Trial Outcomes & Findings for Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer (NCT NCT05021900)
NCT ID: NCT05021900
Last Updated: 2024-08-13
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Approximately 6 months
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Tenalisib 800 mg BID
Tenalisib: Tenalisib will be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
Tenalisib: Tenalisib will be administered 1200mg BID, orally
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Tenalisib 800 mg BID
n=20 Participants
Tenalisib: Tenalisib will be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=20 Participants
Tenalisib: Tenalisib will be administered 1200mg BID, orally
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.27 years
n=5 Participants
|
64.21 years
n=7 Participants
|
63.18 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Tenalisib 800 mg BID
n=20 Participants
Tenalisib was be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=20 Participants
Tenalisib was administered 1200mg BID, orally
|
|---|---|---|
|
Percentage of Patients Without Disease Progression
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Approximately 18 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Tenalisib 800 mg BID
n=20 Participants
Tenalisib was be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=20 Participants
Tenalisib was administered 1200mg BID, orally
|
|---|---|---|
|
Overall Response Rate (ORR)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Approximately 18 monthsIt is defined as sum of CR, PR and SD rates
Outcome measures
| Measure |
Tenalisib 800 mg BID
n=20 Participants
Tenalisib was be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=20 Participants
Tenalisib was administered 1200mg BID, orally
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Approximately 18 monthsPFS is measured from the time of first dose of study drug to radiographic documentation of disease progression or death due to any cause.
Outcome measures
| Measure |
Tenalisib 800 mg BID
n=16 Participants
Tenalisib was be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=19 Participants
Tenalisib was administered 1200mg BID, orally
|
|---|---|---|
|
Progression Free Survival (PFS).
|
170 days
Interval 29.0 to 513.0
|
170 days
Interval 38.0 to 454.0
|
SECONDARY outcome
Timeframe: Approximately 18 monthsAny untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product.
Outcome measures
| Measure |
Tenalisib 800 mg BID
n=20 Participants
Tenalisib was be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=20 Participants
Tenalisib was administered 1200mg BID, orally
|
|---|---|---|
|
Treatment Emergent Adverse Events (TEAEs)
|
15 Participants
|
17 Participants
|
Adverse Events
Tenalisib 800 mg BID
Serious events: 5 serious events
Other events: 15 other events
Deaths: 2 deaths
Tenalisib 1200 mg BID
Serious events: 1 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tenalisib 800 mg BID
n=20 participants at risk
Tenalisib: Tenalisib will be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=20 participants at risk
Tenalisib: Tenalisib will be administered 1200mg BID, orally
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
0.00%
0/20 • Approximately 18 months
|
|
Infections and infestations
COVID-19
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
0.00%
0/20 • Approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
10.0%
2/20 • Number of events 2 • Approximately 18 months
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
|
General disorders
Death
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
0.00%
0/20 • Approximately 18 months
|
Other adverse events
| Measure |
Tenalisib 800 mg BID
n=20 participants at risk
Tenalisib: Tenalisib will be administered 800mg BID, orally
|
Tenalisib 1200 mg BID
n=20 participants at risk
Tenalisib: Tenalisib will be administered 1200mg BID, orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Number of events 5 • Approximately 18 months
|
15.0%
3/20 • Number of events 6 • Approximately 18 months
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
15.0%
3/20 • Number of events 4 • Approximately 18 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
40.0%
8/20 • Number of events 21 • Approximately 18 months
|
60.0%
12/20 • Number of events 20 • Approximately 18 months
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
8/20 • Number of events 16 • Approximately 18 months
|
50.0%
10/20 • Number of events 13 • Approximately 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
8/20 • Number of events 14 • Approximately 18 months
|
40.0%
8/20 • Number of events 12 • Approximately 18 months
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
2/20 • Number of events 3 • Approximately 18 months
|
15.0%
3/20 • Number of events 3 • Approximately 18 months
|
|
Investigations
Blood bilirubin increased
|
15.0%
3/20 • Number of events 3 • Approximately 18 months
|
0.00%
0/20 • Approximately 18 months
|
|
Investigations
Blood cholesterol increased
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
10.0%
2/20 • Number of events 4 • Approximately 18 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/20 • Approximately 18 months
|
10.0%
2/20 • Number of events 2 • Approximately 18 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.0%
1/20 • Number of events 8 • Approximately 18 months
|
5.0%
1/20 • Number of events 4 • Approximately 18 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • Approximately 18 months
|
10.0%
2/20 • Number of events 2 • Approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.0%
3/20 • Number of events 3 • Approximately 18 months
|
10.0%
2/20 • Number of events 2 • Approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • Number of events 2 • Approximately 18 months
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
5.0%
1/20 • Number of events 1 • Approximately 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place