Ovarian CancerPhase 2NCT02417753
AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites
A Phase 2 study testing AZD9150 in people with Ovarian Cancer and Ovarian Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ovarian Cancer, Ovarian Neoplasms, Ascites
- What is being tested?
- AZD9150
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2015to 7 Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients who are receiving any other investigational agents.
- History of prior Janus kinase (JAK) or signal transducer and activator transcription 3 (STAT)3 inhibitor treatment.
- Patients with known brain metastases or spinal cord compression should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patients must not have other invasive malignancies within the past 3 years (with the exception of adequately treated basal or squamous cell skin cancers, carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) of breast).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD9150.
- Incompletely healed surgical incision prior to enrolment
Show all 27Show fewer
- Ongoing therapy with oral or parenteral anticoagulants (e.g., heparin, warfarin). Lowdose anticoagulants for maintenance of catheter patency are not exclusionary.
- Any of the following cardiac criteria:
- Mean resting corrected Q wave and T wave (QT) interval (QTcF) > 480 msec obtained from 3 electrocardiograms (ECGs)
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block
- Patients with uncontrolled hypertension (systolic blood pressure (SBP)> 155, diastolic blood pressure (DBP)> 90), unstable coronary disease (unstable angina, evidence of congestive heart failure (CHF), or myocardial infarction (MI) within 6 months of study)
- New York Heart Association (NYHA) greater than or equal to Grade II or greater.
- History of myocardial infarction within 6months prior to screening.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding
- Human immunodeficiency virus (HIV)-positive patients or with history of hepatitis or with current chronic or active hepatitis. A past history of Hepatitis A is allowed.
- History of recurrent bacterial infections unrelated to hepatocellular carcinoma (HCC) (particularly skin or lung)
- Bacterial peritonitis within 30 days
- History of, or presently active or chronic viral infections (i.e. zoster or hepatitis)
- History of known latent or active tuberculosis, signs of active or latent tuberculosis on chest X-ray, skin test showing an induration of >10 mm or more or according to local recommendations.
- Active bleeding disorders and high likelihood of bleeding or conditions or medications known to increase the risk of bleeding. Patients with bleeding diathesis and subjects who are receiving anticoagulation treatment with INR > 2 are excluded.
- History of recurrent thrombosis or any thrombosis within the past 6 months
- Family history consistent with thrombophilia or hypofibrinolysis
- Patients who have received liver transplantation
- History of clinically significant liver abnormalities other than liver metastasis
- Presence of hepatic encephalopathy within 4 weeks of 1st dose
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of AZD9150, a STAT3 Antisense Oligonucleotide in Malignant Ascites
Background:
- Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer.
Read more
Objective:
- To look at the immune markers the ascites of people with gastrointestinal or ovarian cancer.
Eligibility:
- Adults age 18 and older with a malignancy of the gastrointestinal tract (GI) tract or metastatic ovarian cancer. As a result, they have ascites in the abdomen.
Design:
- Participants will be screened with:
- Medical history, physical exam, and blood tests.
- Echocardiogram: sound waves make images of the heart.
- Electrocardiogram: measures electrical activity of the heart.
- Paracentesis: a needle will be inserted in the abdomen and will remove some of the ascites fluid.
- They may have a tumor biopsy.
- Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in cycle 1 and 4 times all other cycles. Each cycle is 28 days.
- Each cycle, participants will:
- Have a physical exam.
- Have blood tests weekly.
- Be asked about how they feel and any medicines they are taking.
- After every 2 cycles (about every 2 months), participants will have scans and x-rays of their tumor.
- Participants will have paracentesis 2 more times during the study. They will have another echocardiogram.
- At the end of therapy, participants will have a physical exam and blood tests. They will be asked about how they feel and any medicines they are taking.
Read the detailed description
Background:
- Signal transducer and activator of transcription 3 (STAT)3 is considered to be a promising cancer drug target because of its pleiotropic involvement in tumorigenesis. STAT3 not only regulates the expression of many genes which are directly important for the survival of tumor cells, but it is also an important factor in non-tumor cells in the tumor microenvironment involved in immune evasion of tumor cells, angiogenesis, and metastasis.
- AZD9150 is an antisense oligonucleotide designed to target and down-regulate expression of human STAT3 mRNA.
