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

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ClinicalTrials.gov Identifier: NCT01011439
Recruitment Status : Active, not recruiting
First Posted : November 11, 2009
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Tiziana Life Sciences, PLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thymic Carcinoma Drug: Milciclib Maleate Phase 2

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
Actual Study Start Date : February 22, 2010
Actual Primary Completion Date : May 31, 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) [ Time Frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. ]
    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.

  2. Disease Control Rate [ Time Frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. ]
    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.

  3. Progression-free Survival [ Time Frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. ]
    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.

  4. Duration of Response [ Time Frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. ]
    Assessed in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.

  5. 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 the start of treatment for a disease, such as cancer, to the date in which the patients diagnosed with the disease were still alive.

  6. Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) [ 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. ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)
  • Presence of measurable disease
  • Age >=18 years
  • ECOG performance status 0-1
  • Negative pregnancy test (if female in reproductive years)
  • Use of effective contraceptive methods if men and women of child producing potential
  • Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed)
  • Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min.
  • Adequate hematologic status ANC >=1,500cells/mm3 Platelet Count >=100,000cells/mm3 Hemoglobin >=9.0g/dL
  • Two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated)
  • Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1

Exclusion Criteria:

  • Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
  • Grade >1 retinopathy
  • Known brain metastases
  • Known active infections
  • Pregnant or breast feeding women
  • Diabetes mellitus uncontrolled
  • Gastrointestinal disease that would impact on drug absorption
  • Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline
  • Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study

Information from the National Library of Medicine

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): NCT01011439


Locations
United States, Arizona
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Maryland
NIH, Center for Cancer Research, Medical Oncology
Bethesda, Maryland, United States, 20892
France
Hopital Larrey
Toulouse Cedex, France, 31059
Institut de cancerologie Gustave Roussy
Villejuif Cedex, France, 94805
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milano, (mi), Italy, 20133
Azienda Ospedaliera San Luigi Gonzaga
Orbassano, Italy, 10043
Sponsors and Collaborators
Tiziana Life Sciences, PLC
Investigators
Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Tiziana Life Sciences, PLC:
Study Protocol  [PDF] March 9, 2017


Responsible Party: Tiziana Life Sciences, PLC
ClinicalTrials.gov Identifier: NCT01011439     History of Changes
Other Study ID Numbers: CDKO-125a-006
2009-014338-79 ( EudraCT Number )
First Posted: November 11, 2009    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by Tiziana Life Sciences, PLC:
B3 and C malignant thymoma

Additional relevant MeSH terms:
Carcinoma
Thymoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action