A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers

NCT ID: NCT02132468

Last Updated: 2017-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Neuroendocrine Tumors

Keywords

PNET; GI-NET; neuroendocrine; carcinoid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fosbretabulin tromethamine

Fosbretabulin 90 mg/vial; 60 mg/m2, IV infusion over 10 minutes; 1x/wk; three 3-week cycles

Group Type: EXPERIMENTAL

fosbretabulin tromethamine

Intervention Type: DRUG

60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity

Interventions

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

Intervention Type: DRUG

Other Intervention Names

fosbretabulin, combretastatin A4-phosphate, CA4P

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mateon Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University School of Medicine

Stanford, California, United States

Markey Cancer Center, Clinical Research Office

Lexington, Kentucky, United States

Montefiore

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Froedtert Hospital, Medicial College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

OX4218s

Identifier Type: -

Identifier Source: org_study_id