Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD. | Experimental | Dose escalation of APR-246. |
|
| Phase II: Arm A. APR-246 + Carboplatin/PLD. | Experimental | Experimental |
|
| Phase II: Arm B. Carboplatin/PLD. | Active Comparator | Active Comparator |
|
| Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD. | Experimental | Dose escalation of APR-246. |
|
| Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD. | Experimental | Dose escalation of APR-246. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APR-246 | Drug | Intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Dose-limiting Toxicities (DLT) (See Description) of Combined APR-246 and Carboplatin/PLD Regimen | DLT: Hematological and non-hematological toxicities according to grade/days stated in the protocol. | Until the end of the first treatment cycle, i.e., Day 28 |
| Phase Ib and II: Progression Free Survival (PFS) | Phase Ib: Progression-free Survival is calculated from date of enrollment to the date of disease progression or death due to any cause, whichever occurs first. Symptomatic deterioration is not considered PD. For a patient without evidence of disease progression or death, Progression-free survival will be censored at the date of last evaluable tumor assessment. Patients with no evaluable tumor assessments will be censored at the date of first study drug administration. Phase II: Progression-free survival (PFS) based on Blinded Independent Central Review (BICR) is the primary endpoint and is defined as the number of days from the date of randomization to the date of objective disease progression or relapse (according to RECIST v1.1 only) or death due to any cause, whichever occurs first. If neither event occurs, PFS is censored at the date of the last evaluable tumor assessment. Symptomatic deterioration is not considered objective disease progression. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib and Phase II: Overall Response Rate (RR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22965953 | Background | Lehmann S, Bykov VJ, Ali D, Andren O, Cherif H, Tidefelt U, Uggla B, Yachnin J, Juliusson G, Moshfegh A, Paul C, Wiman KG, Andersson PO. Targeting p53 in vivo: a first-in-human study with p53-targeting compound APR-246 in refractory hematologic malignancies and prostate cancer. J Clin Oncol. 2012 Oct 10;30(29):3633-9. doi: 10.1200/JCO.2011.40.7783. Epub 2012 Sep 10. | |
| 27421096 |
| Label | URL |
|---|---|
| Aprea Therapeutics AB's website (Sponsor) | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| FG001 | Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD) | Drug | Intravenous infusion. |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| UPMC Hillman Cancer Center, Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Parkland, UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Massey Cancer Center, Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Antwerp University Hospital | Antwerp | 2650 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Cliniques Universitaires Saint Luc | Brussels | B-1200 | Belgium |
| Medische oncologie, Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Leuven University Hospitals | Leuven | B-3000 | Belgium |
| Centre Léon Bérard | Lyon | 69373 | France |
| Centre Hospitalier Lyon Sud | Lyon | 69495 | France |
| Centre Catherine de Sienne | Nantes | 44202 | France |
| Institut Curie | Paris | 75005 | France |
| Hôpital des Diaconesses (Site Reuilly) | Paris | 75012 | France |
| Centre Paul Strass | Strasbourg | 67065 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Praxisklinik, Krebsheilkunde für Frauen | Berlin | 10367 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitätsfrauenklinik Ulm | Ulm | 89075 | Germany |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9700 RB | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | 2300 RC | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 HX | Netherlands |
| Institut Català d'Oncologia, Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Centro Oncologico MD Anderson | Madrid | 28033 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundación Jiménez DÃaz | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario Araba | Vitoria-Gasteiz | 01009 | Spain |
| Hospital ClÃnico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Karolinska University Hospital | Stockholm | SE-171 76 | Sweden |
| Bristol Haematology & Oncology Centre, University Hospitals Bristol | Bristol | BS2 8ED | United Kingdom |
| Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Edinburgh Cancer Research Centre, The University of Edinburgh | Edinburgh | EH4 2XR | United Kingdom |
| The Clatterbridge Cancer Center NHS Foundation Trust | Liverpool | CH63 4JY | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SM2 5PT | United Kingdom |
| Imperial College London, Hammersmith Hospital Campus | London | W12 0NN | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Deneberg S, Cherif H, Lazarevic V, Andersson PO, von Euler M, Juliusson G, Lehmann S. An open-label phase I dose-finding study of APR-246 in hematological malignancies. Blood Cancer J. 2016 Jul 15;6(7):e447. doi: 10.1038/bcj.2016.60. No abstract available. |
Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| FG002 | Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| FG003 | Phase II: Arm A. APR-246 + Carboplatin/PLD. | Experimental APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| FG004 | Phase II: Arm B. Carboplatin/PLD. | Active Comparator Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| COMPLETED |
|
| NOT COMPLETED |
|
A total of 36 pts in Ph1b, and 211 patients in Ph2 were enrolled. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating treatment. Another patient in the 67.5 mg/kg dose cohort did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| BG001 | Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| BG002 | Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| BG003 | Phase II: Arm A. APR-246 + Carboplatin/PLD. | Experimental APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| BG004 | Phase II: Arm B. Carboplatin/PLD. | Active Comparator Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| BG005 | 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, Categorical | 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision. | Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study. | Number | 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 | Phase Ib: Dose-limiting Toxicities (DLT) (See Description) of Combined APR-246 and Carboplatin/PLD Regimen | DLT: Hematological and non-hematological toxicities according to grade/days stated in the protocol. | Posted | Count of Participants | Participants | Until the end of the first treatment cycle, i.e., Day 28 |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Phase Ib and II: Progression Free Survival (PFS) | Phase Ib: Progression-free Survival is calculated from date of enrollment to the date of disease progression or death due to any cause, whichever occurs first. Symptomatic deterioration is not considered PD. For a patient without evidence of disease progression or death, Progression-free survival will be censored at the date of last evaluable tumor assessment. Patients with no evaluable tumor assessments will be censored at the date of first study drug administration. Phase II: Progression-free survival (PFS) based on Blinded Independent Central Review (BICR) is the primary endpoint and is defined as the number of days from the date of randomization to the date of objective disease progression or relapse (according to RECIST v1.1 only) or death due to any cause, whichever occurs first. If neither event occurs, PFS is censored at the date of the last evaluable tumor assessment. Symptomatic deterioration is not considered objective disease progression. | Ph Ib = Efficacy Evaluable Ph II = ITT | Posted | Median | 95% Confidence Interval | days | Up to 24 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Phase Ib and Phase II: Overall Response Rate (RR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Phase Ib = Efficacy Evaluable population Phase II = ITT population | Posted | Count of Participants | Participants | Up to 24 months |
|
TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase:
n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg
Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication [APR-246, carboplatin, or PLD], regardless of duration of treatment.
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 | Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg | 4 | 9 | 3 | 9 | 9 | 9 |
| EG001 | Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg | 3 | 6 | 4 | 6 | 6 | 6 |
| EG002 | Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg | 10 | 20 | 12 | 20 | 20 | 20 |
| EG003 | Phase II: Arm A. APR-246 + Carboplatin/PLD. | Experimental APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. | 0 | 99 | 31 | 99 | 99 | 99 |
| EG004 | Phase II: Arm B. Carboplatin/PLD. | Active Comparator Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. | 2 | 101 | 17 | 101 | 101 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Palpitations | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Advisor | Aprea Therapeutics | 215-948-4119 | info@aprea.com |
| Jun 1, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C533410 | eprenetapopt |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Sweden |
|
| Belgium |
|
| United States |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| Spain |
|
| OG002 | Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD. | Dose escalation of APR-246. APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| OG003 | Phase II: Arm A. APR-246 + Carboplatin/PLD. | Experimental APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| OG004 | Phase II: Arm B. Carboplatin/PLD. | Active Comparator Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
|
|
| OG003 |
| Phase II: Arm A. APR-246 + Carboplatin/PLD. |
Experimental APR-246: Intravenous infusion. Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
| OG004 | Phase II: Arm B. Carboplatin/PLD. | Active Comparator Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion. |
|
|