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Study of DSP-0390 in Patients With Recurrent High-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05023551
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharma Oncology, Inc.

Brief Summary:
This is a study of DSP-0390 in patients with recurrent high grade glioma.

Condition or disease Intervention/treatment Phase
High Grade Glioma Glioblastoma Multiforme Drug: DSP-0390 Early Phase 1

Detailed Description:
This study will evaluate the safety and efficacy of DSP-0390 in patients with recurrent high grade glioma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a Phase 1 dose-escalation study with a Part 2 expansion to evaluate the safety, PK, PD, and preliminary antitumor activity of orally administered DSP 0390 in patients with recurrent high-grade glioma. Patients in this study will receive DSP-0390 orally once daily. The study will be divided into 28-day cycles for safety and response assessments. Patients will continue treatment until progression of disease, unacceptable toxicity, withdrawal of consent, loss to follow-up, or discontinuation of the patient by the investigator.

Dose-escalation will evaluate increasing dose levels of DSP-0390 to determine the MTD and/or a suitable lower dose for expansion (the RDE) in patients with recurrent WHO Grade III or IV malignant glioma. Once the MTD and/or RDE has been established, the dose escalation (Part 2) will evaluate preliminary clinical activity and the safety and tolerability of DSP-0390 in patients with recurrent WHO Grade 4 glioblastoma multiforme (GBM).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
Actual Study Start Date : September 8, 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm DSP-0390
Arm Description [*] DSP-0390 by oral administration
Drug: DSP-0390
DSP-0390 administered orally




Primary Outcome Measures :
  1. Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma [ Time Frame: From date of treatment through 30 days after End of Treatment an average of 6 months ]
    Occurrence of DLTs by Incidence of TEAEs and SAEs, as assessed by NCI CTCAE v5.0

  2. Dose Escalation: Assess safety of DSP-0390 by severity of TEAEs and SAEs in adult patients with recurrent high-grade glioma [ Time Frame: From date of treatment through 30 days after End of Treatment an average of 6 months ]
    Occurrence of DLTs by severity of TEAEs and SAEs, as assessed by NCI CTCAE v5.0

  3. Dose Escalation: Determine the MTD and/or RDE of DSP-0390 [ Time Frame: From date of first treatment through Cycle 1 (28-day cycle) DLT monitoring period ]
    Incidence of dose-limiting toxicities

  4. Dose Expansion: Evaluate the change in Baseline tumor activity of DSP-0390 using radiologic assessments. [ Time Frame: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months ]
    Evaluate the change in baseline tumor activity of DSP-0390 using radiologic assessments evaluated by RANO 2010 Evaluation Criteria

  5. Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs [ Time Frame: From date of first treatment through study completion, an average of 6 months ]
    Assess the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs

  6. Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose by assessment of severity of TEAEs and SAEs [ Time Frame: From date of first treatment through study completion, an average of 6 months ]
    Assess the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of severity of TEAEs and SAEs


Secondary Outcome Measures :
  1. Dose Escalation: Characterize the PK profile for AUC [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs, each cycle is 28 days ]
    PK assessed for AUC

  2. Dose Escalation: Characterize the PK profile for Cmax [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 -0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days ]
    PK assessed for Cmax

  3. Dose Escalation: Characterize the PK profile for tmax [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days ]
    PK assessed for tmax

  4. Dose Escalation: Characterize the PK profile for t1/2 [ Time Frame: From date of first treatment, Cycle 1 Day 1 and Cycle 2 Day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days] ]
    PK assessed for t1/2

  5. Dose Escalation: Characterize the PK profile for Racc [ Time Frame: Cycle 1 Day 8, 15 and 22 and Cycle 2 Day 1, each cycle is 28 days ]
    PK assessed for Racc

  6. Dose Escalation: Evaluate preliminary antitumor activity [ Time Frame: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months] ]
    Objective response (complete or partial response) and duration of response assessed by RANO criteria.


Other Outcome Measures:
  1. Exploratory: Assess the PD effect of DSP-0390 [ Time Frame: From first date of treatment, blood tests performed at 8 week intervals through study completion, an average of 6 months ]
    Biomarker (lathosterol/zymostenol ratio) in blood



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Estimated life expectancy >+3 months Recovery from toxic effects of prior therapy to NCI CTCAE v5.0 Grade 1 (non-hematologic toxicities) or Grade <=2(hematologic toxicities, except deep vein thrombosis) KPS >=70%

Adequate organ function as determined by:

  • Absolute Neutrophil ≥1500/microliter (may not use G-CSF or GM CSF)
  • Platelet ≥100 × 103/microliter
  • Hemoglobin ≥9 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level)
  • Creatinine Clearance ≥ 40ml/min (Cockcroft-Gault)
  • Total bilirubin ≤1.5 times ULN (or ≤ 2 times ULN for patients with known Gilbert's syndrome)
  • AST ≤ 3 times ULN
  • ALT ≤ 3 times ULN
  • INR, PT, PTT, or aPTT ≤1.5 x ULN Note: The use of anticoagulants is permitted as long as the PT/(a)PTT is within therapeutic limits (according to the local institution standard) and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to study Day 1.

