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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
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: PSMA ADC
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 9
Completed 0
Not Completed 9
Arm/Group Title PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive Total
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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.

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 of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants
73.2
(66 to 81)
77.3
(70 to 84)
74.6
(66 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 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)  
Mean (Standard Deviation)
Unit of measure:  ug/mL
Number Analyzed 6 participants 3 participants 9 participants
1446.3  (2209.9) 91.3  (125.8) 994.6  (1874.9)
PSA  
Median (Full Range)
Unit of measure:  ug/mL
Number Analyzed 6 participants 3 participants 9 participants
442.2
(107.9 to 5781.1)
32.1
(6.0 to 235.8)
221.2
(6.0 to 5781.1)
1.Primary Outcome
Title Percentage of Participants With Total Serum PSA Response
Hide Description Total serum PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.
Time Frame 25 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.
Arm/Group Title PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive
Hide Arm/Group Description:

The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).

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.

The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.

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.

Overall Number of Participants Analyzed 6 3
Measure Type: Number
Unit of Measure: % of responders
>30% Decrease in PSA 67 33
>50% Decrease in PSA 33 0
2.Primary Outcome
Title CTC Response
Hide Description Circulating tumor cells (CTC) response was measured at baseline and had at least one post-baseline assessment. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 50%.
Time Frame 25 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.
Arm/Group Title PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive
Hide Arm/Group Description:

The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).

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.

The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.

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.

Overall Number of Participants Analyzed 5 2
Measure Type: Number
Unit of Measure: % of responders
100 50
3.Primary Outcome
Title Overall Radiologic Response
Hide Description Overall radiologic response was measured at baseline and post-baseline. 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.
Time Frame 25 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). All subjects (n=9) enrolled in 2301EXT were evaluated.
Arm/Group Title PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive
Hide Arm/Group Description:

The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).

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.

The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.

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.

Overall Number of Participants Analyzed 6 3
Measure Type: Number
Unit of Measure: % of subjects
Partial response 17 0
Stable disease 83 100
Time Frame 25 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive
Hide Arm/Group Description

The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).

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.

The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.

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.

All-Cause Mortality
PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   0/3 (0.00%) 
Cardiac disorders     
Tachycardia  1  1/6 (16.67%)  0/3 (0.00%) 
Infections and infestations     
Pneumonia  1  1/6 (16.67%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA®, Version 15
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
PSMA ADC Chemotherapy-experienced PSMA ADC Chemotherapy-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  1/6 (16.67%)  0/3 (0.00%) 
Neutropenia  1  0/6 (0.00%)  1/3 (33.33%) 
Cardiac disorders     
Arrythmia  1  1/6 (16.67%)  0/3 (0.00%) 
Bradycardia  1  1/6 (16.67%)  0/3 (0.00%) 
Tachycardia  1  1/6 (16.67%)  0/3 (0.00%) 
Eye disorders     
Vision blurred  1  0/6 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders     
Constipation  1  1/6 (16.67%)  1/3 (33.33%) 
Nausea  1  0/6 (0.00%)  2/3 (66.67%) 
Vomiting  1  0/6 (0.00%)  1/3 (33.33%) 
General disorders     
Asthenia  1  1/6 (16.67%)  0/3 (0.00%) 
Fatigue  1  2/6 (33.33%)  1/3 (33.33%) 
Gait disturbance  1  1/6 (16.67%)  1/3 (33.33%) 
Gravitational edema  1  1/6 (16.67%)  0/3 (0.00%) 
Chills  1  0/6 (0.00%)  1/3 (33.33%) 
Peripheral edema  1  1/6 (16.67%)  1/3 (33.33%) 
Pain  1  1/6 (16.67%)  0/3 (0.00%) 
Pyrexia  1  1/6 (16.67%)  0/3 (0.00%) 
Infections and infestations     
Diverticulitis  1  0/6 (0.00%)  1/3 (33.33%) 
Pneumonia  1  1/6 (16.67%)  0/3 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/6 (16.67%)  0/3 (0.00%) 
Investigations     
Blood creatinine increased  1  0/6 (0.00%)  1/3 (33.33%) 
Blood urea increased  1  0/6 (0.00%)  1/3 (33.33%) 
Weight decreased  1  1/6 (16.67%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/6 (16.67%)  0/3 (0.00%) 
Back pain  1  1/6 (16.67%)  0/3 (0.00%) 
Muscle spasms  1  1/6 (16.67%)  0/3 (0.00%) 
Muscular weakness  1  1/6 (16.67%)  1/3 (33.33%) 
Pain in extremity  1  2/6 (33.33%)  0/3 (0.00%) 
Nervous system disorders     
Balance disorder  1  1/6 (16.67%)  0/3 (0.00%) 
Dizziness  1  1/6 (16.67%)  2/3 (66.67%) 
Dysgeusia  1  1/6 (16.67%)  0/3 (0.00%) 
Peripheral neuropathy  1  6/6 (100.00%)  1/3 (33.33%) 
Renal and urinary disorders     
Pollakiuria  1  0/6 (0.00%)  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/6 (0.00%)  1/3 (33.33%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  2/6 (33.33%)  0/3 (0.00%) 
Vascular disorders     
Hypertension  1  1/6 (16.67%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA®, Version 15
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
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