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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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.
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States
NIH, Center for Cancer Research, Medical Oncology
Bethesda, Maryland, United States
Hopital Larrey
Toulouse, France
Institut de cancerologie Gustave Roussy
Villejuif, France
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
Time frame: 3 months since treatment start
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.
Time frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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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Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, (MI), Italy
Azienda Ospedaliera San Luigi Gonzaga
Orbassano, Italy
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.
Time frame: 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.
Time frame: 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.