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An Open-label Extension Study of PSMA ADC 2301 in mCRPC

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ClinicalTrials.gov Identifier: NCT02020135
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : February 23, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: PSMA ADC

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: PSMA ADC

Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.

PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.


Participant Flow:   Overall Study
    Arm 1: PSMA ADC
STARTED   9 
COMPLETED   0 
NOT COMPLETED   9 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PSMA ADC Chemotherapy-experienced

Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.

PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.

PSMA ADC Chemotherapy-naive

Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.

PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.

Total Total of all reporting groups

Baseline Measures
   PSMA ADC Chemotherapy-experienced   PSMA ADC Chemotherapy-naive   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   3   9 
Age 
[Units: Years]
Mean (Full Range)
 73.2 
 (66 to 81) 
 77.3 
 (70 to 84) 
 74.6 
 (66 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      6 100.0%      3 100.0%      9 100.0% 
Prostate specific antigen (PSA) 
[Units: ug/mL]
Mean (Standard Deviation)
 1446.3  (2209.9)   91.3  (125.8)   994.6  (1874.9) 
PSA 
[Units: ug/mL]
Median (Full Range)
 442.2 
 (107.9 to 5781.1) 
 32.1 
 (6.0 to 235.8) 
 221.2 
 (6.0 to 5781.1) 


  Outcome Measures

1.  Primary:   Percentage of Participants With Total Serum PSA Response   [ Time Frame: 25 Weeks ]

2.  Primary:   CTC Response   [ Time Frame: 25 weeks ]

3.  Primary:   Overall Radiologic Response   [ Time Frame: 25 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Vincent A. DiPippo
Organization: Progenics Pharmaceuticals, Inc.
phone: (646) 975-2502
e-mail: vdipippo@progenics.com



Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02020135     History of Changes
Other Study ID Numbers: PSMA ADC 2301EXT
First Submitted: December 18, 2013
First Posted: December 24, 2013
Results First Submitted: December 28, 2016
Results First Posted: February 23, 2017
Last Update Posted: March 24, 2017