Trial Outcomes & Findings for A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage (NCT NCT00887159)
NCT ID: NCT00887159
Last Updated: 2021-01-05
Results Overview
Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry
Results posted on
2021-01-05
Participant Flow
Participants were recruited from ECOG member institutions between July, 16, 2009 and August 12, 2011.
Participant milestones
| Measure |
Arm A (CE)
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
cisplatin: Given IV
etoposide: Given IV
|
Arm B (CE+GDC-0449)
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
cisplatin: Given IV
etoposide: Given IV
|
Arm C (CE+IMC-A12)
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
cisplatin: Given IV
etoposide: Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
56
|
|
Overall Study
Patients Who Started Assigned Treatment
|
53
|
53
|
52
|
|
Overall Study
Eligible and Treated Patients
|
48
|
52
|
52
|
|
Overall Study
Eligible/Treated Pts With CTCs Results
|
40
|
42
|
38
|
|
Overall Study
COMPLETED
|
27
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
56
|
56
|
Reasons for withdrawal
| Measure |
Arm A (CE)
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
cisplatin: Given IV
etoposide: Given IV
|
Arm B (CE+GDC-0449)
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
cisplatin: Given IV
etoposide: Given IV
|
Arm C (CE+IMC-A12)
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
cisplatin: Given IV
etoposide: Given IV
|
|---|---|---|---|
|
Overall Study
Disease progression
|
6
|
39
|
33
|
|
Overall Study
Adverse Event
|
3
|
4
|
17
|
|
Overall Study
Death
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
2
|
|
Overall Study
Alternative therapy
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Sympomatic deterioration
|
1
|
0
|
0
|
|
Overall Study
Treatment delayed
|
1
|
1
|
0
|
|
Overall Study
Pt had PD but was SD when re-measured
|
0
|
1
|
0
|
|
Overall Study
Received more tx instead of observation
|
1
|
0
|
0
|
|
Overall Study
Ineligible
|
5
|
1
|
0
|
|
Overall Study
Never started assigned therapy
|
3
|
3
|
4
|
Baseline Characteristics
A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage
Baseline characteristics by cohort
| Measure |
Arm A (CE)
n=48 Participants
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
cisplatin: Given IV
etoposide: Given IV
|
Arm B (CE+GDC-0449)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
cisplatin: Given IV
etoposide: Given IV
|
Arm C (CE+IMC-A12)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
cisplatin: Given IV
etoposide: Given IV
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
63 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
52 participants
n=7 Participants
|
52 participants
n=5 Participants
|
152 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entryPopulation: Eligible and treated patients.
Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.
Outcome measures
| Measure |
Arm A (CE)
n=48 Participants
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (CE+GDC-0449)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
|
Arm C (CE+IMC-A12)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
4.4 months
Interval 3.6 to 5.5
|
4.4 months
Interval 4.1 to 5.4
|
4.6 months
Interval 4.4 to 5.5
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entryPopulation: Eligible and treated patients.
Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).
Outcome measures
| Measure |
Arm A (CE)
n=48 Participants
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (CE+GDC-0449)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
|
Arm C (CE+IMC-A12)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Response Rate
|
0.48 Proportion of patients
Interval 0.33 to 0.63
|
0.56 Proportion of patients
Interval 0.41 to 0.7
|
0.50 Proportion of patients
Interval 0.36 to 0.64
|
SECONDARY outcome
Timeframe: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entryPopulation: Eligible and treated patients.
Overall survival is defined as the time from randomization to death or date of last known alive.
Outcome measures
| Measure |
Arm A (CE)
n=48 Participants
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (CE+GDC-0449)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
|
Arm C (CE+IMC-A12)
n=52 Participants
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival (OS)
|
8.8 months
Interval 7.8 to 11.2
|
9.8 months
Interval 8.7 to 12.4
|
10.1 months
Interval 8.8 to 14.0
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entryPopulation: Eligible and treated patients who had baseline CTC results available for analysis.
Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).
Outcome measures
| Measure |
Arm A (CE)
n=39 Participants
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (CE+GDC-0449)
n=81 Participants
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
|
Arm C (CE+IMC-A12)
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
PFS
|
4.1 months
Interval 3.3 to 5.4
|
4.5 months
Interval 4.4 to 5.3
|
—
|
Adverse Events
Arm A (CE)
Serious events: 45 serious events
Other events: 52 other events
Deaths: 0 deaths
Arm B (CE+GDC-0449)
Serious events: 44 serious events
Other events: 52 other events
Deaths: 0 deaths
Arm C (CE+IMC-A12)
Serious events: 47 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (CE)
n=53 participants at risk
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (CE+GDC-0449)
n=53 participants at risk
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
|
Arm C (CE+IMC-A12)
n=52 participants at risk
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
15.4%
8/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
24.5%
13/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.5%
7/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.1%
8/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
24.5%
13/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
23.1%
12/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.5%
6/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
21.2%
11/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.5%
7/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Lung infection
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Upper respiratory infection
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infections and infestations - Other
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
INR increased
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lipase increased
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
49.1%
26/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
52.8%
28/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
59.6%
31/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
22.6%
12/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
13/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
47.2%
25/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
43.4%
23/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
51.9%
27/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.5%
6/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.5%
7/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective - Other
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Cognitive disturbance
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Delirium
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thromboembolic event
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (CE)
n=53 participants at risk
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (CE+GDC-0449)
n=53 participants at risk
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
|
Arm C (CE+IMC-A12)
n=52 participants at risk
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.5%
6/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
73.6%
39/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
81.1%
43/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
88.5%
46/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limbs
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
71.7%
38/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
86.8%
46/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
80.8%
42/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
69.8%
37/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
64.2%
34/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
76.9%
40/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.5%
6/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.6%
5/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
34.0%
18/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
37.7%
20/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
34.6%
18/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
22.6%
12/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
28.3%
15/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
40.4%
21/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
18.9%
10/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
15.1%
8/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
44.2%
23/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
62.3%
33/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
58.5%
31/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
67.3%
35/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
35.8%
19/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
30.2%
16/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
36.5%
19/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
15.1%
8/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
23.1%
12/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
18.9%
10/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
21.2%
11/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
21.2%
11/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
18.9%
10/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
34.6%
18/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.6%
5/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
22.6%
12/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
26.4%
14/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
21.2%
11/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
52.8%
28/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
43.4%
23/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
65.4%
34/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
37.7%
20/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
49.1%
26/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
67.3%
35/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
56.6%
30/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
35.8%
19/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
59.6%
31/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Investigations - Other, specify
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.6%
5/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
49.1%
26/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
58.5%
31/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
61.5%
32/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
15.1%
8/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
13/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
22.6%
12/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
57.7%
30/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.5%
7/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
20.8%
11/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
30.8%
16/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.0%
9/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
36.5%
19/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.0%
9/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
18.9%
10/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
17.3%
9/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
35.8%
19/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
39.6%
21/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
40.4%
21/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.1%
17/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
26.4%
14/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
32.7%
17/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
15.4%
8/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective - Other
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
15.1%
8/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
17.0%
9/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
13/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
18.9%
10/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
34.0%
18/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
13/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
17.0%
9/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.5%
7/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
18.9%
10/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
15.4%
8/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Blurred vision
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.6%
5/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.5%
4/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.3%
6/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
13.5%
7/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
4/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.7%
3/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.9%
1/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
3.8%
2/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
3/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
13.2%
7/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
9.4%
5/53 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
11.5%
6/52 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-6012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60