- By focusing on patients with malignant ascites it will be more feasible for us to sample the tumor environment and to do it more frequently than, for example, conventional tumor tissue biopsies. Malignant ascites is a relatively common occurrence in ovarian and gastrointestinal malignancies, impacting greatly on quality of life.
Objectives:
-To measure changes in immune parameters in the malignant ascites of patients with advanced cancer following therapy with AZD9150.
Select Eligibility:
- Age greater than or equal to 18 years.
- Histologically confirmed metastatic ovarian or GI malignancy with malignant ascites. Patients must have ascites amenable for paracentesis.
- Patient that have relapsed or have been refractory to at least one prior chemotherapy regimen, or patients for whom no standard therapy exists
Design:
- Up to N=15 eligible patients will receive AZD9150 at the following schedule:
- Cycle 1 only: AZD9150 will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22.
- Cycle 2 and beyond: AZD9150 will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle.
- Patients will be re-staged every 8 weeks.
- Patients will undergo a baseline pretreatment paracentesis which will be repeated on Cycle 1 Days 8 and 15. An optional paracentesis may be attempted on D57 or off treatment (whichever happens first). Immune subsets analysis at baseline in biopsy/ascites/peripheral blood mononuclear cells (PBMC) and post AZD9150 in surgical specimen, ascites and PBMC will be analyzed. STAT3 activation status will also be assessed in tumor cells isolated from malignant ascites at various time points.
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ascites, Gastrointestinal Cancer, Gastrointestinal Neoplasms
- Being tested
- AZD9150
- Keywords
- PARACENTESIS, STAT3 Antisense Oligonucleotide, Ascites, AZD9150, Surgical Resection
- Medical subject headings
- Ovarian Neoplasms, Ascites, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9150Drug
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
| Study group | Role | What they receive |
|---|---|---|
| AZD9150 in People with Malignant Ascites | Experimental | AZD9150 over a 28 day cycle Receives: Drug: AZD9150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150
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.
Measured: 1.5 years
Secondary outcomes (6)
Effect on Signal Transducer and Activator of Transcription 3(STAT3)-Dependent & Associated Signaling Both in Tumor Cells, Peripheral Blood and the Microenvironment, Including Modulations in Chemokine and Cytokine Response Following Treatment With AZD9150
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).
Measured: 1.5 years
Reduction in Tyrosine-phosphorylated Signal Transducer and Activator of Transcription 3 (STAT3) Phospho- Signal Transducer and Activator of Transcription 3 (p- STAT3) Expression, Comparing Before and After Therapy, in Ascites and Peripheral Blood
Measure the reduction in tyrosine-phosphorylated STAT3 (p=STAT3) expression.
Measured: 1.5 years
Response Rate (RR) in Patients With Malignant Ascites Treated With AZD9150
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.
Measured: 1.5 years
Count of Participants With Serious and Non Serious Adverse Events
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.
Measured: 4 months and 15 days
Progression Free Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150
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).
Measured: 1.5 years
Overall Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150
OS is defined as the time from the first day of treatment to the day of death.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start3 Apr 2015
- Primary completion7 Apr 2016
- Study completion7 Apr 2016
Why it stopped: Study was closed because we could not find these types of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Tim Greten, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Tim F Greten, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417753
- Sponsor's protocol ID
- 150112
- Other IDs
- 15-C-0112
- Status last verified
- May 2017
- First submitted
- 15 Apr 2015
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of AZD9150, a STAT3 Antisense Oligonucleotide in Malignant Ascites
- ClinicalTrials.gov ID
- NCT02417753
- Acronym / sponsor ID
- 150112
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ascites, Gastrointestinal Cancer, Gastrointestinal Neoplasms
- Keywords
- PARACENTESIS, STAT3 Antisense Oligonucleotide, Ascites, AZD9150, Surgical Resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed because we could not find these types of patients.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 Apr 2015 (actual)
- Primary completion
- 7 Apr 2016 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer.
Objective:
- To look at the immune markers the ascites of people with gastrointestinal or ovarian cancer.
Eligibility:
- Adults age 18 and older with a malignancy of the gastrointestinal tract (GI) tract or metastatic ovarian cancer. As a result, they have ascites in the abdomen.
Design:
- Participants will be screened with:
- Medical history, physical exam, and blood tests.
