Clinical trial · Interventional
Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy
Phase II Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy
NCT01301391CI-TRIAL-00036959terminatedPhase 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 last patient 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 in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of 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 |
|---|---|---|---|
| Malignant Thymoma | Malignant Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Milciclib Maleate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Milciclib
- description
- Milciclib Maleate capsules
- 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
- Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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 (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
References
Publications (0)
Data not yet available
No reference posted for this study.