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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05009992


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05009992
Ethics application status
Date submitted
10/08/2021
Date registered
18/08/2021

Titles & IDs
Public title
Combination Therapy for the Treatment of Diffuse Midline Gliomas
Scientific title
A Combination Therapy Trial Using an Adaptive Platform Design for Children and Young Adults With Diffuse Midline Gliomas (DMGs) Including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression
Secondary ID [1] 0 0
NCI-2021-08386
Secondary ID [2] 0 0
200821
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Intrinsic Pontine Glioma 0 0
Diffuse Midline Glioma, H3 K27M-Mutant 0 0
Recurrent Diffuse Intrinsic Pontine Glioma 0 0
Recurrent Diffuse Midline Glioma, H3 K27M-Mutant 0 0
Recurrent WHO Grade III Glioma 0 0
WHO Grade III Glioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ONC201
Treatment: Other - Radiation Therapy
Treatment: Drugs - Paxalisib

Experimental: NOT CURRENTLY ENROLLING - ARM 2: ONC201 (Day -1), Radiation+ONC201, Paxalisib+ONC201 - Participants may receive a safety lead in of ONC201. During the trial validation phase, participants without prior biopsy receive ONC201 PO on day -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, participants without prior radiation therapy or have disease progression after radiation therapy undergo weekly radiation therapy and receive ONC201 PO weekly during radiation therapy. During the maintenance phase, participants receive ONC201 PO weekly and paxalisib PO daily (QD). Cycles repeat every 28 days (4 weeks) in the absence of adverse events of unacceptable toxicity

Experimental: NOT CURRENTLY ENROLLING - ARM 4: ONC201 (Day -1,-2), Radiation+ONC201, Paxalisib+ONC201 - Participants may receive a safety lead in of ONC201. During the trial validation phase, participants without prior biopsy receive ONC201 PO on days -2 and -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, participants may receive ONC201 PO weekly during radiation therapy. During the maintenance phase, participants receive ONC201 PO weekly and paxalisib PO QD. Cycles repeat every 28 days (4 weeks) in the absence of adverse events or unacceptable toxicity

Experimental: NOT CURRENTLY ENROLLING - ARM 6: Paxalisib (Day -1), Radiation+Paxalisib , Paxalisib+ONC201 - Participants may receive a safety lead in of ONC201. During trial validation phase, participants without prior biopsy receive paxalisib PO on day -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, participants without prior radiation therapy or have disease progression after radiation therapy undergo weekly radiation therapy and receive paxalisib PO daily during radiation therapy. During the maintenance phase, participants receive ONC201 PO weekly and paxalisib PO QD. Cycles repeat every 28 days (4 weeks) in the absence of adverse events of unacceptable toxicity

Experimental: Cohort 4 - Dose Escalation, Starting Dose 2 (625mg ONC201) - Participants will receive a safety lead in of 625mg ONC201. During the trial validation phase, participants without prior biopsy receive ONC201 PO on days -2 and -1 prior to standard of care biopsy. During any non-interventional radiation/re-irradiation per standard of care treatment, participants will receive 625 mg as the starting dose of ONC201 Days 1 and 2 on a weekly basis. Cycles repeat every 28 days (4 weeks) in the absence of adverse events or unacceptable toxicity

Experimental: Cohort 5 - ONC201 + Targeted therapies - Participants will receive a starting dose of 625mg of ONC201 weekly on Day 1 and 2 during any non-interventional radiation/re-irradiation per standard of care treatment, and in combination with targeted agents to be selected from approved/available agents based on a rational therapy approach guided by molecular data from the tumor tissue or cerebral spinal fluid (CSF). Each individual targeted agent will be dosed at the recommended therapeutic dose, if a dose has been issued for the participant's age group. Observations and schedule of events will be issued based on the chosen agent determined to best fit the molecular profile (e.g. BRAFV600E, PDGFRA, FGFR1, NF1).


Treatment: Drugs: ONC201
Given orally (PO)

Treatment: Other: Radiation Therapy
Undergo radiation therapy

Treatment: Drugs: Paxalisib
Given PO
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival at 6 months (PFS6) - Cohorts 1A, 1B Only
Timepoint [1] 0 0
6 months after administration of ONC201 in the maintenance phase
Primary outcome [2] 0 0
Progression-free survival at 6 months (PFS6) - Cohorts 2A, 2B Only
Timepoint [2] 0 0
6 months after administration of ONC201 in the maintenance phase
Primary outcome [3] 0 0
Overall survival at 7 months (OS7) - Cohort 3A & 3B Only
Timepoint [3] 0 0
7 months after administration of ONC201 in the maintenance phase
Primary outcome [4] 0 0
Proportion of participants reporting dose-limiting toxicities (DLTs) (Cohort 4)
Timepoint [4] 0 0
Up through the first cycle of maintenance therapy, approximately 8 months
Primary outcome [5] 0 0
Number of participants requiring dose modification through first cycle of maintenance (Cohort 5)
Timepoint [5] 0 0
Up through the first cycle of maintenance therapy, approximately 8 months

Eligibility
Key inclusion criteria
* COHORT 1A AND 1B: (participants with newly diagnosed DMG prior to radiation therapy)

