Condition
Advanced or Metastatic Solid Tumors
Estimated Enrollment: 180
Age Group: 18 Years to 99 Years (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: M16-074|2016-004205-14
Study First Received: March 2, 2017
Last Updated: March 30, 2017
Estimated Primary Completion Date: February 2019
Primary Outcome Measures:
Maximum tolerated dose (MTD) of ABBV-368 when administered as monotherapy or in combination with nivolumab|Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with nivolumab|Maximum observed serum concentration (Cmax) of ABBV-368|Time to Cmax (Tmax) of ABBV-368|Area under the serum concentration-time curve (AUC) of ABBV-368|Terminal phase elimination rate constant (β) of ABBV-368|Terminal half-life (t1/2) of ABBV-368|Number of Participants With Adverse Events|Objective Response Rate (ORR)|Clinical benefit rate (CBR)|Progression-Free Survival (PFS)|Duration of Objective Response (DOR)
Sponsors and Collaborators:
AbbVie
Website Link: https://ClinicalTrials.gov/show/NCT03071757
