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

NCT01011439 | Terminated Phase 2 Results

• 2 other identifiers: CDKO-125a-0062009-014338-79
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 6

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.

Conditions

Thymic Carcinoma

Keywords

B3 and C malignant thymoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate at 3 Months

  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

  3 months since treatment start

Secondary Outcomes (6)

• Confirmed Objective Response Rate (ORR)

  Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.

• Disease Control Rate

  Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.

• Progression-free Survival

  Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.

• Duration of Response

  Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.

• Overall Survival

  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.

Study Arms (1)

Milciclib Maleate (PHA-848125AC)

EXPERIMENTAL

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

Interventions

Milciclib Maleate DRUG

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.

Also known as: PHA-848125AC

Milciclib Maleate (PHA-848125AC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tiziana Life Sciences LTD: lead

Study Sites (6)

TGen Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

NIH, Center for Cancer Research, Medical Oncology

Bethesda, Maryland, 20892, United States

Location

Hopital Larrey

Toulouse, 31059, France

Location

Institut de cancerologie Gustave Roussy

Villejuif, 94805, France

Location

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, (MI), 20133, Italy

Location

Azienda Ospedaliera San Luigi Gonzaga

Orbassano, 10043, Italy

Location

MeSH Terms

Conditions

Thymoma

Interventions

N,1,4,4-tetramethyl-8-((4-(4-methylpiperazin-1-yl)phenyl)amino)-4,5-dihydro-1H-pyrazolo(4,3-h)quinazoline-3-carboxamide

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Cristina Davite
• Organization: CLIOSS S.r.l.

regulatory@clioss.com

+39 0031 58

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: February 22, 2010
• Primary Completion: May 31, 2017
• Study Completion: December 17, 2018
• Last Updated: February 6, 2019
• Results First Posted: October 16, 2018

Record last verified: 2019-01

Locations

FR (2); IT (2); US (2)