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A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT01695044
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : February 23, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Brief Summary:
PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: PSMA ADC Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer
Study Start Date : September 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm 1: PSMA ADC
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
Drug: PSMA ADC
PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.




Primary Outcome Measures :
  1. Percentage of Participants With Total Serum PSA Response [ Time Frame: 24 Weeks ]
    Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.

  2. CTC Response [ Time Frame: 24 Weeks ]
    Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.

  3. Overall Radiologic Response [ Time Frame: 24 weeks ]
    Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.



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

Inclusion Criteria:

  1. A diagnosis of metastatic castration-resistant prostate cancer.
  2. a) Prior history of treatment with at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation.

    OR

    b) No prior history of treatment with a cytotoxic chemotherapy regimen.

  3. Must have received and progressed on abiraterone acetate and/or enzalutamide. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  5. Life expectancy ≥ six months.
  6. Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.

Exclusion Criteria:

  1. Treatment within 30 days prior to first dose of study drug of the following:

    • External Radiation therapy
    • Radiopharmaceuticals
    • Cytotoxic chemotherapy
    • Treatment with an investigational agent
  2. Clinically significant cardiac disease or severe debilitating pulmonary disease
  3. An acute infection requiring ongoing antibiotic therapy
  4. Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor.
  5. History of drug and/or alcohol abuse
  6. History of pancreatitis

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): NCT01695044


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35205
United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
Burbank, California, United States, 91505
Encinitas, California, United States, 92024
Los Angeles, California, United States, 90024
San Diego, California, United States, 92123
United States, Colorado
Denver, Colorado, United States, 80218
United States, Connecticut
New Haven, Connecticut, United States, 06520
Norwalk, Connecticut, United States, 06856
United States, Florida
Port St. Lucie, Florida, United States, 34952
United States, Hawaii
Honolulu, Hawaii, United States, 96819
United States, Kansas
Fairway, Kansas, United States, 66205
United States, Louisiana
New Orleans, Louisiana, United States, 70115
United States, Maryland
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21205
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Ann Arbor, Michigan, United States, 28109
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Nebraska
Omaha, Nebraska, United States, 68130
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
Lake Success, New York, United States, 11042
New York, New York, United States, 10065
Rochester, New York, United States, 14642
Stony Brook, New York, United States, 11794
United States, North Carolina
Huntersville, North Carolina, United States, 28078
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, South Carolina
Greenville, South Carolina, United States, 29605
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Memphis, Tennessee, United States, 38120
United States, Texas
Dallas, Texas, United States, 75390
United States, Virginia
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
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Study Director: Vivien Wong, PhD Progenics Pharmaceuticals, Inc.
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Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01695044    
Other Study ID Numbers: PSMA ADC 2301
First Posted: September 27, 2012    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: March 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases