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Carcinoma, NeuroendocrinePhase 2NCT02250885

KPT-330 to Treat Poorly Differentiated Lung and Gastroenteropancreatic Tumors

A Phase 2 study testing Selinexor in people with Carcinoma, Neuroendocrine, run by Gabrail Cancer Center Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and gastrointestinal and pancreatic neuroendocrine tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Neuroendocrine
What is being tested?
Selinexor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Aug 2014to Aug 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

Other trials in United States

About this study

Official title: Investigator Initiated, Phase 2 Clinical Trial of Selinexor (KPT-330) for the Treatment of Poorly Differentiated Lung and Gastroenteropancreatic Tumors

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

Read the detailed description

Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and gastrointestinal and pancreatic neuroendocrine tumors in adult patients age >/= to 18.

Being tested
Selinexor
Keywords
Selinexor, phase 2, Gabrail
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    Also called KPT-330

    Selective Inhibitor fo Nuclear Export (SINE)

Study groups in NCT02250885
Study groupRoleWhat they receive
Selinexor (KPT-330)ExperimentalSelinexor will be taken orally at a starting dose of 50mg/m2 twice weekly on weeks 1, 2, and 3 of each 4 week cycle.
Receives: Drug: Selinexor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02250885
Sponsor's protocol ID
GCC-003
Status last verified
Sep 2019
First submitted
21 Aug 2014
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor in people with Carcinoma, Neuroendocrine, run by Gabrail Cancer Center Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Every 8 weeks from screening until documented disease progression or date of death, whichever occurs first, up to approximately 100 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02250885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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