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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397929
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : April 7, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Solid Organ Tumors Drug: BAL101553 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors
Study Start Date : June 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Drug: BAL101553 at MTD Drug: BAL101553
Intravenous administration

Experimental: Drug: BAL101553 at 50% of MTD Drug: BAL101553
Intravenous administration

Primary Outcome Measures :
  1. To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553 [ Time Frame: 28 day cycles ]
    First-cycle dose limiting toxicities (DLT)

Secondary Outcome Measures :
  1. To evaluate safety and tolerability of BAL101553 treatment [ Time Frame: 28 day cycles ]
    Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments

  2. To evaluate BAL101553 pharmacokinetics [ Time Frame: 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

  3. To assess anti-tumor activity of BAL101553 [ Time Frame: 28 day cycles ]
    Response rate per RECIST guidelines

  4. To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553 [ Time Frame: 28 day cycles ]
    Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397929

United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
University College London NHS Foundation Trust
London, United Kingdom, WC1E 2PG
Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Basilea Pharmaceutica

Responsible Party: Basilea Pharmaceutica Identifier: NCT01397929     History of Changes
Other Study ID Numbers: CDI-CS-001
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016