Trial Outcomes & Findings for Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer (NCT NCT00698516)
NCT ID: NCT00698516
Last Updated: 2012-03-27
Results Overview
PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): \>=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
3 months
Results posted on
2012-03-27
Participant Flow
Participant milestones
| Measure |
Topotecan and Bevacizumab
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Topotecan and Bevacizumab
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
|---|---|
|
Overall Study
Study Termination
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Topotecan and Bevacizumab
n=50 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
|---|---|
|
Age Continuous
|
60.8 Years
STANDARD_DEVIATION 10.75 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
43 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
6 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White and Mixed Race
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication
PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): \>=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.
Outcome measures
| Measure |
Topotecan and Bevacizumab
n=50 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
Topotecan and Bevacizumab: Sensitive Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was \>90 days; therefore, these participants were termed "sensitive".
|
Topotecan and Bevacizumab: All Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
|
|---|---|---|---|
|
Percentage of Participants With Progression-free Survival (PFS) at 3 Months
|
65 percentageof participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)Population: ITT Population
Progression-free survival at any site was defined as the time from initiation of investigational product to the time of first documented disease progression or death due to any cause. Progression was assessed using the RECIST guidelines: \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion (s). For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.
Outcome measures
| Measure |
Topotecan and Bevacizumab
n=23 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
Topotecan and Bevacizumab: Sensitive Participants
n=27 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was \>90 days; therefore, these participants were termed "sensitive".
|
Topotecan and Bevacizumab: All Participants
n=50 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
|
|---|---|---|---|
|
PFS - Overall
|
12.64 weeks
Interval 6.43 to 21.43
|
27.14 weeks
Interval 16.14 to 32.57
|
17.43 weeks
Interval 13.14 to 25.0
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)Population: ITT Population
Tumor response was determined using the RECIST guidelines.CR, disappearance of all target lesions; PR, \>=30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since treatment started; PD, \>=20% increase in sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Topotecan and Bevacizumab
n=23 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
Topotecan and Bevacizumab: Sensitive Participants
n=27 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was \>90 days; therefore, these participants were termed "sensitive".
|
Topotecan and Bevacizumab: All Participants
n=50 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
|
|---|---|---|---|
|
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
CR
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
PR
|
2 participants
|
6 participants
|
8 participants
|
|
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
SD
|
9 participants
|
11 participants
|
20 participants
|
|
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
PD
|
9 participants
|
4 participants
|
13 participants
|
|
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Unknown
|
3 participants
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)Population: ITT Population
Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: \>=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Topotecan and Bevacizumab
n=23 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
Topotecan and Bevacizumab: Sensitive Participants
n=27 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was \>90 days; therefore, these participants were termed "sensitive".
|
Topotecan and Bevacizumab: All Participants
n=50 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
|
|---|---|---|---|
|
Number of Participants With a Tumor Response (CR and PR)
|
2 participants
|
6 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)Population: Participants from the ITT Population who had CR and PR
Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: \>=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Duration of response is defined as the time from start of response (CR or PR) until progression or death due to any cause. For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.
Outcome measures
| Measure |
Topotecan and Bevacizumab
n=8 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
Topotecan and Bevacizumab: Sensitive Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was \>90 days; therefore, these participants were termed "sensitive".
|
Topotecan and Bevacizumab: All Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
|
|---|---|---|---|
|
Duration of Tumor Response (CR and PR)
|
20.6 weeks
Interval 15.6 to 41.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)Population: Participants from the ITT Population who had CR and PR
Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: \>=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Time to response is defined as the time from initiation of investigational product to the time of first documented response (CR or PR).
Outcome measures
| Measure |
Topotecan and Bevacizumab
n=8 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
Topotecan and Bevacizumab: Sensitive Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was \>90 days; therefore, these participants were termed "sensitive".
|
Topotecan and Bevacizumab: All Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
|
|---|---|---|---|
|
Time to Tumor Response (CR and PR)
|
5.8 weeks
Interval 5.3 to 12.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death (up to 82.4 weeks)Population: ITT Population
Overall survival is defined as the time from initiation of investigational product to death due to any cause. For participants who did not die, the time of last contact was used.
