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

NCT01397929 | Completed Phase 1

• 1 other identifier: CDI-CS-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553

  First-cycle dose limiting toxicities (DLT)

  28 day cycles

Secondary Outcomes (4)

• To evaluate safety and tolerability of BAL101553 treatment

  28 day cycles

• To evaluate BAL101553 pharmacokinetics

  28 day cycles

• To assess anti-tumor activity of BAL101553

  28 day cycles

• To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553

  28 day cycles

Study Arms (2)

Drug: BAL101553 at MTD

EXPERIMENTAL

Drug: BAL101553

Drug: BAL101553 at 50% of MTD

EXPERIMENTAL

Drug: BAL101553

Interventions

BAL101553 DRUG

Intravenous administration

Drug: BAL101553 at 50% of MTD; Drug: BAL101553 at MTD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

Study Sites (3)

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

University College London NHS Foundation Trust

London, WC1E 2PG, United Kingdom

Location

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

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Interventions

lisavanbulin

Study Officials

• Marc Engelhardt, MD

  Basilea Pharmaceutica International Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 20, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

GB (3)