he upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: 1 yearPercentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm I (SGN-30, Chemotherapy)
n=23 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=7 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Overall Survival (OS) At 1 Year
|
86 percentage of participants
Interval 61.0 to 95.0
|
30 percentage of participants
Interval 13.0 to 72.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 21 of course 6Population: Data was only available on 10 participants from Arm 1. (No participants from Arm II were evaluable for this endpoint as they did not receive SGN-30 per protocol.)
Record the highest serum level of monoclonal antibody SGN-30 achieved.
Outcome measures
| Measure |
Arm I (SGN-30, Chemotherapy)
n=10 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Peak Serum Level of Monoclonal Antibody SGN-30
|
339 mg/ml
Interval 141.0 to 565.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 21 of course 6Population: Nine participants submitted pretreatment sCD30 samples.
A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups.
Outcome measures
| Measure |
Arm I (SGN-30, Chemotherapy)
n=4 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=5 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
sCD30 Levels
|
174.2 U/ml
Interval 14.3 to 1992.0
|
76.5 U/ml
Interval 21.0 to 219.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Fc gamma receptor polymorphisms were assessed in 28 participants.
Fisher's exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a
Outcome measures
| Measure |
Arm I (SGN-30, Chemotherapy)
n=17 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=11 Participants
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Fc Gamma Receptor Polymorphisms
F/V
|
7 participants
|
5 participants
|
|
Fc Gamma Receptor Polymorphisms
V/V
|
0 participants
|
0 participants
|
|
Fc Gamma Receptor Polymorphisms
F/F
|
10 participants
|
6 participants
|
Adverse Events
Arm I (SGN-30, Chemotherapy)
Serious events: 9 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm II (Placebo, Chemotherapy)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (SGN-30, Chemotherapy)
n=23 participants at risk
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=7 participants at risk
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharma
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
26.1%
6/23 • Number of events 6
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ileus
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Mucositis oral
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Stomach pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
General disorders
Chest pain
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
General disorders
Chills
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Edema limbs
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Fatigue
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
General disorders
Fever
|
17.4%
4/23 • Number of events 4
|
0.00%
0/7
|
|
General disorders
Visceral edema
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Infection
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Sepsis
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Alanine aminotransferase increased
|
17.4%
4/23 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
26.1%
6/23 • Number of events 6
|
0.00%
0/7
|
|
Investigations
Blood bilirubin increased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Creatinine increased
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Investigations
INR increased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Laboratory test abnormal
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Leukocyte count decreased
|
17.4%
4/23 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Investigations
Neutrophil count decreased
|
21.7%
5/23 • Number of events 5
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Platelet count decreased
|
17.4%
4/23 • Number of events 4
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
17.4%
4/23 • Number of events 4
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
17.4%
4/23 • Number of events 4
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Dysgeusia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.4%
4/23 • Number of events 4
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
17.4%
4/23 • Number of events 4
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Body odor
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
Other adverse events
| Measure |
Arm I (SGN-30, Chemotherapy)
n=23 participants at risk
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo, Chemotherapy)
n=7 participants at risk
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharma
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.7%
2/23 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
65.2%
15/23 • Number of events 31
|
71.4%
5/7 • Number of events 8
|
|
Blood and lymphatic system disorders
Hemolysis
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Cardiac pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Edema
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Palpitations
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Ear pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Eye disorders
Vision blurred
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
21.7%
5/23 • Number of events 6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1
|
28.6%
2/7 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
17.4%
4/23 • Number of events 5
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ileus
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Mucositis oral
|
21.7%
5/23 • Number of events 5
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23 • Number of events 16
|
57.1%
4/7 • Number of events 5
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/23
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 2
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Chest pain
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
General disorders
Chills
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
General disorders
Edema limbs
|
13.0%
3/23 • Number of events 6
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Fatigue
|
34.8%
8/23 • Number of events 13
|
85.7%
6/7 • Number of events 6
|
|
General disorders
Fever
|
21.7%
5/23 • Number of events 6
|
0.00%
0/7
|
|
General disorders
Joint- Late RT Morbidity Scoring
|
4.3%
1/23 • Number of events 2
|
0.00%
0/7
|
|
General disorders
Localized edema
|
0.00%
0/23
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Pain
|
8.7%
2/23 • Number of events 3
|
0.00%
0/7
|
|
General disorders
Visceral edema
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Immune system disorders
Hypersensitivity
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Catheter related infection
|
4.3%
1/23 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Skin infection
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Upper aerodigestive tract infection
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.3%
1/23 • Number of events 4
|
0.00%
0/7
|
|
Investigations
Alanine aminotransferase increased
|
39.1%
9/23 • Number of events 12
|
57.1%
4/7 • Number of events 6
|
|
Investigations
Alkaline phosphatase increased
|
17.4%
4/23 • Number of events 6
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
34.8%
8/23 • Number of events 12
|
42.9%
3/7 • Number of events 5
|
|
Investigations
Coagulopathy
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Creatinine increased
|
4.3%
1/23 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
INR increased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Leukocyte count decreased
|
43.5%
10/23 • Number of events 15
|
57.1%
4/7 • Number of events 7
|
|
Investigations
Lymphocyte count decreased
|
30.4%
7/23 • Number of events 11
|
28.6%
2/7 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
69.6%
16/23 • Number of events 21
|
85.7%
6/7 • Number of events 8
|
|
Investigations
Platelet count decreased
|
69.6%
16/23 • Number of events 32
|
42.9%
3/7 • Number of events 7
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
3/23 • Number of events 3
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
13.0%
3/23 • Number of events 5
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
21.7%
5/23 • Number of events 9
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
17.4%
4/23 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/23
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
13.0%
3/23 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
3/23 • Number of events 5
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
4.3%
1/23 • Number of events 2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23 • Number of events 3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.4%
4/23 • Number of events 5
|
0.00%
0/7
|
|
Nervous system disorders
Tremor
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Agitation
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
8.7%
2/23 • Number of events 2
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
13.0%
3/23 • Number of events 3
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/23
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
3/23 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.1%
6/23 • Number of events 8
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23
|
14.3%
1/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/23
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
34.8%
8/23 • Number of events 16
|
28.6%
2/7 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
2/23 • Number of events 4
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
13.0%
3/23 • Number of events 3
|
14.3%
1/7 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Sweating
|
8.7%
2/23 • Number of events 6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.3%
1/23 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Number of events 2
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60