Outcome measures
| Measure |
Topotecan and Bevacizumab
n=23 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles.
|
Topotecan and Bevacizumab: Sensitive Participants
n=27 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was \>90 days; therefore, these participants were termed "sensitive".
|
Topotecan and Bevacizumab: All Participants
n=50 Participants
Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m\^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline's study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
|
|---|---|---|---|
|
Overall Survival
|
26.4 weeks
Interval 18.1 to 38.0
|
37.0 weeks
Interval 30.6 to 48.0
|
32.0 weeks
Interval 26.4 to 39.3
|
Adverse Events
Topotecan and Bevacizumab
Serious events: 18 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topotecan and Bevacizumab
n=50 participants at risk
Participants were to receive oral topotecan 2.3 mg/m\^2/day for 5 consecutive days (Days 1 to 5) and IV bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GSK's study physician was needed for subjects who required treatment beyond 8 cycles.
|
|---|---|
|
Infections and infestations
Pneumonia
|
8.0%
4/50
|
|
Infections and infestations
Sepsis
|
4.0%
2/50
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50
|
|
Infections and infestations
Neutropenic infection
|
2.0%
1/50
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
2/50
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50
|
|
General disorders
Asthenia
|
2.0%
1/50
|
|
General disorders
Chest pain
|
2.0%
1/50
|
|
General disorders
Fatigue
|
2.0%
1/50
|
|
General disorders
Pain
|
2.0%
1/50
|
|
General disorders
Pyrexia
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
2/50
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
2/50
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
1/50
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
3/50
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
1/50
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/50
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.0%
1/50
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
1/50
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
4.0%
2/50
|
|
Psychiatric disorders
Depression
|
2.0%
1/50
|
|
Psychiatric disorders
Mental status changes
|
2.0%
1/50
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50
|
|
Nervous system disorders
Depressed level of consciousness
|
2.0%
1/50
|
|
Nervous system disorders
Somnolence
|
2.0%
1/50
|
Other adverse events
| Measure |
Topotecan and Bevacizumab
n=50 participants at risk
Participants were to receive oral topotecan 2.3 mg/m\^2/day for 5 consecutive days (Days 1 to 5) and IV bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GSK's study physician was needed for subjects who required treatment beyond 8 cycles.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
60.0%
30/50
|
|
Gastrointestinal disorders
Diarrhoea
|
54.0%
27/50
|
|
Gastrointestinal disorders
Vomiting
|
38.0%
19/50
|
|
Gastrointestinal disorders
Constipation
|
34.0%
17/50
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
6/50
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
4/50
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
4/50
|
|
Gastrointestinal disorders
Oral pain
|
6.0%
3/50
|
|
General disorders
Fatigue
|
64.0%
32/50
|
|
General disorders
Asthenia
|
24.0%
12/50
|
|
General disorders
Pain
|
8.0%
4/50
|
|
General disorders
Chills
|
6.0%
3/50
|
|
General disorders
Gait disturbance
|
6.0%
3/50
|
|
General disorders
Pyrexia
|
6.0%
3/50
|
|
Blood and lymphatic system disorders
Anaemia
|
54.0%
27/50
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.0%
22/50
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
42.0%
21/50
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.0%
11/50
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.0%
3/50
|
|
Metabolism and nutrition disorders
Decreased appetite
|
48.0%
24/50
|
|
Metabolism and nutrition disorders
Dehydration
|
28.0%
14/50
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.0%
7/50
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.0%
6/50
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
4/50
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
15/50
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.0%
14/50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.0%
13/50
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.0%
6/50
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
4/50
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
8/50
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
5/50
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.0%
4/50
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.0%
3/50
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
3/50
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.0%
3/50
|
|
Nervous system disorders
Dizziness
|
20.0%
10/50
|
|
Nervous system disorders
Headache
|
20.0%
10/50
|
|
Nervous system disorders
Dysgeusia
|
12.0%
6/50
|
|
Psychiatric disorders
Anxiety
|
12.0%
6/50
|
|
Psychiatric disorders
Insomnia
|
12.0%
6/50
|
|
Psychiatric disorders
Confusional state
|
10.0%
5/50
|
|
Psychiatric disorders
Depression
|
8.0%
4/50
|
|
Investigations
Weight decreased
|
16.0%
8/50
|
|
Investigations
Platelet count decreased
|
8.0%
4/50
|
|
Infections and infestations
Urinary tract infection
|
8.0%
4/50
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
3/50
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
3/50
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.0%
6/50
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
4/50
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
3/50
|
|
Vascular disorders
Hypotension
|
6.0%
3/50
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER