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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014338-79 | EudraCT Number |
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For the 2 last patients still on treated nominal therapeutic use of the Milciclib was approved at INT Milano.
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The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.
The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase II clinical trial of PHA-848125AC administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. The primary end point for this study is a progression free survival rate of 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milciclib Maleate (PHA-848125AC) | Experimental | 100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milciclib Maleate | Drug | 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate at 3 Months | The proportion of successes (i.e. patients alive and progression free at 3 months since treatment start) out of the total number of evaluable patients | 3 months since treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) | Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1) The analysis was performed in the evaluable population. | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glen Weiss, MD | Scottsdale Clinical Research Institute, USA | Principal Investigator |
| Benjamin Besse, MD | Institut Gustave Roussy, Villejuif, France | Principal Investigator |
| Julien Mazières, MD | Hopital Larrey CHU, Toulouse, France | Principal Investigator |
| Silvia Novello, MD | Ospedale San Luigi Gonzaga, Orbassano, Italy | Principal Investigator |
| Arun Rajan, MD. | National Cancer Institute (NCI) | Principal Investigator |
| Marina C Garassino, MD | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
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Subjects were enrolled from 22 February 2010 to 05 April 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Milciclib Maleate (PHA-848125AC) | 100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Milciclib Maleate (PHA-848125AC) | 100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity. |
| 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 | Progression-free Survival Rate at 3 Months | The proportion of successes (i.e. patients alive and progression free at 3 months since treatment start) out of the total number of evaluable patients | Evaluable patients: population consisting of all treated patients who fulfill the following conditions:
| Posted | Count of Participants | Participants | 3 months since treatment start |
|
Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 4.8 weeks to 281.7 weeks with a median of 24.07 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milciclib Maleate (PHA-848125AC) | 100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cristina Davite | CLIOSS S.r.l. | +39 0031 58 | 1482 | regulatory@clioss.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2017 | May 22, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: CDKO-125a-006_ALG_V1 | Jul 8, 2013 | May 22, 2018 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: CDKO-125a-006_TLG_V1 | Jul 8, 2013 | May 22, 2018 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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| ID | Term |
|---|---|
| C550092 | N,1,4,4-tetramethyl-8-((4-(4-methylpiperazin-1-yl)phenyl)amino)-4,5-dihydro-1H-pyrazolo(4,3-h)quinazoline-3-carboxamide |
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|
| Disease Control Rate | Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD>/= 6 weeks). The analysis was performed in the evaluable populations. | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
| Progression-free Survival | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
| Duration of Response | Assessed in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria. | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
| Overall Survival | The length of time from the start of treatment for a disease, such as cancer, to the date in which the patients diagnosed with the disease were still alive. | Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug. |
| Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) | The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment. Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities was evaluated by considering the worst occurrence for each patient throughout the whole treatment period. | Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles. |
| NIH, Center for Cancer Research, Medical Oncology |
| Bethesda |
| Maryland |
| 20892 |
| United States |
| Hopital Larrey | Toulouse | 31059 | France |
| Institut de cancerologie Gustave Roussy | Villejuif | 94805 | France |
| Fondazione IRCCS Istituto Nazionale dei Tumori di Milano | Milan | (MI) | 20133 | Italy |
| Azienda Ospedaliera San Luigi Gonzaga | Orbassano | 10043 | Italy |
| Sponsor's decision |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| WHO - Classification | Count of Participants | Participants |
|
| Tumor extent at study entry | Count of Participants | Participants |
|
| Masaoka clinical staging at study entry | Staging used to evaluate invasiveness of the tumor. | Count of Participants | Participants |
|
|
|
|
| Secondary | Confirmed Objective Response Rate (ORR) | Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1) The analysis was performed in the evaluable population. | Evaluable patients | Posted | Number | 95% Confidence Interval | Percentage of patients | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
|
|
|
| Secondary | Disease Control Rate | Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD>/= 6 weeks). The analysis was performed in the evaluable populations. | Evaluable patients | Posted | Number | 95% Confidence Interval | Percentage of patients | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
|
|
|
| Secondary | Progression-free Survival | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. | Evaluable patients | Posted | Median | 95% Confidence Interval | Months | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
|
|
|
| Secondary | Duration of Response | Assessed in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria. | Posted | Median | 95% Confidence Interval | Months | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. |
|
|
|
| Secondary | Overall Survival | The length of time from the start of treatment for a disease, such as cancer, to the date in which the patients diagnosed with the disease were still alive. | Evaluable patients | Posted | Median | 95% Confidence Interval | Months | Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug. |
|
|
|
| Secondary | Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) | The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment. Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities was evaluated by considering the worst occurrence for each patient throughout the whole treatment period. | All treated patients | Posted | Count of Participants | Participants | Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles. |
|
|
|
| 37 |
| 72 |
| 22 |
| 72 |
| 72 |
| 72 |
| Cerebral ischaemia | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Epilepsy NOS | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Myasthenic syndrome | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Neuralgia NOS | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Neurological symptoms | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Bronchitis NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Red cell aplasia | Blood and lymphatic system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Biliary dilatation | Hepatobiliary disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Infection NOS | Infections and infestations | MedDRA (5.1) | Non-systematic Assessment |
|
| Dehydratation | Metabolism and nutrition disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Superior vena caval occclusion | Vascular disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Mucosal imflammation | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Rigors | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Dysphonia | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Rhinitis NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (5.1) | Non-systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA (5.1) | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (5.1) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (5.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (5.1) | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Visual disturbance NOS | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Leukopenia NOS | Blood and lymphatic system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Anaemia NOS | Blood and lymphatic system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Sweating increased | Skin and subcutaneous tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (5.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (5.1) | Non-systematic Assessment |
|
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Title | Measurements |
|---|---|
|