A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers
Status: | Completed |
---|---|
Conditions: | Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/7/2017 |
Start Date: | September 2014 |
End Date: | August 2016 |
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
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.
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.
Subjects enrolled in this PNET/GI-NET study (OX4218s) will receive weekly dosing with
fosbretabulin for up to 3 cycles or approximately 9 weeks.
fosbretabulin for up to 3 cycles or approximately 9 weeks.
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)
We found this trial at
5
sites
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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