KPT-330 to Treat Poorly Differentiated Lung and Gastroenteropancreatic Tumors
Carcinoma, Neuroendocrine
Conditions: official terms
Carcinoma, Neuroendocrine
Conditions: Keywords
Selinexor, phase 2, Gabrail
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Selinexor
Type: Drug
Overall Status
Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and gastrointestinal and pancreatic neuroendocrine tumors.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Written informed consent in accordance with federal, local, and institutional guidelines

- Age ≥18 years

- Patients must have a tissue diagnosis of any of the following:

- Small cell lung cancer (SCLC) or poorly differentiated gastroenteropancreatic neuroendocrine tumor (GEP-NET)

- Poorly differentiated metastatic neuroendocrine tumors of unknown primary origin

- Measurable disease: Any primary and/or metastatic mass reproducibly measurable in one or two diameters by RECIST 1.1 parameters by cat scan (CT) scan.

- Objective evidence of tumor progression within 4 months prior to study entry, as defined by serial cat scan (CT) per RECIST 1.1 criteria. (At least a 20% increase in the sum of diameters of target lesions. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression).

- Patients must have received at least one prior line of chemotherapy and must have exhausted any other standard-of-care treatment option.

- Prior radiation and surgery is allowed. At least 3 weeks should have elapsed from surgery, chemotherapy, hepatic embolization/ chemoembolization or radioactive isotopes (i.e. Yttrium 90). In any case, disease progression must be documented after treatment.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Concomitant octreotide treatment for carcinoid syndrome is allowed for patients whose tumor has progressed while on octreotide. Patients must have been on a stable dose of octreotide two weeks prior to enrollment and must remain on a stable dose during the study.

- Hematological function:

- Total white blood cell count (WBC) > 2,000/mm³

- Absolute neutrophil (ANC) > 1,000/mm³

- Platelet >100,000mm³

- Adequate hepatic function within 14 days prior to C1D1: total direct bilirubin <2 times the upper limit of normal (ULN; 1.0 mg/dL) and alanine aminotransferase (ALT) <2.5 times ULN (30 U/L). In the case of known (radiological and/or biopsy documented) liver metastasis, ALT <5.0 times ULN is acceptable.

- Adequate renal function within 7 days prior to C1D1: estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault: (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female.

- Blood electrolytes should be within the following normal limits:

Bicarbonate (total) 18-30 mEq/L Sodium 135-147 mEq/L Potassium 3.5-5.5 mEq/L Phosphorus 1.8-2.3 mEq/L Magnesium 1.5-3.0 mEq/L Chloride 98-106 mEq/L Calcium (total) 4.5-5.5 mEq/L

- Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.

Exclusion Criteria:

- Patients who are pregnant or lactating

- Patients with the following tumor types: lung carcinoid, pheochromocytomas, paragangliomas, medullary thyroid carcinomas, any other tumors with neuroendocrine features not listed in the inclusion criteria

- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤3 weeks prior to C1D1

- Major surgery ≤3 weeks prior to C1D1

- Unstable cardiovascular function:

- Congestive heart failure (CHF) of NYHA Class ≥3 OR

- Myocardial infarction (MI) within 3 months

- Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study

- Known to be human immunodeficiency virus (HIV) seropositive

- Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV RNA) or HBsAg (HBV surface antigen)

- Any underlying condition that would significantly interfere with the absorption of an oral medication

- Patients who have active central nervous system (CNS) malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. Patient with malignant cells in their cerebrospinal fluid (CSF) without CNS symptom may be included.

- Serious psychiatric or medical conditions that could interfere with treatment

- Patients with coagulation problems and active bleeding in the last month (peptic ulcer, epistaxis, spontaneous bleeding)

- Patients with signs of gastrointestinal obstruction or uncontrolled vomiting or diarrhea (>3 episodes/week) with electrolyte abnormalities

- Concurrent therapy with approved or investigational anticancer therapeutic agents other than glucocorticoids

- Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Gabrail Cancer Center Research
Canton, Ohio, United States
Status: Recruiting
Contact: Carrie L Smith, RN - 330-492-3345 -
Start Date
August 2014
Completion Date
June 2016
Gabrail Cancer Center Research
Gabrail Cancer Center Research
Record processing date processed this data on July 28, 2015 page