* New diagnosis of DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors. In cohort 1B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; World Health Organization (WHO) grade III and IV H3 wildtype gliomas.
* Must be within 6 weeks of diagnosis to begin standard of care radiation therapy on study.
* COHORT 2A AND 2B: (participants with DMG who have completed radiation therapy)

* Diagnosis of DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In Cohort 2B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.
* Participants must be within 4-14 weeks of completion of radiation.
* COHORT 3A AND 3B: (participants with DMG at progression)

* Diagnosis of recurrent DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In cohort 3B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.
* Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.
* COHORT 4A AND 4B:

* Diagnosis of DMG or recurrent DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors.
* Not currently eligible for any other clinical trials that include administration of ONC201.
* COHORT 5:

* Diagnosis of DMG or recurrent DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors.
* Not currently eligible for any other clinical trials that include administration of ONC201.
* Participant's tumor must demonstrate one of the following molecular alterations considered targetable by an approved agent but not limited to the ones listed below:

* BRAFV600E
* PDGFRA (DNA point mutation or amplification with >=5 copy numbers)
* FGFR1 (DNA point mutation, gene fusions, or amplification with >=5 copy numbers)
* NF1

All Cohorts

* Age 2 to 39 years
* Participants must have recovered from all acute side effects of prior therapy
* Participant body weight must be above the minimum necessary for the participant to receive ONC201 (at least 10 kg)
* From the projected start of scheduled study treatment, the following time periods must have elapsed: At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.

* For participants who have received radiotherapy, participants in Cohort 2 must be between 4 and 14 weeks from the completion of local up-front radiotherapy and not have received additional therapy beyond completion of radiation therapy.
* The use of bevacizumab to control radiation therapy-induced edema is allowed (if used for tumor-directed therapy, please see required time period above). Dosing limitations are as follows: Bevacizumab (or equivalent) for up to a maximum of 5 doses, dosing per institutional standard. There is no required washout period.
* Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg/m2 /dose continuously during radiation therapy for 42 days) or dexamethasone is allowed.
* Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 3 days prior to baseline magnetic resonance imaging (MRI) scan.
* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (1.0g/l) AND
* Platelet count >= 100,000/mm^3 (100x10^9/l) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR
* A serum creatinine within the normal limits for age
* Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age AND
* Serum glutamate pyruvate transaminase (SGPT)(alanine aminotransferase (ALT)) =< 2 x ULN AND
* Serum albumin >= 2 g/dL
* No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry of > 92% while breathing room air.
* Diarrhea < grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
* Non-fasting glucose < 125 mg/dL without the use of antihyperglycemic agents
* If non-fasting glucose > 125 mg/dL, a fasting glucose should be done. If fasting glucose =< 160 mg/dL without the use of antihyperglycemic agents, participants will meet adequate metabolic function criteria
* Triglycerides of < 300 mg/dl and total cholesterol of < 300 mg/dl - can be on lipid lowering medications as needed to achieve.
* No history of congestive heart failure or family history of long QT syndrome.
* ECG must be obtained to verify the QTC. If an abnormal reading is obtained, the ECG should be repeated in triplicate. QTC < 470 msec.
* Participants with history of congestive heart failure, at risk of having or have underlying cardiovascular disease, or with history of exposure to cardiotoxic drugs must have adequate cardiac function as determined by echocardiogram. Shortening fraction of >= 27%.
* Participants with seizure disorder may be enrolled if seizure disorder is well controlled
* The effects of the study drugs on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception. Adequate methods include: hormonal or barrier method of birth control; or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
* Karnofsky >= 50 for participants > 16 years of age and Lansky >= 50 for participants =< 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required. Participants who do not meet this criteria must be discussed with Study Chair(s).
* A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
Minimum age
2 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* COHORT 1A AND 1B (participants with newly diagnosed DMG prior to radiation therapy)

* Prior exposure to radiation therapy.
* Thalamic and Cerebellar H3K27M DMG.
* COHORT 2A AND 2B

* For tumors that do not have a pontine or spinal cord epicenter the following specific exclusion criteria apply:
* Thalamic and Cerebellar H3K27M DMG that has undergone standard radiation without concurrent therapy (other than temozolomide).
* COHORT 1A AND 2A (participants with newly diagnosed DMG prior to radiation therapy and who have not previously undergone tumor tissue collection prior to study entry)

* Deemed not appropriate for tissue resection/biopsy.
* COHORT 3A AND 3B (participants with DMG at progression)

* Prior exposure to re-irradiation for tumor progression.
* Participants who participated in trials investigating ONC201 in the upfront setting will not be eligible. Prior ONC201 exposure as part of PNOC022 or expanded access programs will be allowed.
* Thalamic and cerebellar H3K27M mutant DMG.
* COHORT 4

* Thalamic and cerebellar H3K27M mutant DMG, except those who received ONC201/ONC026 from alternative source prior to 2024.
* COHORT 5

* Thalamic and cerebellar H3K27M DMG, except those who received ONC201/ONC026 from alternative source prior to 2024.
* Drug specific exclusion criteria

