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

NCT01301391 | Terminated Phase 2 Results

• 1 other identifier: CDKO-125a-007
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Malignant Thymoma

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)

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

  Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 two-week cycles.

• Objective Response Rate (ORR)

  Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

• Disease Control Rate (ORR+SD Rate)

  Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

• Duration of Response

  Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

• 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

EXPERIMENTAL

Milciclib Maleate capsules

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

Eligibility Criteria

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

You may qualify if:

• Signed and dated IRB/Approved Informed Consent
• Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease
• Presence of measurable disease
• Age \>=18 years old
• 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 (with the exception of myasthenia gravis), 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 (3)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

NIH, Center for Cancer Research, Medical Oncology

Bethesda, Maryland, 20892, United States

Location

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, (mi), 20133, 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. Davite Cristina
• Organization: CLIOSS S.r.l.

regulatory@clioss.com

+39 0031 58

Study Officials

• Arun Rajan, MD.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

• Marina C. Garassino, MD.

  Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

  PRINCIPAL INVESTIGATOR

• Giuseppe Giaccone, MD

  MedStar Gergetown University Hospital

  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: February 15, 2011
• First Posted: February 23, 2011
• Study Start: February 2, 2011
• Primary Completion: May 31, 2017
• Study Completion: December 17, 2018
• Last Updated: February 6, 2019
• Results First Posted: October 4, 2018

Record last verified: 2019-01

Locations

IT (1); US (2)