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Phase I Study of PDR001 in Patients With Advanced Malignancies.

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.
 
ClinicalTrials.gov Identifier: NCT02678260
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 21, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE February 19, 2016
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
Incidence of dose limiting toxicities (DLTs) [ Time Frame: 28 days ]
cycle = 28 days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • PK parameter: AUC [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) ]
    To characterize the PK profile of PDR001; cycle = 28 days
  • Serum concentration vs. time profiles [ Time Frame: C1D1, C3D1 ]
    Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration
  • Presence and/or concentration of anti-PDR001 antibodies [ Time Frame: Day 1 on from C1 to C6 ]
    To assess the emergence of anti-PDR001 antibodies following one or more intravenous infusions of PDR001.
  • Objective response rate (ORR) [ Time Frame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) ]
    cycle = 28 days
  • Duration of response rate (DOR) [ Time Frame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) ]
    cycle = 28 days
  • Disease control rate (DCR) [ Time Frame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) ]
    cycle = 28 days
  • PK parameter: Cmax [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) ]
    To characterize the PK profile of PDR001; cycle = 28 days
  • PK parameter: Tmax [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) ]
    To characterize the PK profile of PDR001; cycle = 28 days
  • PK parameter: half-life [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) ]
    To characterize the PK profile of PDR001; cycle = 28 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study of PDR001 in Patients With Advanced Malignancies.
Official Title  ICMJE A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
Brief Summary The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Malignancies
Intervention  ICMJE Drug: PDR001
PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1.
Study Arms  ICMJE Experimental: PDR001
PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established.
Intervention: Drug: PDR001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2016)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
  • ECOG Performance Status ≤ 2

Exclusion Criteria:

  • Active autoimmune disease
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Prior PD-1- or PD-L1-directed therapy

Other protocol defined inclusion/exclusion may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678260
Other Study ID Numbers  ICMJE CPDR001X1101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP