Description:
First in human, open-label, sequential dose escalation and expansion study of intravenous
BAL101553 in adult patients with advanced solid tumors.
Title
- Brief Title: An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors
- Official Title: An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CDI-CS-001
- NCT ID:
NCT01397929
Conditions
Interventions
Drug | Synonyms | Arms |
---|
BAL101553 | | Drug: BAL101553 at 50% of MTD |
Purpose
First in human, open-label, sequential dose escalation and expansion study of intravenous
BAL101553 in adult patients with advanced solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
Drug: BAL101553 at MTD | Experimental | | |
Drug: BAL101553 at 50% of MTD | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years
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:colorectal;
gastric or cancers of the gastro-esophageal junction; non-small cell lung cancer;
ovarian (or primary peritoneal); pancreatic (including ampullary); triple-negative
breast
3. Measurable tumor disease (or non-measurable ovarian cancer that can be followed by
CA-125)
4. Life expectancy ≥ 12 weeks
5. Acceptable organ and marrow function at baseline (protocol defined laboratory
parameters)
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
7. Other protocol-defined inclusion criteria may apply.
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 from side effects of prior therapies
2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active
disease
3. Peripheral neuropathy ≥ CTCAE v4 grade 2
4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or
limit compliance with study requirements
5. Women who are pregnant or breast-feeding. Men or women of reproductive potential who
are not willing to apply effective birth control
6. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed
as part of the screening examination.
7. Patients treated with a calcium channel blocker or who require combination of more
than 2 antihypertensives to control blood pressure.
8. Other protocol-defined exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553 |
Time Frame: | 28 day cycles |
Safety Issue: | |
Description: | First-cycle dose limiting toxicities (DLT) |
Secondary Outcome Measures
Measure: | To evaluate safety and tolerability of BAL101553 treatment |
Time Frame: | 28 day cycles |
Safety Issue: | |
Description: | Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments |
Measure: | To evaluate BAL101553 pharmacokinetics |
Time Frame: | 28 day cycles |
Safety Issue: | |
Description: | BAL101553 and BAL27862 PK parameters including (but not limited to): Cmax (maximum observed plasma concentration), AUC (area under the concentration time curve), half-life, volume of distribution |
Measure: | To assess anti-tumor activity of BAL101553 |
Time Frame: | 28 day cycles |
Safety Issue: | |
Description: | Response rate per RECIST guidelines |
Measure: | To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553 |
Time Frame: | 28 day cycles |
Safety Issue: | |
Description: | Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Basilea Pharmaceutica |
Last Updated
November 13, 2019