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A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers (GI-NETorPNET)

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ClinicalTrials.gov Identifier: NCT02132468
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : October 19, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Mateon Therapeutics

Tracking Information
First Submitted Date  ICMJE May 2, 2014
First Posted Date  ICMJE May 7, 2014
Results First Submitted Date  ICMJE September 21, 2017
Results First Posted Date  ICMJE October 19, 2017
Last Update Posted Date December 5, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline [ Time Frame: Baseline and 4 months ]
    The mean change from baseline in chromogranin A (CgA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.
  • Number of Participants With Improved, Stable, or Worsened Change In 5-hydroxyindoleacetic Acid (5-HIAA) Biomarker Levels From Baseline [ Time Frame: Baseline and 4 months ]
    The mean change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.
  • Number of Participants With Improved, Stable, or Worsened Change In Serotonin Biomarker Levels From Baseline [ Time Frame: Baseline and 4 months ]
    The mean change from baseline in serotonin biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
Change from one or more baseline biomarker values for each patient to each study visit and study end [ Time Frame: 4 months ]
Change History Complete list of historical versions of study NCT02132468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1 [ Time Frame: Baseline and 4 months ]
The objective response rate (complete response, partial response, progressive disease, or stable disease) was determined by the investigator assessment of the participant's CT or MRI using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) for target lesions. Partial Response (PR) is when there is at least 30% decrease in sum of the longest diameter of the target lesions. Progressive Disease (PD) is when there is at least 20% increase in the sum of the longest diameter of the target lesions, as well as an absolute increase of at least 5 mm (including appearance of new lesions). Stable Disease (SD) is when there neither a PR nor PD is noted.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers
Official Title  ICMJE A Ph 2 Study to Investigate the Safety and Activity of Fosbretabulin Tromethamine (CA4P) in the Treatment of Well-Differentiated, Low-to-Intermediate-Grade Unresectable, Recurrent or Metastatic PNET or GI-NET Neuroendocrine Tumors/Carcinoid With Elevated Biomarkers
Brief Summary This study will investigate the safety, symptoms and biomarker response of subjects with biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic pancreatic neuroendocrine tumors (PNETs) or or Gastrointestinal Neuroendocrine tumors (GI-NETs) with elevated biochemical markers who have relapsed during or after receiving prior standard of care therapies, including octreotide, chemotherapy or targeted therapy.
Detailed Description Subjects enrolled in this PNET/GI-NET study (OX4218s) will receive weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: fosbretabulin tromethamine
60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
Other Name: fosbretabulin, combretastatin A4-phosphate, CA4P
Study Arms  ICMJE Experimental: fosbretabulin tromethamine
Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles
Intervention: Drug: fosbretabulin tromethamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2016)
18
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2014)
20
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to read, understand and provide written consent to participate in the study
  • Age ≥ 18 years
  • Biopsy-proven well-differentiated, low-to-intermediate-grade PNET or GI-NET with elevated (> ULN) biomarkers (serotonin, 5-hydroxyindoleacetic acid (5-HIAA), chromogranin A (CgA), neurokinin A, and neuron-specific enolase (NSE))
  • Life expectancy > 12 weeks
  • Must have received or may still be receiving one or more therapies including octreotide or serotonin synthesis inhibitor (SSI) or other somatostatin analogues
  • Confirmed progressive disease within 18 months of enrollment on study
  • Recovered from prior radiation therapy or surgery
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500/µL (without growth factors)
  • Platelet count ≥ 100,000/µL
  • Adequate renal function as evidenced by serum creatinine

    ≤ 2.0 mg/dL (177 µmol/L)

  • Adequate hepatic function: serum total bilirubin ≤ 2X greater than the upper limit of normal (ULN) (≤ 3X ULN in subjects with liver metastases), aspartate aminotransferase) AST) / alanine aminotransferase (AST) ≤ 2X the ULN for the local reference lab (≤ 5X the ULN for subjects with liver metastases)
  • Disease that can be assessed (evaluable) with imaging (CT, MRI, PET, radionuclide imaging or other imaging modality)
  • Women of childbearing potential as well as fertile men and their partners must use an effective method of birth control

Exclusion Criteria:

  • Inadequately controlled hypertension defined as BP > 150/100 mm Hg despite medication
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Recent history (within 6 months of start of screening) of unstable angina pectoris pattern, myocardial infarction (including non-Q wave MI), or NYHA (New York Heart Association) Class III and IV Congestive Heart Failure (CHF)
  • Subjects who have clinical evidence of carcinoid-induced heart disease
  • History of prior cerebrovascular accident (CVA), including transient ischemic attach (TIA)
  • Known central nervous system (CNS) disease except for treated brain metastasis
  • History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG
  • Corrected QT interval (QTc) > 480 msec
  • Ongoing treatment with any drugs known to prolong the QTc interval, including anti-arrhythmic medications (stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed))
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Significant vascular disease or recent peripheral arterial thrombosis
  • Known intolerance of or hypersensitivity to fosbretabulin
  • History of solid organ transplant or bone marrow transplant
  • Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
  • High grade or poorly differentiated NET
  • NET tumor other than PNET or GI-NET
  • No elevated biomarker (>ULN) that can be followed
  • Received regional hepatic infusion therapy within 6 months of enrollment (RFA allowed >6 months prior to enrollment)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02132468
Other Study ID Numbers  ICMJE OX4218s
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mateon Therapeutics
Study Sponsor  ICMJE Mateon Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mateon Therapeutics
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP