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Soft Tissue SarcomaPhase 1NCT03042819

Study of Selinexor and Doxorubicin in Advanced Soft Tissue Sarcomas

A Phase 1 study testing Selinexor and Doxorubicin in people with Soft Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.

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

This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study is to determine how safe and tolerable the combination is, as well as the best dose of the study drugs in this patient population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Selinexor and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteCanada
Study dates
16 May 2017to 30 Jun 2021
Phase
Phase 1
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
  • Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  • Age ≥ 18 years.
  • Patients must have histologically confirmed locally advanced/unresectable or metastatic soft tissue sarcoma.
  • Patients must have not received prior doxorubicin.
  • Patient must show evidence of progressive disease on study entry or newly diagnosed patients with de novo metastatic measurable disease
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  • Patient must have measureable disease as defined by RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Adequate hematopoietic function
  • Adequate hepatic function:
  • Adequate renal function
  • Adequate cardiac function13
  • Patients must agree to use methods of contraception as a agreed upon by the patient and study doctor

Who cannot join

  • Patient is pregnant or lactating
  • Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy.
  • Major surgery within 4 weeks before initiation of therapy
  • Unstable cardiovascular function
  • Active, ongoing or uncontrolled active infection within one week prior to first dose.
  • Malignancies other than disease under study within 2 years prior to Cycle 1, Day 1.
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  • Known to be HIV seropositive
  • Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B virus (HBV) surface antigen (HBsAg)
  • Patients with active CNS malignancy.
  • Patients with any gastrointestinal dysfunctions that could interfere with the absorption of Selinexor or patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
  • Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents.
  • In the opinion of the Investigator, patients who are significantly below their ideal body weight
  • Serious psychiatric or medical conditions that could interfere with treatment
  • Concurrent therapy with approved or investigational anticancer therapeutic agents
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 1b Trial of Selinexor Plus Doxorubicin in Advanced Soft Tissue Sarcomas (STS)

This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study is to determine how safe and tolerable the combination is, as well as the best dose of the study drugs in this patient population.

Selinexor (also called KPT-330), works by trapping "tumor suppressor proteins" within the cell and thus causing the cancer cells to die or stop growing.

Read the detailed description

This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma.

Patients will be screened for eligibility within 28 days of the start of the study drugs. In addition to standard tests and procedures, research tumor tissue (archival or fresh biopsy) will be collected for collection for pharmacodynamics. Participants will also be asked if they agree to optional biopsies at 6 cycles if their cancer is responding and at disease progression.

Eligible participants will then receive the study drugs in 21 day cycles. Selinexor will be given by mouth and doxorubicin will be given by vein, once a week, for 6 cycles.

Participants will be restaged every 2 cycles. If participants respond to treatment after 6 cycles, they may be able to continue the selinexor alone as a maintenance treatment until progression or unacceptable toxicity.

While receiving the study drug, many of the screening tests will be repeated. Additional tests and procedures include blood sample collection for pharmacokinetics and pharmacodynamics.

When participants stop the study drug permanently for any reason, an end of treatment visit, 28-day follow-up, and long term follow up every 90 days will occur.

Being tested
Selinexor, Doxorubicin
Medical subject headings
Sarcoma

What participants receive

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

  • SelinexorDrug

    Selinexor is a Selective Inhibitor of Nuclear Export (SINE) compound that binds and inactivates Exportin 1 (XPO1), thereby forcing the nuclear retention of key tumor suppressor proteins (TSPs).

  • DoxorubicinDrug

    Doxorubicin is currently approved for various cancers. Doxorubicin inhibits DNA synthesis and repair by inhibiting topoisomerase II and also by intercalation between base pairs on the DNA helix. These actions result in the blockade of DNA and RNA synthesis and fragmentation of DNA.

Study groups in NCT03042819
Study groupRoleWhat they receive
Selinexor plus DoxorubicinExperimentalSelinexor will be given by mouth (orally) once a week: Dose Level -1 = 40 mg Dose Level 1 (Starting Dose) = 60 mg Dose Level 2 = 80 mg Doxorubicin will be given by vein (intravenously) at a dose of 75 mg/m2 once every 3 weeks.
Receives: Drug: Selinexor; Drug: Doxorubicin

What is being measured

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

  1. To evaluate the Incidence of Treatment-Emergent Adverse Events, graded and categorized according to the CTCAE v4.0.

    All adverse events will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. SAE specific incidence and exact 95% confidence interval will be provided where appropriate.

    Measured: 3 years

  2. To determine the recommended phase II dose (RP2D) of Selinexor in combination with doxorubicin

    The RP2D will be determined according to interim mTPI monitoring algorithm (Figure 5.1) using the dose determining set.

    Measured: 3 years

Secondary outcomes (3)

  1. Rate of Grade 3 Toxicities

    Measured: 3 years

  2. Response Rate

    Measured: 3 years

  3. Progression-free Survival Rate

    Measured: 3 years

Timeline

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

  1. First posted3 Feb 2017 (estimated)
  2. Study start16 May 2017
  3. Primary completion30 Nov 2019
  4. Study completion30 Jun 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03042819
Sponsor's protocol ID
SAR-002
Status last verified
Nov 2021
First submitted
1 Feb 2017
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selinexor and Doxorubicin in people with Soft Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.

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 13 inclusion and 15 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 9 Dec 2021. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

To evaluate the Incidence of Treatment-Emergent Adverse Events, graded and categorized according to the CTCAE v4.0. (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT03042819.

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 9 Dec 2021.

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