Phase 2
Completed N=89
Open, Randomized Phase II Trial to Investigate the Efficacy and Safety of the PLK-1 Inhibitor BI 2536 in Patients With Advanced, Unresectable Pancreatic Cancer
Source: ClinicalTrials.gov NCT00710710 ↗Enrolled (actual)
89
Serious AEs
52.3%
Results posted
May 2022
Primary outcomePrimary: Best Objective Response Evaluated According to the RECIST Criteria by Independent Review — 0; 0; 1; 1 Participants — p=0.7021
Summary
The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Objective Response Evaluated According to the RECIST Criteria by Independent Review |
0; 0; 1; 1; 11; 10 | 0.7021 |
| SECONDARY Tumour Control After the Fourth Treatment Course |
7; 4; 14; 19; 22; 20 | — |
| SECONDARY Duration of Overall Response |
42; 141 | — |
| SECONDARY Progression Free Survival (PFS) |
47; 46 | 0.38 |
| SECONDARY Overall Survival (OS) |
154; 148 | 0.69 |
| SECONDARY Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment |
0; 0; 0; 0; 11; 11 | 0.9161 |
| SECONDARY One-year Survival |
4; 5 | — |
| SECONDARY Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response |
41; 41; 2; 2; 43; 43 | — |
| SECONDARY Number of Participants With Dose Limiting Toxicity (DLT) |
32; 27; 11; 15 | — |
| SECONDARY Quality of Life Assessment, Including Clinical Benefit Response: Overall Health |
3.8; 4.1 | — |
| SECONDARY Quality of Life Assessment, Including Clinical Benefit Response: Quality of Life |
3.8; 4.2 | — |
| SECONDARY Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) |
5; 5; 7; 4; 12; 16 | — |
Eligibility Criteria
Inclusion Criteria
- male or female patient aged 18 years or older
- patient with confirmed diagnosis of unresectable, either locally advanced or metastatic, ductal adenocarcinoma of the pancreas
- patient who is either chemonaïve (for the first line cohorts), or who presents with progressive disease under first line chemotherapy with a gemcitabine based regimen (for the second line cohort)
- Karnofsky performance status of ¿ 70% for the first line cohorts, and Karnofsky performance status ¿ 50% for the second line cohort
- patient with at least one measurable tumour lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension (longest diameter to be recorded)
- life expectancy of at least three months
- patient must have given written informed consent consistent with the guidelines of the international conference on harmonisation for good clinical practice (ICH-GCP) as well as with local legislation
Exclusion Criteria
- prior adjuvant chemotherapy (for first line cohorts only)
- ampullary carcinoma of the pancreas
- hypersensitivity to the trial drug or the excipients
- persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant
- known second malignancy requiring therapy
- brain metastases which are symptomatic or require therapy
- absolute neutrophil count less than 1.500/mm3
- platelet count less than 100.000/mm3
- haemoglobin less than 9 mg/dl
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver metastases
- bilirubin greater than 3.0 mg/dl (> 52 ¿mol/l, SI unit equivalent) under adequate drainaging measures (in case of obstructive jaundice)
- serum creatinine greater than 2.0 mg/dl
- concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
- radiotherapy within the past four weeks prior to treatment with the trial drug
- hormone- or immunotherapy or therapy with a biologic response modifier within the past four weeks
- treatment with any other investigational drug within the past four weeks
- men or women who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. abstinence, condom with spermicidal coating, diaphragm with spermicidal coating, oral contraceptive, progesterone implant, sterilisation) during the trial
- pregnancy or lactation
- patients unable to comply with the protocol
Data sourced from ClinicalTrials.gov (NCT00710710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.