Phase II/III Trial of CCRT With or Without JP001 for Newly Diagnosed GBM

NCT03008148 | Unknown Phase 2 DMC

• 1 other identifier: JP001-GM-001
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multi-center, phase II/III, open-label, randomized, parallel and standard chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to receive control treatment or study treatment. The primary objective of this trial is to evaluate the effect of add-on JP001 to standard chemoradiation in increasing overall survival (OS) on newly diagnosed glioblastoma (GBM) patients.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall survival time.

  All subjects will be followed until study end (the date of last subject last visit; the last subject need to be followed at least 30 months) or death, whichever comes first; OS defined as the time from the date of Randomization to the date of death or last follow-up.

  120 weeks

Secondary Outcomes (9)

• Progression-free survival time

  120 weeks

• OS rate at 1 year.

  1 year

• PFS rate at 1 year.

  1 year

• The time and rate of OS in different RPA class.

  120 weeks

• The time and rate of PFS in different RPA class.

  120 weeks

Study Arms (2)

Radiation,Temozolomide

ACTIVE COMPARATOR

1. CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks). 2. Rest Phase: Rest for 4 weeks. 3. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles. 4. Maintenance Phase: No maintenance treatment until disease progression confirmed.

Radiation: CCRT; Drug: Temozolomide

Radiation,Temozolomide,Siroquine(JP001)

EXPERIMENTAL

1. CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks) + Daily JP001 (2 tablets once a day for 6 weeks). 2. Rest Phase: Daily JP001(2 tablets/day) for 4 weeks. 3. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle). 4. Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed.

Radiation: CCRT; Drug: Temozolomide; Drug: Siroquine

Interventions

CCRT RADIATION

CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks).

Radiation,Temozolomide; Radiation,Temozolomide,Siroquine(JP001)

Temozolomide DRUG

Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles.

Also known as: Chemotherapy

Radiation,Temozolomide; Radiation,Temozolomide,Siroquine(JP001)

Siroquine DRUG

1. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle). 2. Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed.

Also known as: JP001

Radiation,Temozolomide,Siroquine(JP001)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically proven newly diagnosed case of GBM (WHO grade IV) and treatment-naive (chemotherapy and radiotherapy) for GBM. Diagnosis must be made by stereotactic biopsy or surgical excision, either partial or complete within 3 months prior to Visit 1.
• Subject's RPA class is class III, IV or V.
• Subjects with stereotactic biopsy or brain surgery must be suited for or will be scheduled for CCRT followed by Temozolomide treatment, the standard treatment recommended by institutes and fulfilled the reimbursement guideline of National Health Insurance Administration.
• Subjects must have recovered from the effects of surgery, post-operative infection, and other complications prior to Visit 1. Study treatment must be performed \> 3 weeks and ≤ 8 weeks after craniotomy. Ventricular fluid reservoir or Ventriculo-Peritoneal shunting tube is allowed to keep.
• A diagnostic contrast-enhanced MRI of the brain must be performed postoperatively within 28 days prior to Visit 2 (Day 1).
• ECOG performance status ≤ 3 at Visit 1.
• Age from 20 to 80 years old at Visit 1.
• Life expectation ≥ 12 weeks at Visit 1.
• CBC/differential obtained at Visit 1, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 (1.5 x 109/L) or white blood cell (WBC) ≥ 3,000 cells/mm3 (3 x 109/L).
• Platelets count ≥ 100,000 cells/mm3 (100 x 109/L).
• Hemoglobin (Hgb or Hb) ≥ 10.0 g/dL (100 g/L) (Note: The use of transfusion or other intervention to achieve Hemoglobin ≥ 10.0 g/dL (100 g/L) is acceptable).
• Adequate renal function, as defined below:
• a. Creatinine ≤ 1.5 times upper laboratory limit at Visit 1.
• Adequate hepatic function, as defined below:

You may not qualify if:

• Other invasive malignancy. However, subject with other invasive malignancy that have been disease-free more than or equal to 10 years and deemed no need for anti-cancer treatments can be recruited. Subjects with noninvasive malignancy, including carcinoma in situ of the breast, non-melanomatous skin cancer and cervix carcinoma in situ can be recruited if disease-free and treatment free more than or equal to 3 years.
• Metastases detected beyond the cranial vault.
• Subjects with the following history:
• Brain irradiation or Temozolomide usage.
• Macular degeneration or retinopathy.
• Renal transplantation.
• Subjects are currently receiving any anti-rejection medicine or Hydroxychloroquine sulfate for rheumatoid arthritis.
• Subjects with severe and active co-morbidity, defined as follows:
• Clinical active kidney, liver, lung or cardiac disease.
• Acute bacterial or fungal infection requiring intravenous antibiotics at Visit 1 and acquired immune deficiency syndrome (AIDS).
• Any active infection or uncontrolled infection at Visit 1.
• Abnormal CXR finding with risks of infection and interstitial lung disease/pneumonitis.
• Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant from study drug.
• Mean QTc \> 500 msec (with Bazett's correction), history of familial long QT syndrome or other significant ECG abnormality noted at Visit 1.
• Known hypersensitivity reactions to Temozolomide, dacarbazine (DTIC), hydroxychloroquine, 4-aminoquinoline, rapamune, sirolimus, rapamycin, or their analogs.

Sponsors & Collaborators

• Johnpro Biotech, Inc.: lead

Study Sites (2)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 11490, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide; Drug Therapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Central Study Contacts

Kwan-Hwa Chi

CONTACT

886-2-28332211; M006565@ms.skh.org.tw

Susan Huang

CONTACT

886-2-28332211; susan.huang@johnpro.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: January 2, 2017
• Study Start: October 11, 2018
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)