Trial Outcomes & Findings for Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer (NCT NCT01109524)
NCT ID: NCT01109524
Last Updated: 2015-12-24
Results Overview
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Day 1 up to 30 days after last dose
Results posted on
2015-12-24
Participant Flow
First participant, first visit: 1 July 2010; Last participant, last visit: 7 September 2012. Participants were chemotherapy-naive with Stage IV histologically or cytologically documented non-small cell lung cancer (NSCLC). Participants treated until: progressive disease (PD)/ toxicity/patient-investigator decision.
72 participants were enrolled and 60 were treated with study drug. 12 not treated: 10 participants no longer met study criteria and 2 participants withdrew consent before entering the treatment phase.
Participant milestones
| Measure |
Cetuximab + Cisplatin/Vinorelbine
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Cetuximab + Cisplatin/Vinorelbine
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
No longer meets criteria
|
2
|
|
Overall Study
Disease Progression
|
29
|
|
Overall Study
Study Drug toxicity
|
6
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Maximum clinical benefit
|
3
|
|
Overall Study
Participant requested to end treatment
|
4
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=60 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=5 Participants
|
|
ECOG PS at baseline
0
|
17 Participants
n=5 Participants
|
|
ECOG PS at baseline
1
|
38 Participants
n=5 Participants
|
|
ECOG PS at baseline
2
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dosePopulation: Treated population: all participants who received at least one dose of any study drug.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=60 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Deaths due to disease progression
|
3 participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Deaths due to Other Causes
|
2 participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
SAE (any grade)
|
38 participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
AE (any grade)
|
59 participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
AE Grade 3 or 4
|
46 participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
AE that led to Discontinuation of study drug
|
21 participants
|
PRIMARY outcome
Timeframe: Day 1 to 30 days after last dosePopulation: Treated population: all participants who received at least one dose of any study drug.
Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=60 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Grade 3-4 acneform rash
|
5 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Grade 3-4 infusion reaction
|
2 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Cardiac events Grade 3-4
|
3 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Infection Grade 3-4
|
9 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Sepsis Grade 3-4
|
0 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Renal failure Grade 3-4
|
3 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Thromboembolic events Grade 3-4
|
11 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Interstitial lung disease Grade 3-4
|
0 participants
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Febrile neutropenia Grade 3-4
|
6 participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dosePopulation: Number (N) of participants with laboratory data available and who could be analyzed for total bilirubin was 49. All other liver function laboratories N=57. Treated population: all participants who received at least one dose of any study drug.
ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:\>ULN 2.5\*ULN; Grade 2: \>2.5 - 5.0\*ULN; Grade 3: \>5.0 - 20.0\*ULN; Grade 4: \>20.0\*ULN. AST Grade 1: \>ULN - 2.5\*ULN; Grade 2: \>2.5 - 5.0\*ULN; Grade 3: \>5.0 - 20.0\*ULN; Grade 4: \>20.0\*ULN. Total bilirubin Grade 1: \>ULN - 1.5\*ULN; Grade 2: \>1.5 - 3.0\*ULN; Grade 3: \>3.0 - 10.0\*ULN; Grade 4: \>10.0\*ULN. Albumin (low) Grade 1:\<LLN - 3 grams per deciliter (g/dL)to \<LLN - 3 g/dL; Grade 2: \<3 - 2 g/dL to \< 3.0 - 2.0 g/dL; Grade 3: \< 2 g/dL to \<2 g/L. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=57 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
Albumin (low) Grade 1 - 4
|
37 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
Albumin (low) Grade 3 or 4
|
0 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
Total bilirubin (high) Grade 1 - 4 (N=49)
|
3 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
Total bilirubin (high) Grade 3 or 4 (N=49)
|
0 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
ALT (high) Grade 1 - 4
|
31 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
ALT (high) Grade 3 or 4
|
0 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
ALP (high) Grade 1 - 4
|
26 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
ALP (high) Grade 3 or 4
|
0 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
AST (high) Grade 1 - 4
|
19 participants
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
AST (high) Grade 3 or 4
|
0 participants
|
PRIMARY outcome
Timeframe: Day 2 up to 30 days after last dosePopulation: Treated population: all participants who received at least one dose of any study drug. Participants with at least one on-study laboratory measurement available were analyzed.
Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10\^3 /microliter (µL); platelets normal range: 140-450 x 10\^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10\^9/μL.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=57 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Hemoglobin (low) Grade 1 - 4
|
51 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Hemoglobin (low) Grade 3 or 4
|
4 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Hemoglobin (low) Grade 4
|
0 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Platelets (low) Grade 1 - 4
|
19 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Platelets (low) Grade 3 or 4
|
1 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Platelets (low) Grade 4
|
0 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
WBC (low) Grade 1 - 4
|
49 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
WBC (low) Grade 3 or 4
|
28 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
WBC (low) Grade 4
|
6 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
ANC (low) Grade 1 - 4
|
47 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
ANC (low) Grade 3 or 4
|
38 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
ANC (low) Grade 4
|
24 participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dosePopulation: Treated population: All participants who received at least one dose of any study drug.
ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:\>ULN - 150 millimoles per liter (mmol/L); Gr 2: \>150 - 155 mmol/L; Gr 3: \>155 - 160mmol/L; Gr 4: \>160 mmol/L. Sodium low(L) Gr 1:\<LLN - 130mmol/L; Gr 3: \<130 - 120 mmol/L; Gr 4: \<120 mmol/L. Potassium (H) Gr 1: \>ULN - 5.5 mmol/L; Gr 2: \>5.5 - 6.0 mmol/L; Gr 3: \> 6.0 - 7.0 mmol/L; Gr 4: \>7.0 mmol/L. Potassium (L) Gr 1: \<LLN - 3.0 mmol/L; Gr 2: \<LLN - 3.0 mmol/L; Gr 3: \< 3.0 - 2.5 mmol/L; Gr 4: \<2.5 mmol/L. Serum creatinine (H) Gr 1: \>1 - 1.5\*baseline (BL)to \>ULN - 1.5\*ULN; Gr 2: \>1.5 - 3.0\*BL to \> 1.5 - 3.0\*ULN; Gr 3: \>3.0\*BL to \> 3.0 - 6.0\*ULN; Gr 4: \>6.0\*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=57 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Sodium (low) Grade 1 - 4
|
42 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Sodium (low) Grade 3 or 4
|
18 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Sodium (low) Grade 4
|
0 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Sodium (high) Grade 1 - 4
|
1 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Sodium (high) Grade 3 or 4
|
0 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Sodium (high) Grade 4
|
0 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Potassium (low) Grade 1 - 4
|
29 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Potassium (low) Grade 3 or 4
|
12 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Potassium (low) Grade 4
|
1 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Potassium (high) Grade 1 - 4
|
10 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Potassium (high) Grade 3 or 4
|
1 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Potassium (high) Grade 4
|
0 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Serum Creatinine (high) Grade 1 - 4
|
15 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Serum Creatinine (high) Grade 3 or 4
|
0 participants
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Serum Creatinine (high) Grade 4
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dosePopulation: Treated population: All participants who received at least one dose of any study drug.
Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship. AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=60 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Drug-related SAE (any grade)
|
16 participants
|
|
Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Drug-related AE (any grade)
|
54 participants
|
|
Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Drug-related AE Grade 3 or 4
|
31 participants
|
|
Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Drug-related AE led to Discontinuation of drug
|
11 participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dosePopulation: Treated population: All participants who received at least one dose of any study drug.
Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship. Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0). Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less. Day 1=start of study drug; to 30 days after last dose of any treatment.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=60 Participants
Intravenous (IV) cetuximab, 400mg per meter\^2 (m\^2), Week 1, then 250mg/m\^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m\^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m\^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related acneform rash Grade 3 - 4
|
5 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related infusion reaction Grade 3 - 4
|
2 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related cardiac events Grade 3 - 4
|
0 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related infection Grade 3 - 4
|
0 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related sepsis Grade 3 - 4
|
0 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related interstitial lung disease Grade 3 - 4
|
0 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related renal failure Grade 3 - 4
|
2 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related thromboembolic events Grade 3 - 4
|
5 participants
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
drug-related febrile neutropenia Grade 3 - 4
|
4 participants
|
Adverse Events
Cetuximab + Cisplatin/Vinorelbine
Serious events: 38 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=60 participants at risk
Intravenous (IV) cetuximab, 400mg per meter squared (m²), week 1, then 250mg/m² weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped the treatment. One hour of observation required after each infusion. IV cisplatin, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles. Pre-cisplatin hydration could begin during 1-hour post cetuximab observation period. IV vinorelbine, 80mg/m², Day 1 of each 21 day cycle, maximum 6 cycles. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Infections and infestations
Clostridium difficile colitis
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Peritonitis
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Vascular disorders
Thrombophlebitis
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Administration site abscess
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Vascular disorders
Deep vein thrombosis
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Diverticular perforation
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Neutropenic infection
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Cerebral infarction
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
2/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Fatigue
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
13.3%
8/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Disease progression
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Lobar pneumonia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
2/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
2/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Renal and urinary disorders
Renal failure
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Tooth infection
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Asthenia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Mucosal inflammation
|
3.3%
2/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Lung infection pseudomonal
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.7%
1/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
Other adverse events
| Measure |
Cetuximab + Cisplatin/Vinorelbine
n=60 participants at risk
Intravenous (IV) cetuximab, 400mg per meter squared (m²), week 1, then 250mg/m² weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped the treatment. One hour of observation required after each infusion. IV cisplatin, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles. Pre-cisplatin hydration could begin during 1-hour post cetuximab observation period. IV vinorelbine, 80mg/m², Day 1 of each 21 day cycle, maximum 6 cycles. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.7%
7/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
56.7%
34/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Headache
|
23.3%
14/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Psychiatric disorders
Insomnia
|
31.7%
19/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
36.7%
22/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Investigations
Weight decreased
|
25.0%
15/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
9/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Constipation
|
51.7%
31/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.3%
23/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
16/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Immune system disorders
Hypersensitivity
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
26.7%
16/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Localised infection
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
10/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.7%
7/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
16/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Syncope
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.0%
9/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Fatigue
|
61.7%
37/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Eye disorders
Vision blurred
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Psychiatric disorders
Depressed mood
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
41.7%
25/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Eye disorders
Dry eye
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
12/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Vascular disorders
Hot flush
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.7%
7/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Nausea
|
68.3%
41/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Pain
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
16/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Dizziness
|
23.3%
14/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
10/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Nail infection
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Investigations
Neutrophil count
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Oedema
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Oedema peripheral
|
20.0%
12/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Rhinitis
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Asthenia
|
15.0%
9/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Investigations
Blood creatinine increased
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Chills
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
20/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
45.0%
27/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Vascular disorders
Hypotension
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.7%
7/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Mucosal inflammation
|
20.0%
12/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.3%
11/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Pharyngitis
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Pneumonia
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Pyrexia
|
18.3%
11/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Cardiac disorders
Tachycardia
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.7%
13/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
General disorders
Chest pain
|
15.0%
9/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.7%
7/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Infection
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.7%
7/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
20/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Infections and infestations
Paronychia
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Investigations
White blood cell count decreased
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Psychiatric disorders
Anxiety
|
21.7%
13/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Psychiatric disorders
Depression
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
3/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
13.3%
8/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
5/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
4/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
6/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
10/60 • Day 1 up to 30 days after last dose of study drug. Participants were in the study until disease progression or toxicity/decision by patient-investigator.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER