Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
Tiziana Life Sciences, PLC
ClinicalTrials.gov Identifier:
NCT01011439
First Posted: November 11, 2009
Last Update Posted: July 18, 2017
Information provided by (Responsible Party):
Tiziana Life Sciences, PLC
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Thymic Carcinoma | Drug: Milciclib Maleate | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Further study details as provided by Tiziana Life Sciences, PLC:
Primary Outcome Measures:
- Progression-free survival rate at 3 months [ Time Frame: 3 months since treatment start ]
Secondary Outcome Measures:
- Overall safety profile [ Time Frame: All cycles from enrollment to 28 days after last treatment ]
- Assessment of additional measures of tumor control to further characterize the efficacy profile of PHA-848125AC [ Time Frame: Every 6 weeks during the entire study ]
- Explorative baseline characterization of biomarkers in tumor tissue of consenting patients [ Time Frame: Baseline ]
| Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicentre 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.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and Locations
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
| Study Director: | Anna Petroccione, MD | CLIOSS (Nerviano Medical Sciences Group), Italy |
| 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 |
More Information
| 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 Submitted: | November 10, 2009 |
| First Posted: | November 11, 2009 |
| Last Update Posted: | July 18, 2017 |
| Last Verified: | July 2017 |
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 |