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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Basilea Pharmaceutica
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01397929
First received: July 12, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Solid Organ Tumors
Drug: BAL101553
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
    First-cycle dose limiting toxicities (DLT)


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

  • To evaluate BAL101553 pharmacokinetics [ Time Frame: 28 day cycles ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 day cycles ] [ Designated as safety issue: No ]
    Response rate per RECIST guidelines

  • To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553 [ Time Frame: 28 day cycles ] [ Designated as safety issue: No ]
    Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers


Estimated Enrollment: 64
Study Start Date: June 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: BAL101553 at MTD Drug: BAL101553
Intravenous administration
Experimental: Drug: BAL101553 at 50% of MTD Drug: BAL101553
Intravenous administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397929

Contacts
Contact: Marc Engelhardt, MD +41 61 567 1546 marc.engelhardt@basilea.com
Contact: Stephanie Anderson +41 61 567 15 24 stephanie.anderson@basilea.com

Locations
United Kingdom
Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Rhoda Molife, MD    +44 (0) 208 915 6142    Rhoda.Molife@icr.ac.uk   
Principal Investigator: Rhoda Molife, MD         
University College London NHS Foundation Trust Recruiting
London, United Kingdom, WC1E 2PG
Contact: Rebecca Kristeleit, MD    +44 (0) 2076799279    r.kristeleit@ucl.ac.uk   
Principal Investigator: Rebecca Kristeleit, MD         
Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Contact: Ruth Plummer, MD    +44 191 213 8453    ruth.plummer@newcastle.ac.uk   
Principal Investigator: Ruth Plummer, MD         
Sponsors and Collaborators
Basilea Pharmaceutica
  More Information

No publications provided

Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT01397929     History of Changes
Other Study ID Numbers: CDI-CS-001
Study First Received: July 12, 2011
Last Updated: June 13, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 19, 2014