Trial Outcomes & Findings for TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer (NCT NCT04887506)
NCT ID: NCT04887506
Last Updated: 2024-01-16
Results Overview
The primary endpoint was the between group comparison of serum testosterone levels for the average of levels on Days 9 and 10 (rounded-up) for mCRPC patients.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
Average over Day 9 and Day 10
Results posted on
2024-01-16
Participant Flow
In total, 107 patients were randomized, and 103 patients received at least 1 dose of study medication (4 patients randomized to the R-AA arm were discontinued before receiving any study medication due to adverse event \[n=1\], lab result \[n=1\] and subject withdrawal \[n=2\]).
Participant milestones
| Measure |
TAVT-45
TAVT-45 administered twice daily as a 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5mg once or twice daily, depending on prostate cancer population). TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for 84 days.
TAVT-45: 250 mg abiraterone acetate granules for oral suspension in a sachet, administered twice daily.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
Reference Abiraterone Acetate (Zytiga®) - R-AA
Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population). R-AA administered once daily either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for 84 days.
Zytiga: 500 mg tablet, administered twice daily.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
Modified Intent-to-treat (mITT) Population
|
54
|
49
|
|
Overall Study
COMPLETED
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
TAVT-45
TAVT-45 administered twice daily as a 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5mg once or twice daily, depending on prostate cancer population). TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for 84 days.
TAVT-45: 250 mg abiraterone acetate granules for oral suspension in a sachet, administered twice daily.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
Reference Abiraterone Acetate (Zytiga®) - R-AA
Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population). R-AA administered once daily either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for 84 days.
Zytiga: 500 mg tablet, administered twice daily.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Other - Not Reported
|
1
|
1
|
Baseline Characteristics
TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
TAVT-45
n=54 Participants
TAVT-45 administered twice daily as a 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5mg once or twice daily, depending on prostate cancer population). TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for 84 days.
TAVT-45: 250 mg abiraterone acetate granules for oral suspension in a sachet, administered twice daily.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
Reference Abiraterone Acetate (Zytiga®) - R-AA
n=49 Participants
Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population). R-AA administered once daily either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for 84 days.
Zytiga: 500 mg tablet, administered twice daily.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Continuous
|
74.5 years
STANDARD_DEVIATION 8.45 • n=5 Participants
|
74.9 years
STANDARD_DEVIATION 8.40 • n=7 Participants
|
74.7 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
16 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Prostate Cancer Type
metastatic castrate resistant prostate cancer (mCRPC)
|
33 participants
n=5 Participants
|
30 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Prostate Cancer Type
metastatic castrate sensitive prostate cancer (mCSPC)
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Gleason score
Low (<7)
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Gleason score
Medium (7)
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Gleason score
High (8-10)
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Gleason score
Missing
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average over Day 9 and Day 10Population: The mCRPC ITT (CR-ITT) population was a subset of the mITT population (all randomized patients who received at least one dose of study medication) and included mCRPC patients only.
The primary endpoint was the between group comparison of serum testosterone levels for the average of levels on Days 9 and 10 (rounded-up) for mCRPC patients.
Outcome measures
| Measure |
TAVT-45 CR-ITT
n=32 Participants
All patients in the CR-ITT population treated with TAVT-45.
|
R-AA CR-ITT
n=29 Participants
All patients in the CR-ITT population treated with R-AA.
|
|---|---|---|
|
Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CR-ITT
|
1.0000 ng/dL
Interval 1.0 to 1.0
|
1.0000 ng/dL
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Average over Day 9 and Day 10Population: The mCSPC ITT (CS-ITT) population was a subset of the mITT population and included mCSPC patients only.
This was a supplementary analysis of equivalence, with a between group comparison of serum testosterone for the Days 9 and10 average (rounded-up) values for mCSPC patients treated with either TAVT-45 or R-AA.
Outcome measures
| Measure |
TAVT-45 CR-ITT
n=21 Participants
All patients in the CR-ITT population treated with TAVT-45.
|
R-AA CR-ITT
n=19 Participants
All patients in the CR-ITT population treated with R-AA.
|
|---|---|---|
|
Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CS-ITT
|
1.01179 ng/dL
Interval 0.98533 to 1.03896
|
1.03758 ng/dL
Interval 1.00899 to 1.06697
|
SECONDARY outcome
Timeframe: Average over Day 9 and Day 10Population: mITT population: all randomized patients who received at least one dose of study medication.
Supplementary analysis of equivalence of TAVT-45 and R-AA on Days 9 and 10 average (rounded-up) values in the mITT population (including mCRPC and mCSPC patients).
Outcome measures
| Measure |
TAVT-45 CR-ITT
n=54 Participants
All patients in the CR-ITT population treated with TAVT-45.
|
R-AA CR-ITT
n=49 Participants
All patients in the CR-ITT population treated with R-AA.
|
|---|---|---|
|
Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), mITT
|
1.00410 ng/dL
Interval 0.99406 to 1.01425
|
1.01469 ng/dL
Interval 1.00401 to 1.02548
|
SECONDARY outcome
Timeframe: Response at any time over the 84-day post-treatment period.Population: mITT population: all randomized patients who received at least one dose of study medication.
The PSA-50 response is defined as a decrease of ≥ 50% in prostate-specific antigen (PSA) levels from baseline.
