Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005557-38 | EudraCT Number |
Not provided
Not provided
Lack of efficacy
Not provided
Not provided
Not provided
Not provided
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This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Vandetanib added to standard therapy (pegliposomal doxorubicin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vandetanib | Drug | 100mg doses orally, once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). | Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3) | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
| Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. | Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening). | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
| Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4. | Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening) | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
| Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4. | Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening). | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
| Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS). | Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ulm | Baden-Wurttemberg | Germany | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24005613 | Derived | Harter P, Sehouli J, Kimmig R, Rau J, Hilpert F, Kurzeder C, Elser G, du Bois A. Addition of vandetanib to pegylated liposomal doxorubicin (PLD) in patients with recurrent ovarian cancer. A randomized phase I/II study of the AGO Study Group (AGO-OVAR 2.13). Invest New Drugs. 2013 Dec;31(6):1499-504. doi: 10.1007/s10637-013-0011-3. Epub 2013 Sep 5. |
Not provided
Not provided
Phase I of the trial consisted of a safety run-in phase of 10 patients with histologically confirmed, epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory or partially sensitive to platinum-based therapy evaluable for at least 2 cycles.
Phase II of the trial was not conducted.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vandetanib 100 mg | Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vandetanib 100 mg | Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). | Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3) | Posted | Number | Participants | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
|
|
Not provided
Not provided
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 | Vandetanib 100 mg | Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C452423 | vandetanib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake) |
| From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
| Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4. | Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening). | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
| From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months. |
| Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS). | Median overall survival (OS) | From date of registration (Informed Consent Form completed) until the date of death. |
| Wiesbaden |
| Hesse |
| Germany |
| Research Site | Essen | North Rhine-Westphalia | Germany |
| Research Site | Kiel | Schleswig-Holstein | Germany |
| Research Site | Berlin | Germany |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS). | Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline. | Posted | Median | 95% Confidence Interval | Months | From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months. |
|
|
|
| Secondary | Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS). | Median overall survival (OS) | Posted | Median | 95% Confidence Interval | Months | From date of registration (Informed Consent Form completed) until the date of death. |
|
|
|
| Primary | Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. | Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening). | Posted | Number | Participants | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
|
|
|
| Primary | Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4. | Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening) | Posted | Number | Participants | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
|
|
|
| Primary | Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4. | Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening). | Posted | Number | Participants | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
|
|
|
| Primary | Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3. | Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake) | Posted | Number | Participants | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
|
|
|
| Primary | Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4. | Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening). | Posted | Number | Participants | From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. |
|
|
|
| 3 |
| 14 |
| 14 |
| 14 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| White blood cell count | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood alkaline phosphatase | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood creatinine | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood glucose | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Monocyte count | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Protein total | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Activated partial thromboplastin time | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood bilirubin | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood calcium | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood chloride | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Blood potassium | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Haematocrit | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Prothrombin time | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Peripheral sensory neuropath | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Chromaturia | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| International normalised ratio | Investigations | MedDRA (13.1) | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| 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 |