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Non Hematologic CancersPhase 1NCT01991938

Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma

A Phase 1 study testing VS-5584 in people with Non Hematologic Cancers and Metastatic Cancer, run by Verastem, Inc. at 5 sites in 2 countries.

Terminated

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

Official record
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Trial summary

This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VS-5584
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
5 sitesin 2 countries
Study dates
Nov 2013to Dec 2016
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

  • Able to provide signed and dated informed consent prior to initiation of any study procedures.
  • Age ≥ 18 years.
  • Subjects must have a histopathologically confirmed diagnosis of an advanced non-hematologic malignancy or lymphoma or indolent NHL/CLL.
  • Subjects must have no alternate therapy of proven benefit or have refused standard therapy.
  • All clinically significant toxicities from prior chemotherapy must be ≤ Grade 1.
  • ECOG performance status of 0 or 1, measured at screening and immediately before the start of treatment.
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  • Predicted life expectancy of ≥ 3 months.
  • Fasting blood glucose of ≤ 140 mg/dL (7.8 mmol/L).
  • Adequate renal function [creatinine ≤ 1.5x ULN (upper limit of normal)] or GFR of ≥ 60mL/min.
  • Adequate hepatic function (total bilirubin ≤ 1.5x ULN for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] ≤ 3x ULN).
  • Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; platelets ≥ 75 x10^9 cells/L; absolute neutrophil count ≥ 1.0x10^9 cells/L).
  • Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction formula).
  • Negative pregnancy test for women of child-bearing potential.
  • Men and women of child bearing potential must agree to use adequate birth control throughout their participation in the study and for 60 days following the last study treatment.
  • Willing and able to participate in the trial and comply with all trial requirements.
  • Subjects must have archival tumor tissue available for mutational analysis. A study specific biopsy can be performed if archival tissue is not available.
  • Stable brain metastases either treated or being treated with a stable dose of steroids/ anticonvulsants, with no dose change within 28 days prior to the first dose of study drug, will be allowed.

Who cannot join

  • Gastrointestinal (GI) condition which could interfere with the swallowing or absorption of study medication.
  • Uncontrolled or severe concurrent medical condition including cardiovascular disease (e.g., myocardial infarct, unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, cardiac amyloidosis, transient ischemic attacks, CVA, coronary artery or other vascular stents).
  • A past history of, or current uncontrolled hypertension. Blood pressure must be adequately controlled prior to dosing with VS-5584.
  • Prior history of a hypertensive reaction to a kinase inhibitor
  • History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug.
  • Subjects with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required).
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  • Subjects with known active Hepatitis A, B or C (testing not required).
  • Subjects being actively treated for a secondary malignancy.
  • Cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy with the exception of LHRH agonists for prostate cancer, biologic or immunotherapy, etc.) within 21 days of the first dose of study drug or 5 half-lives, whichever is shorter. Palliative radiotherapy is allowed prior to initiating treatment if associated toxicity resolved to ≤ Grade 1.
  • Subjects currently taking medications known to be strong CYP3A4 inhibitors.
  • Major surgery within 28 days prior to the first dose of study drug.
  • Subjects with acute or chronic pancreatitis.
  • Subjects with diabetes mellitus requiring insulin treatment or subjects with a HbA1C > 7.
  • Use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug. A minimum of 14 days between termination of the investigational drug and administration of the study treatment is required. In addition, any drug-related toxicity except alopecia should have recovered to grade 1 or less.
  • Women who are pregnant or breastfeeding.
  • Any evidence of serious active infections.
  • Uncontrolled intercurrent illness involving any other organ system or a social situation that would, in investigator's opinion, place the subject at unacceptable risk, limit compliance, or confound interpretation of safety or other results.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

United Kingdom1 site

  • The Royal Marsden

    Sutton, London, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase I Dose Escalation Study of VS-5584, a Dual PI3K/mTOR Inhibitor, in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma

This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor biopsies (in consenting subjects), and blood samples.

Being tested
VS-5584
Keywords
PI3K Inhibitor, mTOR Inhibitor, Dual PI3K/mTOR Inhibitor, CSC, Cancer Stem Cells
Medical subject headings
Neoplasm Metastasis, Lymphoma

What participants receive

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

  • VS-5584Drug

Study groups in NCT01991938
Study groupRoleWhat they receive
VS-5584ExperimentalOral VS-5584 administered once daily on Day 1, 3, 5, 8, 10, 12, 15, 17 and 19 of each cycle
Receives: Drug: VS-5584

What is being measured

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

  1. Assess the safety and tolerability of VS-5584 in subjects with advanced non-hematologic malignancies or lymphoma

    Serious Adverse events, Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECGs as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) V4.03. A Safety Monitoring Committee will review safety information.

    Measured: From start of treatment to end of treatment, an expected average of 6 weeks

  2. Determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) and schedule of VS-5584 administered to subjects with advanced non-hematologic malignancies or lymphoma

    The RP2D will be determined based on the MTD of VS-5584 as determined by number of participants with dose limiting toxicities related to VS-5584. Observations related to pharmacokinetics, pharmacodynamics, and any VS-5584 related toxicities may be included in the rationale supporting the RP2D and schedule and will not exceed the MTD.

    Measured: From start of treatment to end of Cycle 1 (21 day cycles)

Secondary outcomes (1)

  1. Assess the pharmacokinetics of VS-5584

    PK (pharmacokinetics) parameters, including but not limited to plasma concentration, clearance, AUC (Area Under Curve, 0-24 and 0-t), Cmax, Tmax, and T1/2

    Measured: Time points on Day 1, 2, 3, 17, 18

Timeline

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

  1. First posted25 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Why it stopped: Lack of recruitment and the company's decision to de-prioritize 5584 development

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01991938
Sponsor's protocol ID
VS-5584-101
Status last verified
Jan 2016
First submitted
18 Nov 2013
Last updated
27 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VS-5584 in people with Non Hematologic Cancers and Metastatic Cancer, run by Verastem, Inc. at 5 sites in 2 countries.

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 17 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: stopped early, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, United Kingdom. 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 was stopped early (reason given: Lack of recruitment and the company's decision to de-prioritize 5584 development). Results are not available in the source record.

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?

Assess the safety and tolerability of VS-5584 in subjects with advanced non-hematologic malignancies or lymphoma (time frame: From start of treatment to end of treatment, an expected average of 6 weeks). 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 NCT01991938.

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 27 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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