Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.
This study is currently recruiting participants.
Verified May 2013 by Bayer
Information provided by:
First received: September 1, 2011
Last updated: May 10, 2013
Last verified: May 2013
BAY94-9343 is an antibody-drug conjugate directed against the cancer antigen mesothelin. This study will attempt to answer the following questions:
- What are the side effects of the BAY94-9343 when given at different dose levels?
- What dose level of BAY94-9343 should be tested in future clinical research studies?
- How much BAY94-9343 is in the blood at specific times after administration?
- Does the treatment with BAY94-9343 show any effect on the tumor growth?
- Are there specific biomarkers that might be able to explain why some patients respond to treatment and others do not?
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose of the Anti-mesothelin Antibody Drug Conjugate BAY94-9343 in Subjects With Advanced Solid Tumors|
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Determination of maximum tolerated dose [ Time Frame: 2 years / assessment of dose limiting toxicities in Cycle 1 ] [ Designated as safety issue: Yes ]
- Determination of the Pharmakokinetic profile of BAY94-9343 and its metabolites [ Time Frame: 2 years / Cycle 1 Day 1: PK samples at 0, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168, 336, 504 hours after start of infusion; Cycle 3 Day 1: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 48, 96, 168, 336, 504 hours after start of infusion. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Biomarker evaluation: mesothelin tumor levels, soluble mesothelin plasma levels [ Time Frame: 2 years / baseline, Days 1, 2, 3, 5, 15 of Cycle, 1, Days 1 and 15 of all subsequent cycles ] [ Designated as safety issue: No ]
- Tumor response: assessment of best response, TTP (time to progression), and PFS (progression free survival) according to RECIST (Response Evaluation Criteria in Solid Tumours) 1.1 [ Time Frame: 2 years / assessment at baseline, every 6 weeks of for the first 8 cylces, afterwards every 12 weeks ] [ Designated as safety issue: No ]
- Immunogenicity assessment: assessment of anti BAY 94-9343 antibodies [ Time Frame: 2 years / Cycle 1 Day 1 (pre-dose), Cycle 1 Day 8, Cycle 2 Day 1 and Day 1 of every even cycle (4, 6, 8 etc.) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
BAY94-9343 will be administered intravenously in this study. The starting dose for this first-in-man study is 0.15 mg/kg administered as a 1 hour infusion every 21 days.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439152
|Contact: Bayer Clinical Trials Contactfirstname.lastname@example.org|
|Contact: For trial location information (Phone Menu Options '3' or '4')||(+)1-888-84 22937|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Houston, Texas, United States, 77030|
Sponsors and Collaborators
|Study Director:||Bayer Study Director||Bayer|