AstrocytomaPhase 2TUVASTRATNCT07417761
Tuvusertib in Astrocytoma With ATRX Mutation
A Phase 2 study testing Tuvusertib in people with Astrocytoma, run by Grupo Español de Investigación en Neurooncología at 10 sites in Spain.
Trial summary
The TUVASTRAT study is a phase 2, non-randomized, two.cohort, CRS clinical trial of tuvusertib in patients with first recurrence of IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma (Grade 2-4 from WHO classification). The mutational status of IDH (required for diagnosis) is also required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma
- What is being tested?
- Tuvusertib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 10 sitesSpain
- Study dates
- 19 Dec 2025to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Patients, males and females, ≥ 18 years of age at the time of signing the informed consent.
- Patients with Karnofsky performance status (KPS) index > 60% (Appendix 5).
- Diagnosis of Grade 2-4 astrocytoma, IDH-mutated according to the 2021 WHO classification.
- Patients must have confirmed ATRX mutation (IHC or NGS sequencing) and p53 mutation (NGS sequencing). Evaluation of CDKN2A also is required by FISH or NGS.
- Patients must have progressive disease and evaluable disease according to RANO 2.0 criteria. All patients should have MRI contrast enhancement disease.
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- Patients must have undergone previous standard treatment with radiotherapy and chemotherapy (procarbazine, lomustine and vincristine [PCV] or temozolomide [TMZ]).
- Stable corticosteroid doses during the 2 weeks previous to the first dose of tuvusertib, maximum dose of dexamethasone 4 mg/day or equivalent.
- Adequate hematologic, hepatic and renal function as follows:
- Platelet count ≥ 100,000/mm3,
- Hemoglobin ≥ 9.0 g/dL,
- Absolute neutrophil count ≥ 1,500/μL with no growth factor treatment within the last 14 days,
- Total bilirubin level ≤ 1.5 × upper limit of normal (ULN) (if Gilbert's Syndrome may have total bilirubin > 1.5 × ULN),
- Aspartate aminotransferase (AST) level ≤ 3 × ULN, and an alanine aminotransferase (ALT) level ≤ 3 × ULN.
- Serum creatinine ≤ 1.5 × ULN. If serum creatinine is > 1.5 × ULN, creatinine clearance needs to be ≥ 50 mL/min, as estimated by Cockcroft-Gault
- Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies.
- Patients able to take oral medications.
- Willingness and ability of patients to comply with the protocol for the duration of the study including undergoing treatment as well as availability for scheduled visits and examinations including follow-up.
Who cannot join
- Patients with radiographic recurrence without contrast enhancement by MRI.
- Leptomeningeal dissemination and/or extracranial metastases.
- Patients who received more than 1 previous systemic line of treatment for astrocytoma.
- Patients who received previous treatment with bevacizumab.
- Persistence of AEs related to any prior treatments that have not recovered to Grade ≤ 1 unless AEs are clinically nonsignificant (e.g. alopecia) and/or stable on supportive therapy in the opinion of the Investigator.
- No prior ATR inhibitor and/or CHK1 inhibitor.
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- Concurrent treatment with a non permitted drug/intervention:
- Prohibited concomitant medication, as listed in Section 7.8.
- Anticancer treatment within 30 days or 5 half-lives, whichever is shorter, prior to Day 1 of study intervention (6 weeks for nitrosoureas or mitomycin C).
- Prior palliative radiotherapy to metastatic lesion(s) is permitted provided it was completed ≥ 12 weeks prior to study intervention administration and participants have recovered from all related radiotherapy toxicities to Grade ≤ 1.
- Another investigational drug within 30 days or 5 half-lives, whichever is shorter, prior to start of tuvusertib administration.
- Increasing dose of corticoids.
- Received hematopoietic growth factor (e.g., granulocyte colony-stimulating factor, erythropoietin) within 14 days prior to the first dose of tuvusertib.
- Significant cardiac disease:
- Unstable angina, myocardial infarction, congestive heart failure ≥ stage II) or a coronary revascularization procedure within 180 days of study entry.
- Calculated QTc average (using the Fridericia correction calculation) of > 450 msec for males and > 470 msec for females.
- Uncontrolled hypertension.
- Active and/or uncontrolled infection. The following exceptions apply:
- Participants with HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction
- Participants with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels < ULN, and provided there is no expected drug-drug interaction
- Participants with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load, and if they have ALT, AST, and total bilirubin levels < ULN.
- 11. Treatment with live or live attenuated vaccine within 30 days of dosing.