- Echocardiogram: sound waves make images of the heart.
- Electrocardiogram: measures electrical activity of the heart.
- Paracentesis: a needle will be inserted in the abdomen and will remove some of the ascites fluid.
- They may have a tumor biopsy.
- Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in cycle 1 and 4 times all other cycles. Each cycle is 28 days.
- Each cycle, participants will:
- Have a physical exam.
- Have blood tests weekly.
- Be asked about how they feel and any medicines they are taking.
- After every 2 cycles (about every 2 months), participants will have scans and x-rays of their tumor.
- Participants will have paracentesis 2 more times during the study. They will have another echocardiogram.
- At the end of therapy, participants will have a physical exam and blood tests. They will be asked about how they feel and any medicines they are taking.
Detailed description
Background:
- Signal transducer and activator of transcription 3 (STAT)3 is considered to be a promising cancer drug target because of its pleiotropic involvement in tumorigenesis. STAT3 not only regulates the expression of many genes which are directly important for the survival of tumor cells, but it is also an important factor in non-tumor cells in the tumor microenvironment involved in immune evasion of tumor cells, angiogenesis, and metastasis.
- AZD9150 is an antisense oligonucleotide designed to target and down-regulate expression of human STAT3 mRNA.
- By focusing on patients with malignant ascites it will be more feasible for us to sample the tumor environment and to do it more frequently than, for example, conventional tumor tissue biopsies. Malignant ascites is a relatively common occurrence in ovarian and gastrointestinal malignancies, impacting greatly on quality of life.
Objectives:
-To measure changes in immune parameters in the malignant ascites of patients with advanced cancer following therapy with AZD9150.
Select Eligibility:
- Age greater than or equal to 18 years.
- Histologically confirmed metastatic ovarian or GI malignancy with malignant ascites. Patients must have ascites amenable for paracentesis.
- Patient that have relapsed or have been refractory to at least one prior chemotherapy regimen, or patients for whom no standard therapy exists
Design:
- Up to N=15 eligible patients will receive AZD9150 at the following schedule:
- Cycle 1 only: AZD9150 will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22.
- Cycle 2 and beyond: AZD9150 will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle.
- Patients will be re-staged every 8 weeks.
- Patients will undergo a baseline pretreatment paracentesis which will be repeated on Cycle 1 Days 8 and 15. An optional paracentesis may be attempted on D57 or off treatment (whichever happens first). Immune subsets analysis at baseline in biopsy/ascites/peripheral blood mononuclear cells (PBMC) and post AZD9150 in surgical specimen, ascites and PBMC will be analyzed. STAT3 activation status will also be assessed in tumor cells isolated from malignant ascites at various time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD9150 in People with Malignant Ascites | Experimental | Drug: AZD9150AZD9150 over a 28 day cycle |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (27 listed)
- Patients who are receiving any other investigational agents.
- History of prior Janus kinase (JAK) or signal transducer and activator transcription 3 (STAT)3 inhibitor treatment.
- Patients with known brain metastases or spinal cord compression should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patients must not have other invasive malignancies within the past 3 years (with the exception of adequately treated basal or squamous cell skin cancers, carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) of breast).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD9150.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9150AZD9150 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 | Drug | AZD9150 in People with Malignant Ascites |
Primary outcome
Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150
Time frame: 1.5 years
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.
6 secondary outcomes
Effect on Signal Transducer and Activator of Transcription 3(STAT3)-Dependent & Associated Signaling Both in Tumor Cells, Peripheral Blood and the Microenvironment, Including Modulations in Chemokine and Cytokine Response Following Treatment With AZD9150
Time frame: 1.5 years
Reduction in Tyrosine-phosphorylated Signal Transducer and Activator of Transcription 3 (STAT3) Phospho- Signal Transducer and Activator of Transcription 3 (p- STAT3) Expression, Comparing Before and After Therapy, in Ascites and Peripheral Blood
Time frame: 1.5 years
Response Rate (RR) in Patients With Malignant Ascites Treated With AZD9150
Time frame: 1.5 years
Count of Participants With Serious and Non Serious Adverse Events
Time frame: 4 months and 15 days
Progression Free Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150
Time frame: 1.5 years
Overall Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150
Time frame: 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim F Greten, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD9150 in people with Ovarian Cancer and Ovarian Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150 (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.