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NeoplasmsPhase 1NCT03416816

A Study of DSP-0337 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile

A Phase 1 study testing DSP-0337 in people with Neoplasms, run by Sumitomo Pharma America, Inc. at 4 sites in United States.

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 1, open label, multi-center study of orally administered DSP-0337 in adult subjects with advance solid tumors that are refractory to standard treatment, or for whom no effective therapy exists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
DSP-0337
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
4 sitesUnited States
Study dates
15 May 2018to 15 Jun 2020
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

  • Histologically or cytologically confirmed diagnosis of advanced cancer in patients with solid tumors that are refractory to standard treatment, or for whom no effective therapy exists.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Patients must be at least 18 years of age.
  • Organ function must be adequate as follows:
  • Bone Marrow Reserve: absolute neutrophil count ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; hemoglobin ≥ 9.0 g/dL. Must not have required blood transfusion within 1 week of baseline blood count assessment.
  • Hepatic: bilirubin < 1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) < 3.0 x ULN (AP, AST, and ALT < 5 x ULN is acceptable if the liver has tumor involvement).
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  • Renal: serum creatinine within normal limits; for patients with levels above the institutional normal value, the calculated corrected creatinine clearance must be ≥ 60 mL/min/1.73 m^2 using the Cockcroft-Gault formula corrected for the body surface area.
  • Toxicities incurred as a result of previous anti cancer therapy (radiation therapy [RT], chemotherapy, or surgery) must be resolved to ≤ Grade 1 except for alopecia and anorexia.
  • Patients must provide written informed consent.
  • Female patients are eligible for the study if they meet the following criteria:
  • Are not pregnant or nursing;
  • Of non-childbearing potential defined as women who have had a hysterectomy, bilateral oophorectomy, medically documented ovarian failure, or are documented postmenopausal (follicle stimulating hormone > 40 mIU/mL); OR,
  • Of childbearing potential defined as including women < 55 years of age, even those who have experienced 2 years of amenorrhea; all women should also meet both of the following criteria:
  • A negative serum or urine pregnancy test during Screening,
  • Sexually abstinent or correct and consistent use of one of the following methods of birth control in addition to a male partner using a condom from Screening to 3 months after the last dose of study drug:
  • hormone-containing contraceptive intrauterine device with a failure rate of < 1% per year,
  • cervical cap or diaphragm with a spermicidal agent,
  • tubal sterilization, or
  • vasectomy in male partner. Male patients must agree to sexual abstinence or to consistently and correctly use a condom in combination with one of the above methods of birth control from Screening to 3 months after the last dose of study drug.
  • Life expectancy must be ≥ 3 months.

Who cannot join

  • Has received systemic anti-cancer therapy within the 3 weeks prior to starting the trial.
  • Has received radiotherapy within the 28 days prior to first dose or within 12 weeks for patients with glioblastoma, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control.
  • Has received major surgery within the 4 weeks prior to starting the trial.
  • Has significant inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
  • Clinically active known brain metastasis unless the brain metastases have been previously treated and are considered stable. Stable brain metastases are defined as no change on computed tomography (CT) scan or magnetic resonance imaging (MRI) for a minimum of 2 months and no change in steroid dose for a minimum of 4 weeks prior to starting the trial.
  • Is pregnant or lactating.
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  • Had prior malignancy other than carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 3 years previously with no subsequent evidence of recurrence. If the patient has a medical history of a previous tumor that is not included in this criteria and that the Investigator feels is irrelevant for the objectives of the study, it should be evaluated with the Sponsor or Medical Monitor.
  • Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant.
  • Has a known clinically significant GI disorder(s) including, but not limited to, inflammatory bowel disease or a history of extensive gastric resection and/or small intestinal resection.
  • Has inability to take oral medications and/or has clinical or radiological diagnosis of bowel obstruction.
  • Had prior treatment with napabucasin (BBI-608).
  • Is not able to avoid the concomitant use of proton pump inhibitors (PPIs) or histamine H2-receptors antagonists, which have long-lasting pH-elevating effects, during DSP-0337 dosing, or avoid the use of antacids until at least 2 hours after dosing.
  • Has a known history of human immunodeficiency virus (HIV) infection, active hepatitis B, or untreated hepatitis C; patients who have completed a course of antiviral treatment for hepatitis C are eligible.
  • Has inability to comply with the protocol or study procedures.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Karmos Cancer Center

