Selinexor Combination Ph 1 Study

December 14, 2021 updated by: Martin Gutierrez

An Investigator Sponsored Phase I/II Study of Selinexor in Combination With Irinotecan in Adults With Solid Tumors

The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of selinexor (KPT-330) in combination with Irinotecan in patients with solid tumors. A secondary purpose is to evaluate the pharmacokinetics (PK) of selinexor with irinotecan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at HackensackUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have histologically confirmed solid tumor malignancy that is metastatic or unresectable for which standard curative measures do not exist, or are associated with minimal patient survival benefit, and for whom irinotecan therapy may be appropriate.
  • Any prior therapy must have been completed > 2 weeks prior to enrollment on the protocol in patients participating and must have recovered to eligibility levels (CTCAE grade </= 1) from prior toxicity. Prior radiation or surgery should have been completed > 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels.
  • Age >/= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of selinexor in patients < 18 years of age, children are excluded from this study, but may be eligible for future pediatric Phase 1 combination trials.
  • Eastern Cooperative Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
  • Life expectancy >/= 3 months.
  • Patients must have normal organ and marrow function as defined below:
  • Absolute Neutrophil count >/= 1,500u/L
  • Platelets >/= 125,000u/L
  • Total Bilirubin </= 1.5x institution upper limit of normal
  • AST (SGOT)/ALT(SGPT) </= 2.5x institutional upper limit of normal, if liver metastasis </= 5x institutional upper limit.
  • Creatinine </= 1.5x institutional upper limit of normal. or
  • Creatinine clearance >/= 50mL/minute for patients with creatininelevels > 1.5x institutional upper limit of normal.
  • The effects of selinexor on the developing human fetus are unknown. For this reason, and because Irinotecan used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after completion of study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients who have previously

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or those who have not recovered from AEs due to agents administered more than 2 weeks earlier. Patients must be >/= 2 weeks since any investigational agent was administered as part of an exploratory IND study and should have recovered to eligibility levels from any toxicity.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, prolonged QTc interval (>500 msec), or psychiatric illness/social situations that would limit compliance with study requirements.
  • In the Food and Drug Administration (FDA) Use-in-Pregnancy Ratings for Drugs, Irinotecan is classified as category D drugs, indicating that investigational or postmarketing data show risk to the fetus. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after completion of study. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately. Because there is a risk for AEs in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued while the patient is on this trial and for 30 days after completion of treatment on this trial.
  • Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status is stable with or without treatment without steroids (except for maintenance replacement doses of steroids).
  • Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies or confirmed diagnosis of HIV infection, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are excluded from this trial.
  • Grade >/= 3 toxicity related to irinotecan for patients who have received prior irinotecan.
  • Both men and women of all races and ethnic groups are eligible for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Level -1
Selinexor 12mg po twice weekly (Monday & Wednesday or Tuesday & Thursday); Irinotecan 50mg/m2 IV once daily on days 1, 8 & 15
Drug: Irinotecan
Other Names:
  • Camptosar
Drug: Selinexor
Other Names:
  • KPT-330
Experimental: Dose Level 1
Selinexor 15mg po twice weekly (Monday & Wednesday or Tuesday and Thursday); Irinotecan 75mg/m2 IV once daily on days 1, 8 & 15.
Drug: Irinotecan
Other Names:
  • Camptosar
Drug: Selinexor
Other Names:
  • KPT-330
Experimental: Dose Level 2
Selinexor 20mg po twice weekly (Monday & Wednesday or Tuesday and Thursday); Irinotecan 100mg/m2 IV once daily on days 1, 8 & 15.
Drug: Irinotecan
Other Names:
  • Camptosar
Drug: Selinexor
Other Names:
  • KPT-330
Experimental: Dose Level 3
Selinexor 30mg po twice weekly (Monday & Wednesday or Tuesday and Thursday); Irinotecan 75mg/m2 IV once daily on days 1, 8 & 15.
Drug: Irinotecan
Other Names:
  • Camptosar
Drug: Selinexor
Other Names:
  • KPT-330
Experimental: Dose Level 4
Selinexor 30mg po twice weekly (Monday & Wednesday or Tuesday and Thursday); Irinotecan 125mg/m2 IV once daily on days 1, 8 & 15.
Drug: Irinotecan
Other Names:
  • Camptosar
Drug: Selinexor
Other Names:
  • KPT-330

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03
Time Frame: From date of first dose through study completion, an average of 1 year
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03
From date of first dose through study completion, an average of 1 year
Establish the maximum tolerated dose (MTD) for the combination of selinexor with Irinotecan.
Time Frame: From date of first dose through study completion, an average of 1 year
Establish the maximum tolerated dose (MTD) for the combination of selinexor with Irinotecan.
From date of first dose through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Martin Gutierrez

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hackensack Meridian Health
Karyopharm Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IST: PRO5126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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