Trial Outcomes & Findings for AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites (NCT NCT02417753)

Last Updated: 2017-05-15

Results Overview

Participants were to undergo research paracentesis. Ascitic fluid was to be obtained and processed for changes in the percentages of memory cluster of differentiation 8 (CD8) + cells, regulatory T cells, plasmacytoid dendritic cell (pDC), B cells and natural killer (NK) cells will be analyzed by flow cytometry.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

1.5 years

Results posted on

2017-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	AZD9150 in People With Malignant Ascites AZD9150 over a 28 day cycle AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD9150 in People With Malignant Ascites AZD9150 over a 28 day cycle AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle
Overall Study Death	1

Baseline Characteristics

AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD9150 in People With Malignant Ascites n=1 Participants AZD9150 over a 28 day cycle AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	60.4 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1.5 years

Population: This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1.5 years

Population: This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.

Serum samples were to be collected from participants and assessed for interferon, cytokine and chemokine levels including interferon, ϒ-interferon inducible protein (IP-10), monocyte chemoattractant protein 1 (MCP-1), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 10 (IL-10), and interleukin 12/p70 (IL-12/p70).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1.5 years

Population: This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.

Measure the reduction in tyrosine-phosphorylated STAT3 (p=STAT3) expression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1.5 years

Population: This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.

Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is measured from the time measurement criteria are met for complete response or partial response (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months and 15 days

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	AZD9150 in People With Malignant Ascites n=1 Participants AZD9150 over a 28 day cycle AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle
Count of Participants With Serious and Non Serious Adverse Events	1 Participants

SECONDARY outcome

Timeframe: 1.5 years

Population: This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.

PFS is the time interval from start of treatment to documented evidence of progressive disease. Progressive disease was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). in addition to the relative increase of 29%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1.5 years

Population: This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.

OS is defined as the time from the first day of treatment to the day of death.

Outcome measures

Outcome data not reported

Adverse Events

AZD9150 in People With Malignant Ascites

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	AZD9150 in People With Malignant Ascites n=1 participants at risk AZD9150 over a 28 day cycle AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle
Gastrointestinal disorders Ascites	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Cardiac disorders Atrial fibrillation	100.0% 1/1 • Number of events 1 • 4 months and 15 days
General disorders Death NOS	100.0% 1/1 • Number of events 1 • 4 months and 15 days
General disorders Edema trunk	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Musculoskeletal and connective tissue disorders Generalized muscle weakness	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Vascular disorders Hypotension	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Gastrointestinal disorders Ileus	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Gastrointestinal disorders Upper gastrointestinal hemorrhage	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Gastrointestinal disorders Vomiting	100.0% 1/1 • Number of events 1 • 4 months and 15 days

Other adverse events

Other adverse events
Measure	AZD9150 in People With Malignant Ascites n=1 participants at risk AZD9150 over a 28 day cycle AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle
Investigations Activated partial thromboplastin time prolonged	100.0% 1/1 • Number of events 2 • 4 months and 15 days
Investigations Alanine aminotransferase increased	100.0% 1/1 • Number of events 2 • 4 months and 15 days
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 2 • 4 months and 15 days
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • Number of events 2 • 4 months and 15 days
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Number of events 4 • 4 months and 15 days
Gastrointestinal disorders Constipation	100.0% 1/1 • Number of events 3 • 4 months and 15 days
Investigations Creatinine increased	100.0% 1/1 • Number of events 3 • 4 months and 15 days
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 3 • 4 months and 15 days
General disorders Edema limbs	100.0% 1/1 • Number of events 2 • 4 months and 15 days
Investigations Fibrinogen decreased	100.0% 1/1 • Number of events 2 • 4 months and 15 days
Metabolism and nutrition disorders Hyperkalemia	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Metabolism and nutrition disorders Hyperuricemia	100.0% 1/1 • Number of events 4 • 4 months and 15 days
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 1/1 • Number of events 4 • 4 months and 15 days
Metabolism and nutrition disorders Hypomagnesemia	100.0% 1/1 • Number of events 2 • 4 months and 15 days
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • Number of events 3 • 4 months and 15 days
Psychiatric disorders Insomnia	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 6 • 4 months and 15 days
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Investigations Platelet count decreased	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Respiratory, thoracic and mediastinal disorders Sore throat	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Injury, poisoning and procedural complications Vascular access complication	100.0% 1/1 • Number of events 1 • 4 months and 15 days
Gastrointestinal disorders Vomiting	100.0% 1/1 • Number of events 1 • 4 months and 15 days

Additional Information

Dr. Tim Greten

National Cancer Institute

Phone: 301-451-4723

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place