    Detroit, Michigan, 48201

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • UT Heatlh San Antonio

    San Antonio, Texas, 78229

  • Utah Cancer Specialist

    West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid Tumors

This is a Phase 1, open label, multi-center study of orally administered DSP-0337 in adult subjects with advance solid tumors that are refractory to standard treatment, or for whom no effective therapy exists.

Read the detailed description

The study is comprised of two parts: an initial dose escalation phase utilizing a 3 + 3 design to determine maximum tolerated dose followed by a dose expansion cohort in approximately 30 additional subjects. Study participants will initially receive DSP-0337 orally for 28 days (one cycle of treatment). If clinical benefit is seen, treatment can continue until disease progression.

Conditions
Neoplasms
Being tested
DSP-0337
Keywords
DSP-0337
Medical subject headings
Neoplasms

What participants receive

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

  • DSP-0337Drug

    DSP-0337 will be administered at the following doses in dose-escalation cohorts, maximum tolerated dose (MTD) for food effect, and recommended phase 2 dose (RP2D) for dose-expansion cohort. Dose 1: 200 mg once daily, Dose 2: 200 mg twice daily, Dose 3: 400 mg twice daily, Dose 4: 600 mg twice daily, Dose 5: 800 mg twice daily, Dose 6: 1000 mg twice daily.

Study groups in NCT03416816
Study groupRoleWhat they receive
DSP-0337ExperimentalIn Part 1 - Up to six dose levels will be investigated in dose-escalating cohorts to identify a maximum tolerated dose (MTD). An additional subset of patients will be treated to assess the effect of food intake on the PK of DSP-0337 administration at the MTD level. Once the recommended Phase 2 dose (RP2D) has been established, patients will be treated with the RP2D to explore preliminary antitumor activity and safety profile.
Receives: Drug: DSP-0337

What is being measured

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

  1. Maximum tolerated dose by assessing dose-limiting toxicities (DLTs)

    Dose escalating cohort

    Measured: 4 weeks

  2. Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)

    Dose escalating cohort

    Measured: 4 weeks

Secondary outcomes (6)

  1. Number of Patients with Adverse Events

    Tolerability will be evaluated based on the adverse events (AEs) recorded at each contact with the patient, physical examinations, and the results of laboratory tests. Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

    Measured: 12 months

  2. Pharmacokinetics by assessing drug concentration in blood

    For food effect, dose escalating cohort

    Measured: 4 weeks

  3. Urine excretion of napabucasin after DSP-0337 administration

    Twenty four-hour urine will be collected and excretion of napabucasin will be evaluated.

    Measured: 24 hours

  4. Objective response rate (ORR)

    Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1.

    Measured: 6 months

  5. Time to progression (TTP)

    Defined as the time from first dose to the earlier date of assessment of progression by RECIST v1.1.

    Measured: 6 months

  6. Progression free survival (PFS)

    Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v1.1.

    Measured: 12 months

Timeline

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

  1. First posted31 Jan 2018
  2. Study start15 May 2018
  3. Primary completion15 Jun 2020
  4. Study completion15 Jun 2020

Why it stopped: Alternate development strategy

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03416816
Sponsor's protocol ID
BBI-DSP0337-101
Status last verified
Nov 2023
First submitted
18 Jan 2018
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DSP-0337 in people with Neoplasms, run by Sumitomo Pharma America, Inc. at 4 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 20 inclusion and 14 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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: Alternate development strategy). 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?

Maximum tolerated dose by assessing dose-limiting toxicities (DLTs) (time frame: 4 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 NCT03416816.

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 14 Nov 2023.

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