Clinical Trials /

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

NCT01397929

Description:

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

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CDI-CS-001
  • NCT ID: NCT01397929

Conditions

  • Solid Organ Tumors

Interventions

DrugSynonymsArms
BAL101553Drug: BAL101553 at MTD

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Drug: BAL101553 at MTDExperimental
  • BAL101553
Drug: BAL101553 at 50% of MTDExperimental
  • BAL101553

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553
Time Frame:28 day cycles
Safety Issue:
Description:First-cycle dose limiting toxicities (DLT)

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Basilea Pharmaceutica

Last Updated

April 6, 2016