Outcome measures
| Measure |
TAVT-45 CR-ITT
n=54 Participants
All patients in the CR-ITT population treated with TAVT-45.
|
R-AA CR-ITT
n=49 Participants
All patients in the CR-ITT population treated with R-AA.
|
|---|---|---|
|
Percent of Subjects With PSA-50 Response, mITT
|
47 Participants
|
39 Participants
|
Adverse Events
TAVT-45
Serious events: 5 serious events
Other events: 38 other events
Deaths: 1 deaths
R-AA (Zytiga)
Serious events: 3 serious events
Other events: 36 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TAVT-45
n=54 participants at risk
TAVT-45: 500 mg administered as 250 mg tablet twice daily (250 mg abiraterone acetate granules for oral suspension in a sachet, reconstituted in water or specified fruit juice \[orange juice\]) + Prednisone (5mg once or twice daily, depending on prostate cancer population).
TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for up to 84 days.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
R-AA (Zytiga)
n=49 participants at risk
R-AA: 1000 mg administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population).
R-AA administered either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for up to 84 days.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/54 • From baseline to end of treatment (84 days)
|
2.0%
1/49 • Number of events 1 • From baseline to end of treatment (84 days)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/54 • From baseline to end of treatment (84 days)
|
2.0%
1/49 • Number of events 1 • From baseline to end of treatment (84 days)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Cardiac disorders
Myocardial ischaemia
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/54 • From baseline to end of treatment (84 days)
|
2.0%
1/49 • Number of events 1 • From baseline to end of treatment (84 days)
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
Other adverse events
| Measure |
TAVT-45
n=54 participants at risk
TAVT-45: 500 mg administered as 250 mg tablet twice daily (250 mg abiraterone acetate granules for oral suspension in a sachet, reconstituted in water or specified fruit juice \[orange juice\]) + Prednisone (5mg once or twice daily, depending on prostate cancer population).
TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for up to 84 days.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
R-AA (Zytiga)
n=49 participants at risk
R-AA: 1000 mg administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population).
R-AA administered either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for up to 84 days.
Prednisone: mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
9.3%
5/54 • Number of events 6 • From baseline to end of treatment (84 days)
|
10.2%
5/49 • Number of events 5 • From baseline to end of treatment (84 days)
|
|
Investigations
Blood alkaline phosphatase increased
|
7.4%
4/54 • Number of events 4 • From baseline to end of treatment (84 days)
|
10.2%
5/49 • Number of events 6 • From baseline to end of treatment (84 days)
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
3/54 • Number of events 4 • From baseline to end of treatment (84 days)
|
6.1%
3/49 • Number of events 3 • From baseline to end of treatment (84 days)
|
|
Vascular disorders
Hypertension
|
16.7%
9/54 • Number of events 11 • From baseline to end of treatment (84 days)
|
14.3%
7/49 • Number of events 10 • From baseline to end of treatment (84 days)
|
|
Vascular disorders
Hot flush
|
9.3%
5/54 • Number of events 5 • From baseline to end of treatment (84 days)
|
4.1%
2/49 • Number of events 2 • From baseline to end of treatment (84 days)
|
|
General disorders
Asthenia
|
5.6%
3/54 • Number of events 3 • From baseline to end of treatment (84 days)
|
8.2%
4/49 • Number of events 6 • From baseline to end of treatment (84 days)
|
|
General disorders
Oedema peripheral
|
3.7%
2/54 • Number of events 2 • From baseline to end of treatment (84 days)
|
10.2%
5/49 • Number of events 5 • From baseline to end of treatment (84 days)
|
|
General disorders
Fatigue
|
5.6%
3/54 • Number of events 3 • From baseline to end of treatment (84 days)
|
6.1%
3/49 • Number of events 4 • From baseline to end of treatment (84 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/54 • Number of events 1 • From baseline to end of treatment (84 days)
|
6.1%
3/49 • Number of events 3 • From baseline to end of treatment (84 days)
|
|
Gastrointestinal disorders
Constipation
|
7.4%
4/54 • Number of events 4 • From baseline to end of treatment (84 days)
|
4.1%
2/49 • Number of events 2 • From baseline to end of treatment (84 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
3/54 • Number of events 4 • From baseline to end of treatment (84 days)
|
6.1%
3/49 • Number of events 3 • From baseline to end of treatment (84 days)
|
|
Gastrointestinal disorders
Nausea
|
5.6%
3/54 • Number of events 3 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Renal and urinary disorders
Haematuria
|
7.4%
4/54 • Number of events 4 • From baseline to end of treatment (84 days)
|
2.0%
1/49 • Number of events 1 • From baseline to end of treatment (84 days)
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
3/54 • Number of events 3 • From baseline to end of treatment (84 days)
|
0.00%
0/49 • From baseline to end of treatment (84 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
3/54 • Number of events 3 • From baseline to end of treatment (84 days)
|
6.1%
3/49 • Number of events 3 • From baseline to end of treatment (84 days)
|
|
Infections and infestations
COVID-19
|
11.1%
6/54 • Number of events 6 • From baseline to end of treatment (84 days)
|
4.1%
2/49 • Number of events 2 • From baseline to end of treatment (84 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/54 • From baseline to end of treatment (84 days)
|
10.2%
5/49 • Number of events 5 • From baseline to end of treatment (84 days)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/54 • From baseline to end of treatment (84 days)
|
8.2%
4/49 • Number of events 5 • From baseline to end of treatment (84 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place