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.

Duration of Response

Overall Survival

Progression-free Survival (PFS)

Overall Study

Carcinoma

Neoplasms, Glandular and Epithelial

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

Glen Weiss, MD

Benjamin Besse, MD

Julien Mazières, MD

Silvia Novello, MD

Marina C Garassino, MD

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.

Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma

Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With 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

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\>/= 6 weeks). The analysis was performed in the evaluable populations.

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

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.

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.

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.

Milciclib Maleate (PHA-848125AC)

Not allowed to ask per local regulation

Missing

France

B3 - Well differantiated thymic carcinoma

WHO - Classification

Locally advanced

Metastatic

Stage I: grossly and microscopically encapsulated

Stage II: thymoma invades beyond the capsule

Stage III: macroscopic invasion neighboring organs

Stage IV A: pleural or pericardial dissemination

Stage IVB:hematogeneous or lymphatic dissemination

Dr. Cristina Davite

H0:p\</=17% vs. H1:p\>17%, with an interesting PFS-3 rate of 33% or higher; Power=80%; Alpha(1-sided)=5%, 54 evaluable patients are required for a Simon optimal two stage design trial. If at least 4 successes among the first 17 evaluable patients are observed in the 1st stage, patients' enrollment proceed up to the final analysis where at least 14/54 successes (PFS-3 rate ≥ 25.9%) must be required to reject the null hypothesis.

Evaluable patients: population consisting of all treated patients who fulfill the following conditions:

* histological confirmation of thymic carcinoma by an Independent Review Committee
* received at least 80% of drug in the first two cycles overall
* baseline and \>/= 1 on treatment tumor assessment or die before tumor re-assessment

Confirmed Objective Response Rate (ORR)

Disease Control Rate

Progression-free Survival

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy	NCT01301391	Malignant Thymo...	Milciclib Malea...	18 Years -	Tiziana Life Sciences LTD
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma	NCT01011439	Thymic Carcinom...	Milciclib Malea...	18 Years -	Tiziana Life Sciences LTD
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma	NCT01011439	Thymic Carcinom...	Milciclib Malea...	18 Years -	Tiziana Life Sciences LTD
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma	NCT01011439	Thymic Carcinom...	Milciclib Malea...	18 Years -	Tiziana Life Sciences LTD

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