Clinical trial · Interventional
A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer
A Clinical Phase I / II Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer
NCT01188707CI-TRIAL-00047716terminatedPhase 1 / Phase 2ClinicalTrials.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): Dose over MTD reached
Summary
Brief summary (as posted)
The Belinostat-Erlotinib trial is designed as an open, non randomized phase I / II trial to assess the efficacy and safety of Belinostat in combination with Erlotinib in patients with non-small cell lung cancer who are eligible for treatment with erlotinib.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belinostat and Erlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Belinostat, Erlotinib, NSCLC
- interventionNames
- Drug: Belinostat and Erlotinib
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 1 year
- description
- The primary purpose of the phase I part of the trial is to establish the tolerance dose (maximum tolerated dose (MTD) and dose limiting toxicity (DLT).
Secondary outcomes (1)
- measure
- Efficacy
- timeFrame
- 1 year
- description
- The phase II part of the study is to assess the efficacy of Belinostat and Erlotinib in combination assessed by disease control rate, defined as non - progression at 3 months / Stable disease or better) using RECIST response criteria version 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed consent of an approved informed consent form 2. A. For the dose escalation phase: Patients with histological or cytological confirmed non-small cell lung cancer who are rated suitable for treatment with Erlotinib B. For MTD expansion phase: Patients diagnosed with non- small cell lung cancer rated suitable for treatment with Erlotinib and with measurable disease according to RECIST version 1.1 3. Performance status (ECOG) ≤ 2 4. Life expectancy at least 3 months 5. Age ≥ 18 years 6. Acceptable liver, kidney and bone marrow function, defined as: * Bilirubin ≤ 1.5 x upper limit of normal (ULN) * ASAT, ALAT and alkaline phosphatase ≤ 3 x ULN (if liver metastases is ≤ 5 x ULN allowed) * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) * WBC\> 2.5 x 109 / l, neutrophils\> 1.0 x 109 / l, platelets\> 100 x 109 / l * Hemoglobin\> 9.0 g / dl or\> 5.6 mmol / l 7. Acceptable coagulation: PT and APTT within ≤ 1.5 x ULN or in the therapeutic range if given anticoagulant 8. A negative pregnancy test for women of childbearing age. In fertile men and women the use of effective contraception methods are required during the trial 9. Serum potassium within normal range Exclusion Criteria: 1. Treatment with experimental drugs within the last 4 weeks 2. Former anti-cancer therapy within the last 3 weeks before the start of experimental treatment, including chemotherapy, radiotherapy, endocrine therapy or immunotherapy 3. Simultaneous presence of active infection or other concomitant present medical condition likely to affect the experimental procedures, including significant cardiovascular disease (New York Heart Association Class III or IV heart disease, myocardial infarction within the past 6 months, unstable angina, congestive heart failure requiring treatment, unstable arrhythmia or the need for antiarrhythmic drugs or signs of ischemia on ECG, marked baseline prolongation of QT / QTc interval, for example repeated demonstration of a QTc interval\> 500 msec; long QT syndrome; required the use of concurrent medication on dosage belinostat days, which may cause torsades de pointes (see Appendix 1). 4. Altered mental status that prevents understanding of the informed consent process and / or execution of the necessary experiments 5. Secondary malignancy present (previous malignancy accepted if cured by treatment for \> 3 years ago) 6. Intestinal obstruction or threatening bowel obstruction
References
Publications (0)
Data not yet available
No reference posted for this study.