Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01301391|
Recruitment Status : Terminated (For the last patient still on treated nominal therapeutic use of the Milciclib was approved at INT Milano.)
First Posted : February 23, 2011
Results First Posted : October 4, 2018
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Thymoma||Drug: Milciclib Maleate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy|
|Actual Study Start Date :||February 2, 2011|
|Actual Primary Completion Date :||May 31, 2017|
|Actual Study Completion Date :||December 17, 2018|
Milciclib Maleate capsules
Drug: 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.
Other Name: PHA-848125AC
- Progression-free Survival Rate at 3 Months [ Time Frame: 3 months since treatment start ]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.
- Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters [ Time Frame: Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 two-week cycles. ]
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 were evaluated by considering the worst occurrence for each patient throughout the whole treatment period.
- Objective Response Rate (ORR) [ Time Frame: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks. ]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.
- Disease Control Rate (ORR+SD Rate) [ Time Frame: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks. ]Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD > or = 6 weeks). The analysis was performed in the evaluable patient populations.
- Duration of Response [ Time Frame: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks. ]Calculated in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.
- Overall Survival [ 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. ]The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, and to the date in which the patients diagnosed with the disease are still alive. Kaplan-Meier estimates as percentage of patients alive.
- Progression-free Survival (PFS) [ Time Frame: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301391
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|United States, Maryland|
|NIH, Center for Cancer Research, Medical Oncology|
|Bethesda, Maryland, United States, 20892|
|Fondazione IRCCS Istituto Nazionale dei Tumori di Milano|
|Milano, (mi), Italy, 20133|
|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:||Giuseppe Giaccone, MD||MedStar Gergetown University Hospital|