Clinical trial NCT01397929: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Organ Tumors
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553
timeFrame: 28 day cycles
Secondary outcomes:
measure: To evaluate safety and tolerability of BAL101553 treatment
timeFrame: 28 day cycles
measure: To evaluate BAL101553 pharmacokinetics
timeFrame: 28 day cycles
measure: To assess anti-tumor activity of BAL101553
timeFrame: 28 day cycles
measure: To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553
timeFrame: 28 day cycles
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: London
country: United Kingdom
facility: University College London NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
Study officials:
affiliation: Basilea Pharmaceutica International Ltd
name: Marc Engelhardt, MD
role: STUDY_DIRECTOR
References: