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A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

Estimated reading time: 1 min

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

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT03071757

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