Neoplasms

Blood and Lymph Conditions

All Conditions

Thymoma

Thymus Neoplasms

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

All Drugs and Chemicals

Maleic acid

Enzyme Inhibitors

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.

Milciclib Maleate

Arun Rajan, MD.

Marina C. Garassino, MD.

Giuseppe Giaccone, MD

The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.

This is a single-arm, open-label, multicenter, phase II clinical trial design with an early stopping rules. PHA-848125AC will be administered to patients with recurrent metastatic unresectable B3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of the patients. The primary end point for this study is a progression free survival rate of 3 months.

Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

Phase II Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

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.

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.

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.

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.

Calculated in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.

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.

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.

Tiziana Life Sciences LTD

Milciclib Maleate capsules

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.

Milciclib

Age, Categorical

Age, Continuous

Sex: Female, Male

White

Black

Asian

Not Listed

Race/Ethnicity, Customized

United States

Italy

Region of Enrollment

B3 - Well Differentiated Thymic Carcinoma

C - Thymic Carcinoma

World Health Organization classification (International Classification of Diseases)

Tumor extent at study entry

Staging used to evaluate invasiveness of the tumor.

Masaoka clinical staging at study entry

Dr. Davite Cristina

H0:p≤ 25% vs H1:p\> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If \>=4 successes out of the first 15 patients are observed, accrual will continue up to 30.

Success

Failure

Evaluable patients, i.e., consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and \> or = 1 on-treatment tumor/oncologic assessment(s) or die before tumor re-assessment.

Progression-free Survival Rate at 3 Months

N° patients with Adverse Events

N° patients with abnormal Hematology test

N° patients with abnormal Blood chemistry test

Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters

Evaluable population: the patient population consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and \> or = 1 on-treatment tumor/oncologic assessment(s) or die before tumor re-assessment.

Objective Response Rate (ORR)

Disease Control Rate (ORR+SD Rate)

Patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.

Spots Global Cancer Trial Database for Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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