Trial Outcomes & Findings for Clinical Trial of Chemotherapy and Bemcentinib for Metastatic Pancreatic Cancer (NCT NCT03649321)
NCT ID: NCT03649321
Last Updated: 2023-11-09
Results Overview
Determine the clinical activity as defined by overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma. The analyses of ORR was performed on the Response Evaluable Population. ORR is defined as the proportion of patients with CR+partial response as their best clinical response.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Results posted on
2023-11-09
Participant Flow
Participant milestones
| Measure |
Phase 1b
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
0
|
|
Overall Study
COMPLETED
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Phase 1b
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Clinical Trial of Chemotherapy and Bemcentinib for Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b
n=9 Participants
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
Total
n=9 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
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
62.3 years
n=5 Participants
|
—
|
62.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
1 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 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
United States
|
9 participants
n=5 Participants
|
—
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.Population: The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
Determine the clinical activity as defined by overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma. The analyses of ORR was performed on the Response Evaluable Population. ORR is defined as the proportion of patients with CR+partial response as their best clinical response.
Outcome measures
| Measure |
Phase 1b
n=7 Participants
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Overall Response Rate (ORR)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.Population: The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
Determine clinical activity of bemcentinib plus chemotherapy as defined by complete response rate (CRR), partial response, stable disease, duration of response - overall response/stable disease, median progression free survival (PFS) and overall survival (OS) rate.
Outcome measures
| Measure |
Phase 1b
n=7 Participants
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Complete Response Rate (CR)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.Population: The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
Determine clinical benefit rate as defined by complete response (CR), Partial Response (PR), and Stable Disease (SD) response rates. Clinical benefit response - percent of CR, PR, and SD.
Outcome measures
| Measure |
Phase 1b
n=7 Participants
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Clinical Benefit Rate
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.Population: 5 patients experienced an adverse event of grade 3 or higher. The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
Assess safety and tolerability of bemcentinib plus chemotherapy in patients with metastatic pancreatic adenocarcinoma and will be graded according to the NCI CTCAE, Version 5
Outcome measures
| Measure |
Phase 1b
n=9 Participants
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Number of Participants With an Adverse Event of Grade 3 or Higher
|
5 Participants
|
0 Participants
|
Adverse Events
Phase 1b
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Phase 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b
n=9 participants at risk
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Immune system disorders
Allergic Reaction
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Infections and infestations
Sepsis
|
22.2%
2/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Localized Edema
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Immune system disorders
Urine Discoloration
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
Other adverse events
| Measure |
Phase 1b
n=9 participants at risk
bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m\^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m\^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
Cisplatin: Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days
|
Phase 2
bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m\^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m\^2 Day 1 /8 /15 every 28 days.
Bemcentinib: 200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxel: 25 mg/m\^2 Day 1 /8 every 21 days or 28 days.
Gemcitabine: Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
4/9 • Number of events 20 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.2%
2/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Hepatobiliary disorders
Alkaline Phosphatase Increased
|
11.1%
1/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Immune system disorders
Allergic Reaction
|
11.1%
1/9 • Number of events 5 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Renal and urinary disorders
Creatinine Increased
|
22.2%
2/9 • Number of events 3 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 3 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • Number of events 5 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
3/9 • Number of events 5 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Cardiac disorders
ECG QT corrected interval prolonged
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
General disorders
Fatigue
|
77.8%
7/9 • Number of events 8 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
GERD
|
44.4%
4/9 • Number of events 4 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
2/9 • Number of events 4 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
2/9 • Number of events 5 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
22.2%
2/9 • Number of events 3 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Investigations
Hyponatremia
|
11.1%
1/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Number of events 6 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Localized Edema
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
44.4%
4/9 • Number of events 6 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Infections and infestations
Mucositis Oral
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
33.3%
3/9 • Number of events 3 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Pain
|
44.4%
4/9 • Number of events 4 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
44.4%
4/9 • Number of events 4 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Vascular disorders
Pulmonary Embolism
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Number of events 4 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Infections and infestations
Sepsis
|
22.2%
2/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
55.6%
5/9 • Number of events 11 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Infections and infestations
Thrush
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 4 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Infections and infestations
Upper Respiratory Infection
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Renal and urinary disorders
Urine Discoloration
|
22.2%
2/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Blood and lymphatic system disorders
WBC Count Decreased
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
11.1%
1/9 • Number of events 2 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
—
0/0 • Adverse event data was collected over a time period of approximately 42 months.
The study was terminated after the Phase 1b completed and prior to Phase 2 initiation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place