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NCT02417753

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

Terminated Phase 2 Results posted Last updated 15 May 2017
What this trial tests

Phase 2 trial testing AZD9150 in Ovarian Cancer in 1 participant. Terminated before completion.

Timeline
3 April 2015
Primary endpoint
7 April 2016
7 April 2016

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1
Start date3 April 2015
Primary completion7 April 2016
Estimated completion7 April 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Ovarian Cancer or Ovarian Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Participants With Serious and Non Serious Adverse Events Secondary · 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 o

GroupValue95% CI
AZD9150 in People With Malignant Ascites1

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months and 15 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AZD9150 in People With Malignant Ascites
Serious: 1/1 (100%)
Deaths: 1/1

Serious adverse events (10 terms)

ReactionSystemAZD9150 in People With Mal…
AscitesGastrointestinal disorders
Atrial fibrillationCardiac disorders
Death NOSGeneral disorders
Edema trunkGeneral disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
HypotensionVascular disorders
IleusGastrointestinal disorders
NauseaGastrointestinal disorders
Upper gastrointestinal hemorrhageGastrointestinal disorders
VomitingGastrointestinal disorders
Other adverse events (24 terms — click to expand)

ReactionSystemAZD9150 in People With Mal…
Activated partial thromboplastin time prolongedInvestigations
Alanine aminotransferase increasedInvestigations
AnemiaBlood and lymphatic system disorders
AnorexiaMetabolism and nutrition disorders
Aspartate aminotransferase increasedInvestigations
ConstipationGastrointestinal disorders
Creatinine increasedInvestigations
DehydrationMetabolism and nutrition disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Edema limbsGeneral disorders
Fibrinogen decreasedInvestigations
HyperkalemiaMetabolism and nutrition disorders
HyperuricemiaMetabolism and nutrition disorders
HypoalbuminemiaMetabolism and nutrition disorders
HypomagnesemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
InsomniaPsychiatric disorders
Lymphocyte count decreasedInvestigations
NauseaGastrointestinal disorders
Platelet count decreasedInvestigations
Pleural effusionRespiratory, thoracic and mediastinal disorders
Sore throatRespiratory, thoracic and mediastinal disorders
Vascular access complicationInjury, poisoning and procedural complications
VomitingGastrointestinal disorders

Most-reported serious reactions: Ascites, Atrial fibrillation, Death NOS, Edema trunk, Generalized muscle weakness, Hypotension, Ileus, Nausea.

Data from ClinicalTrials.gov NCT02417753 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. STAT3 as a potential therapeutic target in triple negative breast cancer: a systematic review.
    Qin JJ, Yan L, Zhang J, Zhang WD. · · 2019 · cited 278× · PMID 31088482 · DOI 10.1186/s13046-019-1206-z
  2. Therapeutic nucleic acids: current clinical status.
    Sridharan K, Gogtay NJ. · · 2016 · cited 153× · PMID 27111518 · DOI 10.1111/bcp.12987
  3. The STAT3 pathway as a therapeutic target in head and neck cancer: Barriers and innovations.
    Geiger JL, Grandis JR, Bauman JE. · · 2016 · cited 150× · PMID 26733183 · DOI 10.1016/j.oraloncology.2015.11.022
  4. Targeting the Microglial Signaling Pathways: New Insights in the Modulation of Neuropathic Pain.
    Popiolek-Barczyk K, Mika J. · · 2016 · cited 140× · PMID 27281131 · DOI 10.2174/0929867323666160607120124
  5. Recent Advances in Oligonucleotide Therapeutics in Oncology.
    Xiong H, Veedu RN, Diermeier SD. · · 2021 · cited 132× · PMID 33804856 · DOI 10.3390/ijms22073295
  6. STAT3 as a mediator of oncogenic cellular metabolism: Pathogenic and therapeutic implications.
    Tošić I, Frank DA. · · 2021 · cited 100× · PMID 34731785 · DOI 10.1016/j.neo.2021.10.003
  7. The Engagement Between MDSCs and Metastases: Partners in Crime.
    Trovato R, Canè S, Petrova V, Sartoris S, et al · · 2020 · cited 56× · PMID 32133298 · DOI 10.3389/fonc.2020.00165
  8. Exploring the clinical value of tumor microenvironment in platinum-resistant ovarian cancer.
    Ghoneum A, Almousa S, Warren B, Abdulfattah AY, et al · · 2021 · cited 53× · PMID 33476723 · DOI 10.1016/j.semcancer.2020.12.024

Verify or expand the search:

Other trials of AZD9150

Trials testing the same drug.

Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02417753.

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