All Cohorts:

* Participants who participated in trials investigating ONC201 in the upfront setting will not be eligible. Prior ONC201 exposure as part of PNOC022 or expanded access programs will be allowed.
* Diagnosis of a histone H3 wildtype grade II diffuse astrocytoma.
* Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy/resection should be discussed with the study chairs.
* Participants who are currently receiving other anti-cancer agents.
* Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy. Note: Participants that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the study chair.
* Participants with uncontrolled infection or other uncontrolled systemic illness.
* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).
* Active illicit drug use or diagnosis of alcoholism.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in study.
* Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of CSF dissemination.
* Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug.
* Concomitant use of potent CYP3A4/5 inhibitors during the treatment phase of the study and within 72 hours prior to starting study drug administration.
* Concomitant use of potent CYP3A4/5 inducers, which include enzyme inducing antiepileptic drugs (EIAEDs), during the treatment phase of the study and within 2 weeks prior to starting treatment. Concurrent corticosteroids is allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 0 0
Monash Children's Hospital - Clayton
Recruitment hospital [5] 0 0
The Royal Children's Hospital Melbourne - Melbourne
Recruitment hospital [6] 0 0
Perth Children's Hospital - Nedlands
Recruitment hospital [7] 0 0
Women and Children's Hospital - Adelaide
Recruitment hospital [8] 0 0
Sydney Children's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2152 - Westmead
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3052 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
2031 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Israel
State/province [17] 0 0
Ramat Gan
Country [18] 0 0
Israel
State/province [18] 0 0
Jerusalem
Country [19] 0 0
Netherlands
State/province [19] 0 0
Utrecht
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
Switzerland
State/province [21] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
University of California, San Francisco
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Chad-Tough Defeat DIPG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Mithil Prasad Foundation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Storm the Heavens Fund
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sabine Mueller, MD, PhD
Address 0 0
University of California, San Francisco
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kelly Hitchner
Address 0 0
Country 0 0
Phone 0 0
(415) 502-1600
Fax 0 0
Email 0 0
PNOC022@ucsf.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data after de-identification.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05009992

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 81
Perth Children's Hospital
Recruitment hospital [2] 82
Monash Children’s Hospital
Recruitment hospital [3] 83
The Royal Childrens Hospital
Recruitment hospital [4] 84
The Children's Hospital at Westmead
Recruitment hospital [5] 85
Queensland Children's Hospital
Recruitment hospital [6] 86
Sydney Children's Hospital
Recruitment hospital [7] 87
John Hunter Children's Hospital
Recruitment hospital [8] 88
Womens and Childrens Hospital
Recruitment postcode(s) [1] 85
6009
Recruitment postcode(s) [2] 86
3168
Recruitment postcode(s) [3] 87
3052
Recruitment postcode(s) [4] 88
2145
Recruitment postcode(s) [5] 89
4101
Recruitment postcode(s) [6] 90
2031
Recruitment postcode(s) [7] 91
2305
Recruitment postcode(s) [8] 92
5006
Recruiting in New Zealand
Province(s)/district(s)
Auckland Christchurch
Funding & Sponsors
Primary sponsor
University
Primary sponsor name
University of California
Primary sponsor address
675 Nelson Rising Lane, Rm402
San Francisco, California, 94158-0520
Primary sponsor country
United States of America
Secondary sponsor category [1] 71
Other Collaborative groups
Name [1] 71
ANZCHOG
Address [1] 71
27-31 Wright Street, Clayton, VIC, 3168
Country [1] 71
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 46
Children's Health Queensland Hospital and Health Service HREC
Address [1] 46
Level 7, Centre for Children's Health Research, Queensland Children's Hospital Precinct, 62 Graham St, South Brisbane, QLD, 4101
Country [1] 46
Australia
Date submitted for ethics approval [1] 46
22/11/2021
Approval date [1] 46
16/12/2021
Ethics approval number [1] 46
HREC/21/QCHQ/80895
 
Public notes

Contacts
Principal investigator
Title 325 0
Dr
Name 325 0
Geoffrey McCowage
Address 325 0
Dept of Oncology The Sydney Children's Hospital Network, Westmead Locked Bag 4001, Westmead, 4001, 2145
Country 325 0
Australia
Phone 325 0
02 9845 2134
Fax 325 0
Email 325 0
geoff.mccowage@health.nsw.gov.au
Contact person for public queries
Title 326 0
Dr
Name 326 0
Geoffrey McCowage
Address 326 0
Dept of Oncology The Sydney Children's Hospital Network, Westmead Locked Bag 4001, Westmead, 4001, 2145
Country 326 0
Australia
Phone 326 0
02 9845 2134
Fax 326 0
Email 326 0
geoff.mccowage@health.nsw.gov.au
Contact person for scientific queries
Title 327 0
Dr
Name 327 0
Geoffrey McCowage
Address 327 0
Dept of Oncology The Sydney Children's Hospital Network, Westmead Locked Bag 4001, Westmead, 4001, 2145
Country 327 0
Australia
Phone 327 0
02 9845 2134
Fax 327 0
Email 327 0
geoff.mccowage@health.nsw.gov.au