Status:
COMPLETED
An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Solid Organ Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- 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
- Measurable tumor disease (or non-measurable ovarian cancer that can be followed by CA-125)
- Life expectancy ≥ 12 weeks
- Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Other protocol-defined inclusion criteria may apply.
Exclusion
- 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
- Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
- Peripheral neuropathy ≥ CTCAE v4 grade 2
- Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
- Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control
- Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed as part of the screening examination.
- Patients treated with a calcium channel blocker or who require combination of more than 2 antihypertensives to control blood pressure.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01397929
Start Date
June 1 2011
End Date
April 1 2016
Last Update
May 10 2023
Active Locations (3)
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1
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
2
University College London NHS Foundation Trust
London, United Kingdom, WC1E 2PG
3
Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom, NE7 7DN