AzTrials
AzTrials

ThymomaPhase 2SELECTNCT03193437

Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy

A Phase 2 study testing Open Label Selinexor in people with Thymoma and Advanced Thymic Epithelial Tumor, run by Georgetown University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thymoma, Advanced Thymic Epithelial Tumor
What is being tested?
Open Label Selinexor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesUnited States
Study dates
3 Apr 2018to 31 Jan 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed advanced TET (thymoma)
  • Progression after Primary Chemotherapy
  • No more than two previous lines (Neoadjuvant or chemoradiotherapy will count as one line if disease progression has occurred within 6 months)
  • Inoperable per local Investigator (Masaoka Stage III or IV)
  • Progression after treatment with least one platinum containing chemotherapy regimen
  • Measurable disease (RECIST 1.1)
Show all 16Show fewer
  • Age ≥18 years
  • ECOG PS <2
  • Patients must have recovered from the toxic effects of prior therapy at the time of initiation of the study drug unless toxicity is stable.
  • A 4 weeks or five half lives interval from any investigational agents or cytotoxic chemotherapy to start of study is required
  • Signed informed consent
  • Adequate bone marrow function and organ function:
  • Hematopoietic function: total white blood cell count (WBC) ≥ 3000/mm³, absolute neutrophil count (ANC) ≥ 1500/mm³, platelet count ≥ 100,000/mm²; Hemoglobin > 9.0 gm/dL
  • Hepatic function: bilirubin < 1.5 times the upper limit of normal (ULN), ALT < 2.5 times ULN or ALT < 5.0 times ULN in the presence of liver metastases
  • Creatinine clearance > 30 ml/min according to Cockcroft-Gault
  • Patients of childbearing potential must agree to use adequate birth control during and for 7 months after participation in this study

Who cannot join

  • No significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy, including
  • Unstable cardiovascular function
  • Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
  • Markedly decreased visual acuity
  • Active infection requiring intravenous antibiotics
  • Pregnancy or breast-feeding
Show all 13Show fewer
  • Symptomatic brain metastasis requiring corticosteroids
  • Uncontrolled autoimmune disorders. Patients with autoimmune disorders under control on medication may be included. Patients with pure red cell aplasia may be included if haemoglobin levels are relatively stable on transfusions or medication
  • Significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications
  • No dehydration of NCI-CTCAE grade ≥ 1
  • Serious psychiatric or medical conditions that could interfere with treatment.
  • No history of organ allograft
  • No concurrent therapy with approved or investigational anticancer therapeutics

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • John Theurer Cancer Center - Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase 2, Open-label Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumor (TET) Progressing After Primary Chemotherapy (SELECT)

The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen.

This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (25 patients):

Read more

There are two study arms:

Arm A: Thymoma

  • Stage 1: 15 patients
  • Stage 2: 10 patients

Arm B: Thymic carcinoma

  • Stage 1: 15 patients
  • Stage 2: 10 patients
Being tested
Open Label Selinexor
Keywords
Thymus, Selinexor, KPT-330
Medical subject headings
Thymoma

What participants receive

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

  • Open Label SelinexorDrug

    Also called KPT-330

    Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.

Study groups in NCT03193437
Study groupRoleWhat they receive
SelinexorExperimentalOpen Label Selinexor 40 mg
Receives: Drug: Open Label Selinexor

What is being measured

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

  1. Overall Response Rate

    To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.

    Measured: 24 months

Secondary outcomes (4)

  1. Overall Response Rate

    To determine the overall response rate to according to modified ITMIG response criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 24 months

  2. 6 Month Progression Free Survival Rate

    To determine six months progression free survival of patients with TET treated with selinexor

    Measured: 6 months

  3. 24 Month Overall Survival Rate

    To determine overall survival of patients with TET treated with selinexor

    Measured: 24 months

  4. Adverse Events

    The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

    Measured: 24 months

Timeline

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

  1. First posted20 Jun 2017
  2. Study start3 Apr 2018
  3. Primary completion27 Jul 2020
  4. Study completion31 Jan 2022

Why it stopped: Slow Accrual

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03193437
Sponsor's protocol ID
2016-0622
Acronym
SELECT
Status last verified
Apr 2022
First submitted
19 Jun 2017
Last updated
16 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Open Label Selinexor in people with Thymoma and Advanced Thymic Epithelial Tumor, run by Georgetown University at 2 sites 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 16 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: 24 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 NCT03193437.

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 16 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in