Clinical trial · Interventional
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
NCT01011439CI-TRIAL-00036971terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): For the 2 last patients still on treated nominal therapeutic use of the Milciclib was approved at INT Milano.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Milciclib Maleate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Milciclib Maleate (PHA-848125AC)
- description
- 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
- interventionNames
- Drug: Milciclib Maleate
Primary outcomes (1)
- measure
- Progression-free Survival Rate at 3 Months
- timeFrame
- 3 months since treatment start
- description
- 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 outcomes (6)
- measure
- Confirmed Objective Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.