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Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer (SaPPrOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01196741
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
AstraZeneca
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Interventions Drug: Paclitaxel
Drug: Saracatinib
Drug: Matched placebo
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Hide Arm/Group Description

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Period Title: Overall Study
Started 71 36
Completed 11 8
Not Completed 60 28
Reason Not Completed
Disease progression             34             14
Adverse Event             10             6
Serious Adverse Event             3             1
Dose limiting Adverse Event             2             1
Withdrawal by Subject             3             0
Other reason             3             3
Other             3             2
Protocol Violation             2             1
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel Total
Hide Arm/Group Description

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Total of all reporting groups
Overall Number of Baseline Participants 71 36 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 71 participants 36 participants 107 participants
62.8
(34.5 to 78.8)
66.9
(20.0 to 82.1)
63.4
(20.0 to 82.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 36 participants 107 participants
Female
71
 100.0%
36
 100.0%
107
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 71 participants 36 participants 107 participants
71 36 107
Cancer Antigen 125 (CA125)  
Median (Full Range)
Unit of measure:  U/mL
Number Analyzed 71 participants 36 participants 107 participants
628
(8 to 12945)
667
(24 to 7758)
648
(8 to 12945)
Eastern Cooperative Oncology Group Performance Status (ECOG PS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 36 participants 107 participants
0 23 15 38
1 45 20 65
2 3 1 4
[1]
Measure Description:

ECOG PS 0 = Fully active, able to carry out all normal (pre-disease) activity without restriction

ECOG PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out light work, e.g. light house work, office work

ECOG PS 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

International Federation of Gynecology and Obstetrics(FIGO) Ovarian Cancer Staging at diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 36 participants 107 participants
I 6 2 8
II 5 1 6
III 45 31 76
IV 11 1 12
Unknown 4 1 5
[1]
Measure Description:

STAGE I: Tumour confined to ovaries

STAGE II: Tumour involves one or both ovaries with pelvic extension (below the pelvic brim) or primary peritoneal cancer

STAGE III: Tumour involves one or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastasis to the retroperitoneal lymph nodes

STAGE IV: Distant metastasis excluding peritoneal metastasis

Histological subtype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 36 participants 107 participants
High grade serous 46 27 73
Low grade serous 4 2 6
Clear cell 6 1 7
Grade 3 endometrioid 2 2 4
Grade 1/2 endometrioid 3 1 4
Undifferentiated 7 2 9
Unknown 3 1 4
Prior Surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 36 participants 107 participants
Yes 67 31 98
No 2 5 7
Unknown 2 0 2
Prior Taxane Interval  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 36 participants 107 participants
<6 months 15 8 23
>=6 months/None 56 28 84
Number of lines of Prior Chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 36 participants 107 participants
1-2 43 19 62
>2 26 17 43
Unknown 2 0 2
Number of lines of Prior Chemotherapy  
Median (Full Range)
Unit of measure:  Lines of chemotherapy
Number Analyzed 71 participants 36 participants 107 participants
2.0
(1.0 to 7.0)
2.0
(1.0 to 6.0)
2.0
(1.0 to 7.0)
1.Primary Outcome
Title 6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria)
Hide Description

Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.

The 6 month progression-free survival rate will be calculated by the trial statistician during the final analysis.

Time Frame Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Overall Number of Participants Analyzed 69 35
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
29
(22 to 37)
34
(23 to 46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saracatinib Plus Weekly Paclitaxel, Placebo Plus Weekly Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.65 to 1.23
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame First saracatinib/placebo dose until death, assessed up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Overall Number of Participants Analyzed 69 35
Median (Full Range)
Unit of Measure: months
10.1
(8.3 to 16.2)
12.3
(11.0 to 14.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saracatinib Plus Weekly Paclitaxel, Placebo Plus Weekly Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria
Hide Description Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.
Time Frame Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Overall Number of Participants Analyzed 69 35
Measure Type: Number
Unit of Measure: percentage of participants
29 43
4.Secondary Outcome
Title Median Duration of Response
Hide Description

Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.

Duration of Response will be calculated by the trial statistician during the final analysis.

Time Frame Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Quality of Life: Trial Outcome Index (TOI) Based on FACT-O
Hide Description

The TOI value for each patient is derived at each timepoint by calculating the sum of 3 subscales: Physical Well-Being (PWB), Functional Well-Being (FWB), Additional Concerns. Each subscale score is derived from questions with 4 answers (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). In each subscale reversals are performed and the individual question scores added together. This value is then multiplied by the number of questions within the subscale, and divided by the number of questions answered to derive a subscale score. The higher each subscale score, the better the QoL.

PWB 7 questions, lower values=better QoL.

FWB 7 questions, higher values=better QoL.

