An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors

Phase 1

Completed

• Conditions: Solid Organ Tumors
• Interventions: Drug: BAL101553

• Registration Number: NCT01397929
• Lead Sponsor: Basilea Pharmaceutica

Brief Summary

First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: BAL101553 at MTD	BAL101553	-
Drug: BAL101553 at 50% of MTD	BAL101553	-

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553	28 day cycles	First-cycle dose limiting toxicities (DLT)

Secondary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of BAL101553 treatment	28 day cycles	Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments
To evaluate BAL101553 pharmacokinetics	28 day cycles	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
To assess anti-tumor activity of BAL101553	28 day cycles	Response rate per RECIST guidelines
To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553	28 day cycles	Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers

Trial Locations

Locations (3)

Royal Marsden Hospital; 🇬🇧 Sutton, Surrey, United Kingdom

Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care; 🇬🇧 Newcastle upon Tyne, United Kingdom

University College London NHS Foundation Trust; 🇬🇧 London, United Kingdom