Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Funder reference (academic) | Other Grant/Funding Number | CRUK/10/007 | |
| Funder reference (industry) | Other Grant/Funding Number | ISS05300017 | |
| 2009-017171-13 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Cancer Research UK | OTHER |
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The purpose of this study is to investigate whether the addition of the Src inhibitor saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus placebo, in patients with relapsed platinum-resistant ovarian cancer. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial.
A multicentre, randomised, double-blind, placebo-controlled Phase II trial will be conducted. The overall aim of the trial is to investigate whether the addition of saracatinib to weekly paclitaxel improves efficacy, as measured by progression free survival, compared with paclitaxel plus placebo. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial.
The toxicity data from Study NCT00610714 (D8180C00015) suggests that a small number of patients could experience febrile neutropaenia during their first chemotherapy cycle. To combat this, saracatinib (175 mg OD)/matched placebo will begin 1 week prior to commencement of chemotherapy, and be given continuously until progression.
All patients will receive cycles of weekly paclitaxel chemotherapy. One cycle will consist of weekly paclitaxel (80 mg/m2) for 6 weeks followed by 2 weeks rest. If there is evidence of on-going response after 4 cycles, 3 further cycles of saracatinib/placebo plus weekly paclitaxel 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saracatinib plus weekly paclitaxel | Active Comparator |
| |
| Placebo plus weekly paclitaxel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | First saracatinib/placebo dose until death, assessed up to 36 months | |
| Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria | Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms. |
Not provided
Inclusion criteria:
Exclusion criteria
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Iain McNeish | Barts and the London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrooke's Hospital | Cambridge | Cambridgeshire | BC2 0QQ | United Kingdom | ||
| St Bartholomew's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25070546 | Derived | McNeish IA, Ledermann JA, Webber L, James L, Kaye SB, Hall M, Hall G, Clamp A, Earl H, Banerjee S, Kristeleit R, Raja F, Feeney A, Lawrence C, Dawson-Athey L, Persic M, Khan I. A randomised, placebo-controlled trial of weekly paclitaxel and saracatinib (AZD0530) in platinum-resistant ovarian, fallopian tube or primary peritoneal cancerdagger. Ann Oncol. 2014 Oct;25(10):1988-1995. doi: 10.1093/annonc/mdu363. Epub 2014 Jul 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saracatinib Plus Weekly Paclitaxel | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Saracatinib | Drug | Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression |
|
| Matched placebo | Drug | Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression |
|
| 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. |
| Median Duration of Response | 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. | 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. |
| Quality of Life: Trial Outcome Index (TOI) Based on FACT-O | 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. | 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 |
| Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria | 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. | 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. |
| Median PFS | From first saracatinib/placebo dose to first documented progression and/or death, assessed up to 36 months |
| London |
| Greater London |
| EC1A 7BE |
| United Kingdom |
| University College London Hospital | London | Greater London | NW1 2PG | United Kingdom |
| Guy's Hospital | London | Greater London | SE1 9RT | United Kingdom |
| The Royal Mardsen Hospital | London | Greater London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| Mount Vernon Hospital | Rickmansworth | Middlesex | HA6 2RN | United Kingdom |
| The Churchill Hospital | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| Queen's Hospital | Burton-on-Trent | Staffordshire | DE13 0RB | United Kingdom |
| Royal Marsden Hospital | Sutton | Surrey | SM2 5PT | United Kingdom |
| St James's University Hospital | Leeds | Yorkshire | LS9 7TF | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| FG001 | Placebo Plus Weekly Paclitaxel | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Saracatinib Plus Weekly Paclitaxel | 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 |
| BG001 | Placebo Plus Weekly Paclitaxel | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Cancer Antigen 125 (CA125) | Median | Full Range | U/mL |
| |||||||||||||||
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | 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 | Number | participants |
| |||||||||||||||
| International Federation of Gynecology and Obstetrics(FIGO) Ovarian Cancer Staging at diagnosis | 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 | Number | participants |
| |||||||||||||||
| Histological subtype | Number | participants |
| ||||||||||||||||
| Prior Surgery | Number | participants |
| ||||||||||||||||
| Prior Taxane Interval | Number | participants |
| ||||||||||||||||
| Number of lines of Prior Chemotherapy | Number | participants |
| ||||||||||||||||
| Number of lines of Prior Chemotherapy | Median | Full Range | lines of chemotherapy |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | 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. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Posted | Median | Full Range | months | First saracatinib/placebo dose until death, assessed up to 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria | Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms. | Posted | Number | percentage of participants | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Duration of Response | 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. | Not Posted | 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life: Trial Outcome Index (TOI) Based on FACT-O | 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. | Posted | Mean | Standard Error | units on a scale | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria | 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. | Not Posted | 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median PFS | Posted | Median | 95% Confidence Interval | months | From first saracatinib/placebo dose to first documented progression and/or death, assessed up to 36 months |
|
From trial consent to 30 days after last administration of saracatinib/placebo.
According to Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saracatinib Plus Weekly Paclitaxel | 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 | 40 | 69 | 20 | 69 | ||
| EG001 | Placebo Plus Weekly Paclitaxel | 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 | 18 | 35 | 7 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ventricular arrthymia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Endocarditis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal chest infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Participating sites may not publish trial results without prior written consent from the Trial Management Group
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Iain McNeish, Professor of Gynaecological Oncology | University of Glasgow | +44 (0)141 330 3968 | iain.mcneish@glasgow.ac.uk |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C515233 | saracatinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| 1 |
|
| 2 |
|
| II |
|
| III |
|
| IV |
|
| Unknown |
|
| Low grade serous |
|
| Clear cell |
|
| Grade 3 endometrioid |
|
| Grade 1/2 endometrioid |
|
| Undifferentiated |
|
| Unknown |
|
| No |
|
| Unknown |
|
| >=6 months/None |
|
| >2 |
|
| Unknown |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
| OG001 | Placebo Plus Weekly Paclitaxel | 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 |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|