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

NCT ID: NCT01397929

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-04-30

Brief Summary

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

Conditions

Solid Organ Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug: BAL101553 at MTD

Group Type: EXPERIMENTAL

BAL101553

Intervention Type: DRUG

Intravenous administration

Drug: BAL101553 at 50% of MTD

Group Type: EXPERIMENTAL

BAL101553

Intervention Type: DRUG

Intravenous administration

Interventions

BAL101553

Intravenous administration

Intervention Type: DRUG

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Engelhardt, MD

Role: STUDY_DIRECTOR

Basilea Pharmaceutica International Ltd

Locations

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

University College London NHS Foundation Trust

London, , United Kingdom

Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Other Identifiers

CDI-CS-001

Identifier Type: -

Identifier Source: org_study_id