Trial Outcomes & Findings for Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors (NCT NCT00561795)
NCT ID: NCT00561795
Last Updated: 2012-03-22
Results Overview
Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the "Adverse Event" section of the results record for additional details and data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline to End of Study (up to a year)
Results posted on
2012-03-22
Participant Flow
Enrollment was to occur in Arm B (Arm A6-1 or A6-2) if \<2 subjects experienced dose-limiting toxicities (DLTs) while on Arm A5-1 or A5-2. After review of data (pre-specified in protocol) ≥2 subjects in Arms A5-1 and A5-2 experienced DLTs; the study was closed and no subjects were enrolled into Arm B. Three ongoing subjects were taken off regimen.
Participant milestones
| Measure |
A5-1
Paclitaxel 175 milligrams (mg)/square meter (m\^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
|
A5-2
Paclitaxel 175 mg/m\^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
|
A6-1
Paclitaxel 175 mg/m\^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
|
A6-2
Paclitaxel 175 mg/m\^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
0
|
0
|
Reasons for withdrawal
| Measure |
A5-1
Paclitaxel 175 milligrams (mg)/square meter (m\^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
|
A5-2
Paclitaxel 175 mg/m\^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
|
A6-1
Paclitaxel 175 mg/m\^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
|
A6-2
Paclitaxel 175 mg/m\^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
0
|
0
|
|
Overall Study
Study Closed/Terminated
|
0
|
3
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors
Baseline characteristics by cohort
| Measure |
A5-1
n=6 Participants
Paclitaxel 175 milligrams (mg)/square meter (m\^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
|
A5-2
n=6 Participants
Paclitaxel 175 mg/m\^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.0 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 9.85 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Study (up to a year)Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the "Adverse Event" section of the results record for additional details and data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until either response or progression (up to 2 years)Although the study protocol specified several efficacy analyses, due to poor tolerability of the combination regimen and the consequent early withdrawal of most participants, which led to a small sample size, efficacy analyses were not performed. Overall response is defined as the number of participants with CR or PR per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until response (up to 2 years)Defined as the number of participants who achieved a confirmed CA-125 response, which is defined as at least a 50% reduction in CA-125 levels from a pre-treatment sample.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 18Defined as the number participants who have not had radiological disease progression per RECIST, confirmed CA-125 progression, or death due to any cause by the end of 18 weeks.
Outcome measures
Outcome data not reported
Adverse Events
A5-1
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
A5-2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A5-1
n=6 participants at risk
Paclitaxel 175 milligrams (mg)/square meter (m\^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
|
A5-2
n=6 participants at risk
Paclitaxel 175 mg/m\^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
83.3%
5/6 • Enrollment to End of Study (up to a year)
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Ileal Perforation
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
General disorders
Fatigue
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Investigations
Haemoglobin Increase
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
Other adverse events
| Measure |
A5-1
n=6 participants at risk
Paclitaxel 175 milligrams (mg)/square meter (m\^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
|
A5-2
n=6 participants at risk
Paclitaxel 175 mg/m\^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Enrollment to End of Study (up to a year)
|
50.0%
3/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Gastric Disorder
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Intestinal Perforation
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Gastrointestinal disorders
Tooth Disorder
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
4/6 • Enrollment to End of Study (up to a year)
|
50.0%
3/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar erythrodysaesthesia syndrome
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
4/6 • Enrollment to End of Study (up to a year)
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
3/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
General disorders
Fatigue
|
66.7%
4/6 • Enrollment to End of Study (up to a year)
|
50.0%
3/6 • Enrollment to End of Study (up to a year)
|
|
General disorders
Mucosal Inflammation
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
General disorders
Pain
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
General disorders
Oedema Peripheral
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
3/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Infections and infestations
Catheter Related Infection
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Investigations
C-Reactive Protein increased
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Investigations
Haemoglobin Decreased
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Investigations
Weight Decreased
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
33.3%
2/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Psychiatric disorders
Nervousness
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Psychiatric disorders
Restlessness
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Psychiatric disorders
Sleep Disorder
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Enrollment to End of Study (up to a year)
|
16.7%
1/6 • Enrollment to End of Study (up to a year)
|
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