If on antiepileptic drug; dose must be stable and no seizures 14 days prior to study Day 1 If on corticosteroids at baseline, dose must be stable or decreasing for at least 5 days prior to study Day 1. For the dose expansion part of the study, the dose must be ≤ 4 mg dexamethasone per day (or equivalent dose if other corticosteroids are used). A higher stable dose of corticosteroids, if used as HRT, may be allowed upon discussion with the Medical Monitor.

Females of childbearing potential must have a negative serum or urine pregnancy test Male or female patients of child-producing potential must agree to use contraception or use prevention of pregnancy measures or agreement to refrain completely from heterosexual intercourse during the study and for 6 months (females & males) after the last dose of study drug

Exclusion Criteria:

Prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to study Day 1, Multifocal disease, leptomeningeal metastasis, or extracranial metastasis Abnormal ECGs that are clinically significant, including those where QT prolongation (QTcF>450 msec for males and >470 msec for females); and/or history of Torsade de Pointes Left ventricular ejection fraction <40% as determined by ECHO or MUGA Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally Know active Chrohn's or other inflammatory bowel disease History of another primary cancer within the 2 years prior to study Day 1, except for the following: nonmelamona skin cancer, cervical carcinoma in situ, superficial bladder cancer that has been removed or curatively treated.

A known active acute or chronic infection including, but not limited to, HIV, HBV, and HCV [Patients who have completed a course of anti-viral treatment for HVC are eligible provided than an HCV polymerase chain reaction shows no detectable virus] Pregnant or breastfeeding. [Note: Female breastfeeding patients may be enrolled if they interrupt breastfeeding. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug.

The presence of any active retinal abnormality determined by screening tests using visual acuity, visual field, fundoscopy, and OCT Significant cardiovascular disease, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, poorly controlled cardiac arrhythmias, or stroke in the preceding 6 months prior to study Day 1 Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state Major surgical procedure, surgical resection, open biopsy, or significant traumatic injury within 4 weeks prior to study Day 1 or anticipation of need for major surgical procedure during the course of the study Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study Day 1 Evidence of CNS hemorrhage on baseline MRI or CT scan (except for postsurgical, asymptomatic, Gr 1 hemorrhage that has been stable at least 4 weeks for enrolled patients) Chemotherapy or investigational anticancer therapy administered within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to study Day 1 Radiotherapy within 12 weeks prior to study Day 1, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are 2 MRIs (performed 8 weeks apart) confirming progressive disease Concurrent use of prohibited medications: methylprednisolone, prednisone, carbamazepine, phenytoin, phenobarbital, and other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study Day 1 Concurrent treatment with Tumor Treatment Field (Optune) is not allowed. Patients must stop Optune 1 day prior to the first dose of study drug. Any wounds from Optune must be healed adequately prior to study Day 1

History of, within 6 months of study Day 1:

  1. Pneumonitis or interstitial lung disease
  2. Any other lung condition that in the investigators' judgement may put the patient at an increased risk for lung toxicity (including, but not limited to, suspected interstitial lung disease or radiation-induced lung injury)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023551


Contacts
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Contact: Reyna G Bishop, MS, MD 512-363-8755 reyna.bishop@oncology.sumitomo-pharma.com
Contact: Kathleen Hanlon, MBA 617-674-8587 kathleen.hanlon@oncology.sumitomo-pharma.com

Locations
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United States, California
University of California at San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Stephanie Lewis    415-353-2193    stephanie.lewis@ucsf.edu   
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kristina J Williams    314-362-6963    kjw1@wustl.edu   
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lori Cappello, APN    551-996-5098    Lori.Cappello@hmhn.org   
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Cancer Center Clinical Trials Navigator    212-342-5162    cancerclinicaltrials@cumc.columbia.edu   
United States, Utah
Huntsman Cancer Institute, University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Rachel Kingsford    801-585-0115    Rachel.Kingsford@hci.utah.edu   
Japan
Kyoto University Hospital Recruiting
Kyoto, Sakyo-ku, Japan, 606-8507
Contact: Yoshiki Arakawa    075-751-3111    yarakawa@kuhp.kyoto-u.ac.jp   
National Cancer Center Hospital Recruiting
Chuo Ku, Tokyo, Japan, 104-0045
Contact: Yoshitaka Narita    03-3542-2511    yonarita@ncc.go.jp   
Sponsors and Collaborators
Sumitomo Pharma Oncology, Inc.
Investigators
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Study Director: Philip Komarnitsky Sumitomo Pharma Oncology, Inc.
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Responsible Party: Sumitomo Pharma Oncology, Inc.
ClinicalTrials.gov Identifier: NCT05023551    
Other Study ID Numbers: DSP-0390-101
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sumitomo Pharma Oncology, Inc.:
High grade glioma
Glioblastoma Multiforme (GMB)
Brain Tumor
Emopamil binding protein
3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue