BAL101553 in Patients with Advanced Solid Tumors

Phase 1

• Conditions: Advanced or recurrent solid tumors; MedDRA version: 16.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024237-23-GB
• Lead Sponsor: Basilea Pharmaceutica International Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-04
• Study Completion: 2016-04-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 73

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified