KPT-330 to Treat Poorly Differentiated Lung and Gastroenteropancreatic Tumors

NCT02250885 | Completed Phase 2

• 1 other identifier: GCC-003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and gastrointestinal and pancreatic neuroendocrine tumors.

Conditions

Carcinoma, Neuroendocrine

Keywords

Selinexor; phase 2; Gabrail

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  To evaluate the efficacy of single agent Selinexor in patients with poorly differentiated lung and gastroenteropancreatic (GEP) neuroendocrine tumors (NET) as determined by overall response rate (ORR) including complete (CR) and partial (PR) response.

  Every 8 weeks from screening until documented disease progression or date of death, whichever occurs first, up to approximately 100 months.

Study Arms (1)

Selinexor (KPT-330)

EXPERIMENTAL

Selinexor will be taken orally at a starting dose of 50mg/m2 twice weekly on weeks 1, 2, and 3 of each 4 week cycle.

Drug: Selinexor

Interventions

Selinexor DRUG

Selective Inhibitor fo Nuclear Export (SINE)

Also known as: KPT-330

Selinexor (KPT-330)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are pregnant or lactating
• 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

Sponsors & Collaborators

• Gabrail Cancer Center Research: lead
• Karyopharm Therapeutics Inc: collaborator

Study Sites (1)

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

selinexor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Nashat Y Gabrail, MD

  Gabrail Cancer Center Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: September 26, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)