Advanced or recurrent solid tumors MedDRA version: 16.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: BAL101553
Product Code: BAL101553-002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: not assigned yet
Sponsors
Basilea Pharmaceutica International Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available a. Colorectal cancer b.Gastric cancer or cancers of the gastro-oesophageal junction c.Non-small cell lung cancer d. Ovarian (or primary peritoneal) cancer e. Pancreatic cancer (including ampullary cancer) f. Triple-negative breast cancer 3.Patients with known brain metastases must have stable disease for at least 3 months prior to starting study drug. For these patients imaging of the brain is required during the 14-day screening period; patients must have undergone definitive local therapy (resection and/or radiation). Measurable disease (according to RECIST criteria v1.1 or RANO criteria for high-grade glioma) or non-measurable prostate or ovarian cancer that can be followed by PSA or CA-125 4. Life expectancy = 12 weeks 5. Acceptable organ and marrow function 6. ECOG performance status = 2 7. Signed, written informed consent must be obtained and documented according to ICH-GCP 8. Other protocol-defined inclusion criteria apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered to = CTCAE v4 grade 1 from all side effects of prior therapies except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk 2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease 3. Peripheral neuropathy = CTCAE v4 grade 2 Known human immunodeficiency virus (HIV) infection 4. Significant cardiac disease or abnormality 5. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements in the opinion of the investigator; including but not limited to: ongoing or active symptomatic infection, uncontrolled diabetes mellitus, unstable or uncompensated cardiac, hepatic, renal, respiratory, or psychiatric illness 6. Current treatment with warfarin potassium or other coumarin derivates. 7. Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control during the study and for at least 30 days after the last dose of study drug in both sexes 8. Other protocol-defined exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The MTD is determined by DLT assessment. A DLT can occur on any dosing day or at any time thereafter. ;Main Objective: The primary objective of this study is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLT) of BAL101553 administered intravenously as single agent on days 1, 8 and 15 of an every 28 day treatment cycle in adults with advanced or recurrent solid tumors, who have failed standard therapy or for whom no effective standard therapy is available; Secondary Objective: Secondary objectives are: •To evaluate the safety and tolerability of BAL101553. •To evaluate BAL101553 and BAL27862 pharmacokinetics. •To assess the anti-tumor activity of BAL101553 in cancer patients. Exploratory objectives are to assess the use of biomarkers and functional imaging to characterize pharmacodynamic effects and to explore the potential utility of biomarkers in blood and/or tumor tissue for patient stratification; and to assess SNP analysis related to drug-metabolism of BAL101553/BAL27862. ;Primary end point(s): The primary objective of this study is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLT) of BAL101553 administered intravenously as single agent on days 1, 8 and 15 of an every 28 day treatment cycle in adults with advanced or recurrent solid tumors, who have failed standard therapy or for whom no effective standard therapy is available. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability, pharmacokinetics, anti-tumor activity; Timepoint(s) of evaluation of this end point: Safety and tolerability is assessed during the whole clinical trial. Pharmacokinetic is assessed at prespecified time points at day 1, day 8 and day 15 during cycle 1 and cylce 2. | — |
Countries
United Kingdom
Contacts
Public ContactMedical Information
Basilea Pharmaceutical International Ltd.
Outcome results
None listed