Additional concerns 11 questions (higher values in 6 questions=better QoL; higher values in 5 questions=worse QoL)

The TOI is reported for each arm based on the average TOI score of each patient calculated across the outcome measure time frame. The higher the TOI, the better the QoL.

Time Frame Patients will fill in FACT-O questionnaires at the following timepoints: baseline; Weeks 1, 3 and 6 of every chemotherapy cycle; at every follow up visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Overall Number of Participants Analyzed 69 35
Mean (Standard Error)
Unit of Measure: units on a scale
66.89  (1.89) 73.10  (2.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saracatinib Plus Weekly Paclitaxel, Placebo Plus Weekly Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0476
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria
Hide Description

Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.

Time To Progression will be calculated by the trial statistician during the final analysis.

Time Frame Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Median PFS
Hide Description [Not Specified]
Time Frame From first saracatinib/placebo dose to first documented progression and/or death, assessed up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Hide Arm/Group Description:

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Overall Number of Participants Analyzed 69 35
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(3.6 to 5.5)
5.3
(3.6 to 7.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saracatinib Plus Weekly Paclitaxel, Placebo Plus Weekly Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Time Frame From trial consent to 30 days after last administration of saracatinib/placebo.
Adverse Event Reporting Description According to Common Terminology Criteria for Adverse Events (CTCAE) v4.0
 
Arm/Group Title Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Hide Arm/Group Description

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

All-Cause Mortality
Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   40/69 (57.97%)   18/35 (51.43%) 
Blood and lymphatic system disorders     
Anemia  1  1/69 (1.45%)  0/35 (0.00%) 
Febrile neutropenia  1  3/69 (4.35%)  0/35 (0.00%) 
Cardiac disorders     
Ventricular arrthymia  1  0/69 (0.00%)  1/35 (2.86%) 
Myocardial infarction  1  1/69 (1.45%)  0/35 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  4/69 (5.80%)  3/35 (8.57%) 
Abdominal pain  1  4/69 (5.80%)  0/35 (0.00%) 
Diarrhea  1  3/69 (4.35%)  2/35 (5.71%) 
Small intestinal obstruction  1  3/69 (4.35%)  1/35 (2.86%) 
Abdominal distension  1  0/69 (0.00%)  1/35 (2.86%) 
Nausea  1  1/69 (1.45%)  1/35 (2.86%) 
General disorders     
Fever  1  3/69 (4.35%)  1/35 (2.86%) 
Fatigue  1  2/69 (2.90%)  1/35 (2.86%) 
Infections and infestations     
Catheter related infection  1  0/69 (0.00%)  1/35 (2.86%) 
Skin infection  1  0/69 (0.00%)  1/35 (2.86%) 
Urinary tract infection  1  1/69 (1.45%)  1/35 (2.86%) 
Endocarditis infective  1  1/69 (1.45%)  0/35 (0.00%) 
Fungal chest infection  1  1/69 (1.45%)  0/35 (0.00%) 
Lung infection  1  1/69 (1.45%)  0/35 (0.00%) 
Investigations     
Neutrophil count decreased  1  2/69 (2.90%)  0/35 (0.00%) 
Creatinine increased  1  1/69 (1.45%)  0/35 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/69 (2.90%)  0/35 (0.00%) 
Anorexia  1  1/69 (1.45%)  0/35 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/69 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  2/69 (2.90%)  1/35 (2.86%) 
Pneumonitis  1  1/69 (1.45%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysesthesia syndrome  1  0/69 (0.00%)  1/35 (2.86%) 
Rash maculo-papular  1  2/69 (2.90%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Saracatinib Plus Weekly Paclitaxel Placebo Plus Weekly Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   20/69 (28.99%)   7/35 (20.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  3/69 (4.35%)  0/35 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  4/69 (5.80%)  3/35 (8.57%) 
Abdominal pain  1  4/69 (5.80%)  0/35 (0.00%) 
Diarrhea  1  3/69 (4.35%)  2/35 (5.71%) 
Small intestinal obstruction  1  3/69 (4.35%)  1/35 (2.86%) 
General disorders     
Fever  1  3/69 (4.35%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Participating sites may not publish trial results without prior written consent from the Trial Management Group
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Iain McNeish, Professor of Gynaecological Oncology
Organization: University of Glasgow
Phone: +44 (0)141 330 3968
EMail: iain.mcneish@glasgow.ac.uk
Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01196741    
Other Study ID Numbers: UCL/09/105
Funder reference (academic) ( Other Grant/Funding Number: CRUK/10/007 )
Funder reference (industry) ( Other Grant/Funding Number: ISS05300017 )
2009-017171-13 ( EudraCT Number )
First Submitted: September 1, 2010
First Posted: September 8, 2010
Results First Submitted: September 18, 2014
Results First Posted: May 5, 2015
Last Update Posted: May 5, 2015