- 12. Known hypersensitivity to the components of tuvusertib.
- 13. Major surgery (as deemed by the Investigator) for any reason, except diagnostic biopsy, within 4 weeks of the study intervention and/or if the patient has not fully recovered from the surgery within 4 weeks of the study intervention.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Recruiting
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Responsible person Designated by the Sponsor, 0034934344412, Investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Not yet recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, 37007
Resposible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Clínico Universitario de Valencia - INCLIVA
Valencia, Valencia, 46010
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312
Responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, MD
About this study
Official title: Efficacy of Tuvusertib in Recurrent IDH Mutant Astrocytoma With ATRX Mutation, a Phase II Prospective Trial.
The TUVASTRAT study is a phase 2, non-randomized, two.cohort, CRS clinical trial of tuvusertib in patients with first recurrence of IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma (Grade 2-4 from WHO classification). The mutational status of IDH (required for diagnosis) is also required. CDKN2A and ATRX will be also determined locally as per standard of care.
All enrolled patients should have received first-line chemotherapy and have reported a contrast enhanced PD. Eligible patients are enrolled in two cohorts depending on their eligibility to undergo rescue surgery:
Read more
- Cohort A: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma NOT eligible for rescue surgery.
- Cohort B: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma candidates to rescue surgery.
The primary hypothesis is that treatment with tuvusertib, an ATR inhibitor, will improve the efficacy outcomes and increase the 6-months PFS rate from 45% reported by the standard therapies up to 65% in patients with recurrent IDH-mutated astrocytomas with ATRX mutation.
Clinic visits will occur every 3 weeks ±3 days. Tumor assessments by MRI according to RANO 2.0 criteria will be performed at baseline, and every 12 weeks +/-2 weeks (Q12W) until PD, patient withdrawal, start of new treatment line or death. This schedule must be maintained regardless of any delays in dosing. After the first suspect of progression, we recommend a second MRI at 4-8 weeks to confirm the progression, except if there is clinical progression. The MRI imaging will be assessed by PI and central radiologists.
The trial includes the assessment of safety (AEs, comorbidities) throughout the study period at every visit, the collection of health-related patient reported outcomes through validated questionnaires at baseline, coincident with the tumor assessments and at the safety visit. Neurologic / neurocognitive status will be assessed through validated tests administered by the physicians. Additionally, ATRX, IDH, P53 and CDK2A mutations will be centrally reviewed in tumor biopsies or archival tumor tissue obtained as close as possible to the baseline. PKs will be determined in sparse peripheral blood samples during the treatment phase.
The study includes a data safety monitoring committee (DSMC) to regularly review safety and efficacy. The DSMC will review efficacy and safety at least yearly and more frequently if deemed necessary.
- Conditions
- Astrocytoma
- Being tested
- Tuvusertib
- Keywords
- Tuvusertib, Astrocytoma, IDH mutated, ATRX mutated
- Medical subject headings
- Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TuvusertibDrug
All patients will receive tuvusertib at the recommended dose (for) expansion (RDE) of 180 mg daily (QD) during 2 weeks on and 1 week off.
| Study group | Role | What they receive |
|---|---|---|
| Tuvusertib treatment | Experimental | TUVASTRAT is a study including patients with first recurrence of IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma (Grade 2-4 from world health organization [WHO] classification).
All enrolled patients should have received first-line chemotherapy as per standard clinical practice and have evidence of tumor progression with contrast enhancement.
Patients included will be of the following two subgroups:
Cohort A: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma NOT eligible for rescue surgery.
Cohort B: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma candidates to rescue surgery. Receives: Drug: Tuvusertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-months progression-free survival (PFS) rate
defined as the proportion of patients alive and free of progression according to RANO 2.0 estimated by Kaplan-Meier.
Measured: At 6 months after the first dose of tuvusertib
Secondary outcomes (12)
Objective response (ORR)
defined as the percentage of patients who have achieved complete response (CR), or partial response (PR) as their best response throughout the study locally assessed by investigators and by central radiologists by magnetic resonance imaging (MRI) following RANO criteria v2.0
Measured: Throughout the study period, approximately an average of 2 year
Progression-free survival (PFS)
defined as the time from the first tuvusertib dosing date until the first documentation of disease progression or death from any cause, whichever occurs first. This endpoint will be locally assessed by investigators by magnetic resonance imaging (MRI) following RANO criteria v2.0. The median estimated by kaplan-Meier will be reported.
Measured: Throughout the study period, approximately an average of 2 year
Overall survival (OS)
defined as the time from the first tuvusertib dosing date to the date of death from any cause. The median estimated by kaplan-Meier will be reported.
Measured: Throughout the study period, approximately an average of 2 year
Time to Next Intervention (TTNI)
defined as the time from the first tuvusertib dosing date to the initiation of the first subsequent anticancer therapy (surgery, radiotherapy, chemotherapy or any antitumoral systemic treatment)
Measured: Throughout the study period, approximately an average of 2 year
Neurocognitive function changes by Hopkins Verbal Learning Test-Revised (HVLT-R)
Patients are assessed by means of validated neurocognition tests: Hopkins Verbal Learning Test-Revised (HVLT-R). A numerical value is attributed to each patient in baseline and the changes of that in subsequent assessments will be calculated as percentage decrease / increase. Here we report the number of patients experiencing an increase (better) or decrease (worse) in their neurocognitive function throughout the study.
Measured: Throughout the study period, approximately an average of 2 year
Neurocognitive function changes by Trail Making Test (TMT-A and TMT-B)
Patients are assessed by means of validated neurocognition tests: Trail Making Test (TMT-A and TMT-B). A numerical value is attributed to each patient in baseline and the changes of that in subsequent assessments will be calculated as percentage decrease / increase. Here we report the number of patients experiencing an increase (better) or decrease (worse) in their neurocognitive function throughout the study.
Measured: Throughout the study period, approximately an average of 2 year
Neurocognitive function changes by , Controlled Oral Word Association Test (COWA)
Patients are assessed by means of validated neurocognition tests: Controlled Oral Word Association Test (COWA). A numerical value is attributed to each patient in baseline and the changes of that in subsequent assessments will be calculated as percentage decrease / increase. Here we report the number of patients experiencing an increase (better) or decrease (worse) in their neurocognitive function throughout the study.
Measured: Throughout the study period, approximately an average of 2 year
Neurologic status changes by Mini Mental Test
Patients are assessed by means of validated Neurologic Assessment in Mini Mental tests. A numerical value is attributed to each patient in baseline and the changes of that in subsequent assessments will be calculated as percentage decrease / increase. Here we report the number of patients experiencing an increase (better) or decrease (worse) in their neurologic status throughout the study.
Measured: Throughout the study period, approximately an average of 2 year
Neurologic status changes by Neuro-Oncology Test
Patients are assessed by means of validated Neurologic Assessment in Neuro-Oncology Test (NANO). A numerical value is attributed to each patient in baseline and the changes of that in subsequent assessments will be calculated as percentage decrease / increase. Here we report the number of patients experiencing an increase (better) or decrease (worse) in their neurologic status throughout the study.
Measured: Throughout the study period, approximately an average of 2 year
Functional status changes
Patients are assessed by means of Barthel test and Karnofsky performance status (KPS) scale. A numerical value is attributed to each patient in baseline and the changes of that in subsequent assessments will be calculated as percentage decrease / increase. Here we report the number of patients experiencing an increase (better) or decrease (worse) in their functional status throughout the study.
Measured: Throughout the study period, approximately an average of 2 year
Treatment compliance
Number of patients who experience tuvusertib dose delays and interruptions due to toxicities
Measured: Throughout the study period, approximately an average of 2 year
Global quality of life (QoL) changes
assessed through the national cancer institute (NCI) - patient reported outcomes (PRO) -Common terminology Criteria for Adverse Events (CTCAE) Custom Survey questionnaire, and the Patient Global Impression of Change (PGIC) questionnaire. A numerical value is attributed to each patient in baseline and the changes of that in subsequent assessments will be calculated as percentage decrease / increase. Here we ONLY report the number of patients experiencing an increase (better) or decrease (worse) in their global QoL Score, being an unique measure or endpoint.
The global value is to be reported, no more than one outcome.
Measured: Throughout the study period, approximately an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start19 Dec 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Investigación en Neurooncología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estela Pineda, M.D.; Ph.D., Study chair, Medical Oncology, Hospital Clínic de BarcelonaMaria Vieito, M.D.; Ph.D., Study chair, Medical Oncology, Hospital Universitari Vall d'Hebrón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417761
- Sponsor's protocol ID
- GEINO-2401
- Other IDs
- 2025-521843-19-00, 2025
- Acronym
- TUVASTRAT
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tuvusertib in Recurrent IDH Mutant Astrocytoma With ATRX Mutation, a Phase II Prospective Trial.
- ClinicalTrials.gov ID
- NCT07417761
- Acronym / sponsor ID
- TUVASTRAT / GEINO-2401
- Conditions
- