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Trial record 1 of 1 for:    medi3726
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A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer (MEDI3726)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02991911
First received: December 1, 2016
Last updated: July 12, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to assess the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726 in subjects with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.

Condition Intervention Phase
Metastatic Castration Resistant Prostate Cancer Biological: MEDI3726 Post-Chemo Biological: MEDI3726 Pre-Chemo Biological: MEDI3726 & Enzalutamide Combo Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI3726 in Subjects With Metastatic Castration Resistant Prostate Cancer Who Have Received Prior Treatment With Abiraterone or Enzalutamide

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Occurrence of adverse events (AEs) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
    Safety Endpoint

  • Occurrence of serious adverse events (SAEs) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
    Safety Endpoint

  • Occurrence of dose-limiting toxicities (DLTs) [ Time Frame: From time of informed consent through 21 days after first dose of MEDI3726 ]
    Safety Endpoint

  • Number of patients with changes in laboratory parameters from baseline [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
    Safety Endpoint

  • Number of patients with changes in vital signs from baseline [ Time Frame: From time of informed consent through 21 days after last dose of MEDI3726 ]
    Safety Endpoint

  • Number of patients with changes in electrocardiogram (ECG) results from baseline [ Time Frame: From time of informed consent through 21 days after last dose of MEDI3726 ]
    Safety Endpoint


Secondary Outcome Measures:
  • Response Evaluation Criteria in Solid Tumors (RECIST) response [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
    Response according to RECIST version 1.1

  • PSA50 response [ Time Frame: From time of informed consent through at least 12 weeks after last dose of MEDI3726 ]
    Reduction in PSA level of 50% (PSA50) or more compared with baseline

  • Circulating Tumor Cell (CTC) response [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
    Conversion in the CTC count defined as a reduction from ≥ 5 cells/7.5 mL blood to < 5 cells/7.5 mL blood

  • Safety and tolerability of MEDI3726 in combination with Enzalutamide [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 with enzalutamide ]
    Measured by occurrence of AEs, SAEs, DLTs and number of patients with changes in laboratory parameters, vital signs, and ECG results from baseline

  • MEDI3726 plasma concentrations for pharmacokinetics (PK) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
  • MEDI3726 maximum observed concentration for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
  • MEDI3726 area under the concentration-time curve for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
  • MEDI3726 clearance for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
  • MEDI3726 terminal half-life for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
  • Number and percentage of subjects who develop anti-drug antibodies (ADAs) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
    To determine the immunogenicity of MEDI3726


Estimated Enrollment: 224
Actual Study Start Date: January 6, 2017
Estimated Study Completion Date: July 29, 2021
Estimated Primary Completion Date: July 29, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
MEDI3726 Post-Chemo
Biological: MEDI3726 Post-Chemo
Single agent MEDI3726 after abiraterone or enzalutatmide, with a prior taxane-based chemotherapy in the mCRPC setting
Experimental: Arm B
MEDI3726 Pre-Chemo
Biological: MEDI3726 Pre-Chemo
Single agent MEDI3726 after abiraterone or enzalutatmide, without a prior taxane-based chemotherapy in the mCRPC setting
Experimental: Arm C
MEDI3726 & Enzalutamide Combo
Biological: MEDI3726 & Enzalutamide Combo
MEDI3726 in combination with Enzalutatmide after prior treatment with abiraterone, with or without a prior taxane-based chemotherapy in the mCRPC setting

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years at the time of screening.
  • Histologically confirmed diagnosis of metastatic castration-resistant prostate adenocarcinoma (mCRPC).
  • Documented PD in subjects with mCRPC as assessed by the Investigator and defined by at least one of the following according to the PCWG3 criteria:

    1. Radiographic progression.
    2. PSA progression.
  • Prior exposure to abiraterone or enzalutamide of at least 12 weeks in the mCRPC setting.

NOTE: Subjects who have received both abiraterone and enzalutamide in the mCRPC setting are eligible.

  • In dose escalation: Prior taxane-based chemotherapy in the mCRPC setting is:

    1. Required for Arm A.
    2. Excluded for Arm B.
    3. Optional for Arm C.

      Exclusion Criteria:

  • Subjects with neuroendocrine, neuroendocrine differentiation and/or small cell prostate cancer.
  • The subject has received any conventional or investigational anti-cancer treatment within 21 days before the first dose of investigational product, with the following modifications:

    1. At least 14 days before the first dose of investigational product since completion of treatment with abiraterone or enzalutamide
    2. At least 14 days before the first dose of investigational product since completion of prior taxane-based chemotherapy
    3. At least 28 days before the first dose of investigational product since completion of treatment with Radium-223.
    4. At least 42 days before the first dose of investigational product since completion of prior bicalutamide and nilutamide treatment.

NOTE: An LHRH agonist or antagonist required for ongoing testosterone suppression will be permitted if Inclusion Criterion is satisfied.

  • Prior exposure to PSMA-directed therapies.
  • Subjects with previous radiotherapy for the treatment of unresectable, locally advanced or metastatic prostate cancer are excluded if:

    1. More than 25% of marrow-bearing bone has been irradiated.
    2. The last fraction of radiotherapy has been administered within approximately 2 weeks prior to the first dose of investigational product.
  • Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to the first dose of investigational product.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02991911

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locater Service 1-877-400-4656 AstraZeneca@emergingmed.com

Locations
United States, Connecticut
Research Site Recruiting
New Haven, Connecticut, United States, 06519
United States, Florida
Research Site Recruiting
Sarasota, Florida, United States, 34232
United States, Virginia
Research Site Recruiting
Norfolk, Virginia, United States, 23502
Switzerland
Research Site Recruiting
Chur, Switzerland, 7000
United Kingdom
Research Site Recruiting
London, United Kingdom, SM2 5PT
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: MedImmune LLC Sponsor GmbH
  More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02991911     History of Changes
Other Study ID Numbers: D9320C00001
Study First Received: December 1, 2016
Last Updated: July 12, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MedImmune LLC:
metastatic, prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 17, 2017