臨床研究等提出・公開システム

Phase I/II Clinical Study of OP-10 for Recurrent or Exacerbated Glioma

OP-10-001 Study

Taguchi Fumi

Ohara Pharmaceutical Co., Ltd.

36F St.Luke's Tower, 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591, Japan

chiken@ohara-ch.co.jp

Ohara Pharmaceutical Co., Ltd.

36F St.Luke's Tower, 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591, Japan

+81-3-6740-7701

chiken@ohara-ch.co.jp

completed

Mar. 11, 2020

Interventional

Multicenter, single-arm, open-label, phase I/II study with central enrollment system

treatment purpose

1-2

Patients who meet all of the following criteria will be selected.
(1) Phase I: Recurrent or exacerbated glioma that is refractory to standard therapy or for which there is no standard therapy, has been diagnosed.
Phase II: Recurrent or exacerbated diffuse midline glioma has been diagnosed.
(2) Phase I: Age at the time of enrollment is 17 years or older.
(3) The body weight allows administration of OP-10 at the dose level of OP-10 at the time of enrollment.
(4) Have a history of standard treatment.
(5) Lesions in the brain have been confirmed by MRI examination.
(6) Phase I: Performance status (Karnofsky scale) is 80% or higher.
Phase II: Performance status (Karnofsky scale) is 50% or higher (excluding patients with performance status of 30-40% due to underlying disease).
(7) At least 14 days have passed since the last dose of the most recent antineoplastic drug therapy. However, at least 30 days have passed since the last dose of bevacizumab.
(8) Phase I: At least 14 days have passed since the last irradiation in the most recent radiotherapy.
Phase II: At least 90 days have passed since the last irradiation in the most recent radiotherapy.
(9) Capsules can be taken orally.
(10) RANO-LGG criteria can be used for evaluation.
(11) Steroid dose have been stable or decreasing for at least 3 days prior to MRI at enrollment.
(12) Have the following organ functions.
[1] Neutrophil count: 1000/uL or more
[2] Platelet count: 10x10^4/uL or more
[3] Serum creatinine: not over the upper limit of facility standard value
[4] Total bilirubin: not more than 1.5 times the upper limit of facility standard value
[5] ALT: 110 IU/L or less
[6] Serum albumin: 2.5 g/dL or more
[7] Hemoglobin: 8.0 g/dL or more
(13) If a patient or partner is of childbearing potential, they can agree to use contraception before the start of the trial, during the protocol treatment, and for 180 days after the last administration of OP-10.
(14) Written informed consent to participate in the trial can be obtained from the subject (for subject is 20 years of age or older) or the subject's legally authorized representative (for subject is younger than 20 years of age).

Patients who meet any of the following criteria will be excluded.
(1) Patient who have received prior treatment with OP-10.
(2) A history of hypersensitivity to any of the ingredients of OP-10.
(3) A concurrent infection.
(4) Positive HBs antigen blood virological test result at enrollment
However, even if the HBs antigen result is negative, patients who are HBc and/or HBs antibody-positive will be excluded (excluding a history of HB vaccination).
(5) Positive HCV antibody blood virological test result at enrollment
(6) Positive HIV antibody blood virological test result at enrollment
(7) A history of cardiac disease (excluding cured congenital diseases).
(8) A history of interstitial lung disease
(9) Participation in the trial is judged to be difficult due to a concurrent psychiatric disease.
(10) Ingestion of drugs, foods or beverages that inhibit CYP3A within 72 hours before administration of OP-10 and during the protocol treatment.
(11) Ingestion of drugs, foods or beverages that induce CYP3A within 2 weeks before the start of the trial and during the protocol treatment.
(12) Participants in another clinical trial
(13) Breastfeeding women (patients who are presently breastfeeding will be excluded, even if they suspend breastfeeding.)
(14) Women who are pregnant or suspected of being pregnant
(15) Patient who is ineligible for the trial, judged by the investigator or subinvestigator.

Both

Phase I:recurrent or exacerbated gliomas
Phase II:recurrent or exacerbated diffuse midline gliomas

investigational material(s)
Generic name etc : OP-10
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : OP-10 will be administered orally 2 hours before or 2 hours after a meal once a week for 3 weeks (Day 1, Day 8 +/-1, and Day 15+/-1). This 3-week cycle will be regarded as one course, and will be performed until Course 8 (Week 24). However, administration may be continued to Course 36 (Week 108) from ethical considerations. In phase I, 125, 250, 375, 500, or 625 mg OP-10 will be administered based on body weight catalog of OP-10 dose level specified by the case registration center. In Phase II, dosing is based on the recommended dose level determined in Phase I.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
efficacy
Phase I: Incidence of DLT in Course 1
Phase II: Response rate based on the best overall response(ORR)

safety
efficacy
pharmacokinetics
Phase I: ORR, disease control rate(DCR), clinical benefit rate(CBR), overall survival from Day 1 of the first course(OS), survival rate at 6 months after Day 1 of the first course(OS-6), progression-free survival from Day 1 of the first course(PFS), progression-free survival rate at 6 months after Day 1 of the first course(PFS-6), neurological tests, dose of steroids, adverse events, adverse drug reactions and plasma OP-10 concentration.
Phase II: DCR, CBR, OS, OS-6, PFS, PFS-6, neurological tests, dose of steroids, adverse events, adverse drug reactions and plasma OP-10 concentration.

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Feb. 26, 2020

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