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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 )

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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: PDR001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
Actual Study Start Date : February 19, 2016
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs) [ Time Frame: 28 days ]
    cycle = 28 days


Secondary Outcome Measures :
  1. 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

  2. Serum concentration vs. time profiles [ Time Frame: C1D1, C3D1 ]
    Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678260


Locations
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Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 466-8560
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02678260    
Other Study ID Numbers: CPDR001X1101
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced malignancies
PDR001
Japanese patients
adults
Additional relevant MeSH terms:
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Neoplasms