Trial Outcomes & Findings for A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer (NCT NCT01763645)
NCT ID: NCT01763645
Last Updated: 2024-01-11
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
353 participants
Primary outcome timeframe
Day 127
Results posted on
2024-01-11
Participant Flow
343 of 353 patients received at least one dose of the study drug/comparator. 10 patients discontinued the study without receiving a single dose of the study drug/comparator. The safety analysis included all data from all randomized subjects who received at least one dose of study therapy, 2 of 343 patients were excluded from the efficacy analysis due to screening failure (1 in each group), n= 341.
Participant milestones
| Measure |
BCD-021 (CISC BIOCAD)
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
142
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
206
|
137
|
|
Overall Study
COMPLETED
|
87
|
56
|
|
Overall Study
NOT COMPLETED
|
124
|
86
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 of 343 participants were excluded from the analysis due to screening failure (1 in each group). 341 participants were analyzed (205 participants in BCD-021 group and 136 participants in Avastin group)
Baseline characteristics by cohort
| Measure |
BCD-021 (CISC BIOCAD)
n=206 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=137 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.79 years
STANDARD_DEVIATION 8.88 • n=206 Participants
|
58.67 years
STANDARD_DEVIATION 8.33 • n=137 Participants
|
58.23 years
STANDARD_DEVIATION 8.61 • n=343 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=205 Participants • 2 of 343 participants were excluded from the analysis due to screening failure (1 in each group). 341 participants were analyzed (205 participants in BCD-021 group and 136 participants in Avastin group)
|
88 Participants
n=136 Participants • 2 of 343 participants were excluded from the analysis due to screening failure (1 in each group). 341 participants were analyzed (205 participants in BCD-021 group and 136 participants in Avastin group)
|
230 Participants
n=341 Participants • 2 of 343 participants were excluded from the analysis due to screening failure (1 in each group). 341 participants were analyzed (205 participants in BCD-021 group and 136 participants in Avastin group)
|
|
Sex: Female, Male
Male
|
63 Participants
n=205 Participants • 2 of 343 participants were excluded from the analysis due to screening failure (1 in each group). 341 participants were analyzed (205 participants in BCD-021 group and 136 participants in Avastin group)
|
48 Participants
n=136 Participants • 2 of 343 participants were excluded from the analysis due to screening failure (1 in each group). 341 participants were analyzed (205 participants in BCD-021 group and 136 participants in Avastin group)
|
111 Participants
n=341 Participants • 2 of 343 participants were excluded from the analysis due to screening failure (1 in each group). 341 participants were analyzed (205 participants in BCD-021 group and 136 participants in Avastin group)
|
PRIMARY outcome
Timeframe: Day 127Population: The efficacy analysis included only those patients who received at least one dose of BCD-021 or Avastin®, and in whom it was possible to assess the response to therapy.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
BCD-021 (CISC BIOCAD)
n=163 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=107 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Overall Response Rate
|
34.63 percentage of participans
|
33.82 percentage of participans
|
PRIMARY outcome
Timeframe: up to Day 22, after the first bevacizumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)Population: Patients who received one dose of study drug and after 504 hours after injection had missed \<= 1 blood sample collection to analyze pharmacokinetics.
primary outcome measure for pharmacokinetics (PK) substudy
Outcome measures
| Measure |
BCD-021 (CISC BIOCAD)
n=111 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=58 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Area Under the Curve After the First Test Drug Administration
|
26951463 (ng/ml)*hour
Interval 6114172.35 to 68355846.0
|
23970112.875 (ng/ml)*hour
Interval 8216733.75 to 80859445.5
|
SECONDARY outcome
Timeframe: Day 127secondary outcome measure for efficacy evaluation
Outcome measures
| Measure |
BCD-021 (CISC BIOCAD)
n=54 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=56 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Complete Response Rate
|
1.85 percentage of patients
Interval 0.33 to 9.77
|
1.79 percentage of patients
Interval 0.32 to 9.45
|
SECONDARY outcome
Timeframe: Day 127secondary outcome measure for efficacy evaluation
Outcome measures
| Measure |
BCD-021 (CISC BIOCAD)
n=54 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=56 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Partial Response Rate
|
40.74 percentage of patients
Interval 28.68 to 54.03
|
37.50 percentage of patients
Interval 26.01 to 50.59
|
SECONDARY outcome
Timeframe: Day 127secondary outcome measure for efficacy evaluation
Outcome measures
| Measure |
BCD-021 (CISC BIOCAD)
n=54 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=56 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Stabilization Rate
|
51.85 percentage of patients
Interval 38.85 to 64.6
|
51.79 percentage of patients
Interval 39.01 to 64.34
|
SECONDARY outcome
Timeframe: Day 127secondary outcome measure for efficacy evaluation
Outcome measures
| Measure |
BCD-021 (CISC BIOCAD)
n=54 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=56 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Progression Rate
|
5.56 percentage of patients
Interval 1.91 to 15.11
|
8.93 percentage of patients
Interval 3.88 to 19.26
|
SECONDARY outcome
Timeframe: Day 1 (before the drug administration), Day 15, 64 and 127Secondary outcome measure for immunogenicity assessment
Outcome measures
| Measure |
BCD-021 (CISC BIOCAD)
n=68 Participants
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=66 Participants
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
|---|---|---|
|
Occurrence of Anti-bevacizumab Antibodies
|
1.47 percentage of patients
|
1.52 percentage of patients
|
Adverse Events
BCD-021 (CISC BIOCAD)
Serious events: 36 serious events
Other events: 206 other events
Deaths: 14 deaths
Avastin (F. Hoffmann-La Roche Ltd)
Serious events: 20 serious events
Other events: 137 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
BCD-021 (CISC BIOCAD)
n=206 participants at risk
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=137 participants at risk
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
2.4%
5/206 • Number of events 5 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
2.2%
3/137 • Number of events 3 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.97%
2/206 • Number of events 2 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Infections and infestations
Pneumonia
|
0.49%
1/206 • Number of events 2 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Infections and infestations
Respiratory tract infection
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Infections and infestations
Gastroenteritis
|
1.5%
3/206 • Number of events 3 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Infections and infestations
Scrotal infection
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
General disorders
Death
|
1.5%
3/206 • Number of events 3 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
1.5%
2/137 • Number of events 2 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
General disorders
Disease progression
|
1.5%
3/206 • Number of events 3 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Gastrointestinal disorders
Proctitis
|
0.97%
2/206 • Number of events 2 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Gastrointestinal disorders
Enteritis
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Vascular disorders
Hypertension
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/206 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.73%
1/137 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.49%
1/206 • Number of events 1 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
0.00%
0/137 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
Other adverse events
| Measure |
BCD-021 (CISC BIOCAD)
n=206 participants at risk
In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug.
|
Avastin (F. Hoffmann-La Roche Ltd)
n=137 participants at risk
In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.5%
104/206 • Number of events 104 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
56.9%
78/137 • Number of events 78 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
29.1%
60/206 • Number of events 60 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
30.7%
42/137 • Number of events 42 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.8%
45/206 • Number of events 45 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
27.0%
37/137 • Number of events 37 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.4%
42/206 • Number of events 42 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
28.5%
39/137 • Number of events 39 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.1%
25/206 • Number of events 25 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
18.2%
25/137 • Number of events 25 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Neutrophilia
|
9.2%
19/206 • Number of events 19 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
19.7%
27/137 • Number of events 27 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.2%
23/206 • Number of events 23 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
13.1%
18/137 • Number of events 18 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Erythropenia
|
8.3%
17/206 • Number of events 17 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
10.9%
15/137 • Number of events 15 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
6.8%
14/206 • Number of events 14 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
12.4%
17/137 • Number of events 17 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
6.3%
13/206 • Number of events 13 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
11.7%
16/137 • Number of events 16 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Blood and lymphatic system disorders
Polycythaemia
|
4.9%
10/206 • Number of events 10 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
2.2%
3/137 • Number of events 3 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.1%
25/206 • Number of events 25 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
14.6%
20/137 • Number of events 20 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Blood alkaline phosphatase increased
|
10.7%
22/206 • Number of events 22 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
13.1%
18/137 • Number of events 18 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Alanine aminotransferase increased
|
9.2%
19/206 • Number of events 19 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
12.4%
17/137 • Number of events 17 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
17/206 • Number of events 17 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
10.2%
14/137 • Number of events 14 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Blood uric acid increased
|
8.7%
18/206 • Number of events 18 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
8.8%
12/137 • Number of events 12 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
White blood cell count decreased
|
9.7%
20/206 • Number of events 20 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
6.6%
9/137 • Number of events 9 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Blood creatinine increased
|
5.8%
12/206 • Number of events 12 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
8.0%
11/137 • Number of events 11 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Blood pressure systolic increased
|
5.8%
12/206 • Number of events 12 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
3.6%
5/137 • Number of events 5 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Investigations
Blood urea increased
|
2.9%
6/206 • Number of events 6 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
8.0%
11/137 • Number of events 11 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
General disorders
Asthenia
|
12.6%
26/206 • Number of events 26 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
12.4%
17/137 • Number of events 17 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
General disorders
Pyrexia
|
11.2%
23/206 • Number of events 23 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
10.2%
14/137 • Number of events 14 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
General disorders
Pain
|
7.8%
16/206 • Number of events 16 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
4.4%
6/137 • Number of events 6 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.7%
53/206 • Number of events 53 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
19.7%
27/137 • Number of events 27 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.9%
39/206 • Number of events 39 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
24.8%
34/137 • Number of events 34 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
22/206 • Number of events 22 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
7.3%
10/137 • Number of events 10 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Gastrointestinal disorders
Nausea
|
6.3%
13/206 • Number of events 13 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
6.6%
9/137 • Number of events 9 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Nervous system disorders
Neuropathy peripheral
|
11.2%
23/206 • Number of events 23 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
11.7%
16/137 • Number of events 16 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
11/206 • Number of events 11 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
5.1%
7/137 • Number of events 7 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
6/206 • Number of events 6 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
5.8%
8/137 • Number of events 8 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
5/206 • Number of events 5 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
5.1%
7/137 • Number of events 7 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Vascular disorders
Hypertension
|
9.7%
20/206 • Number of events 20 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
6.6%
9/137 • Number of events 9 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
|
Cardiac disorders
Tachycardia
|
6.8%
14/206 • Number of events 14 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
5.1%
7/137 • Number of events 7 • 6 therapy cycles
The safety analysis included all subjects who received at least one dose of BCD-021 or Avastin® (n = 343).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place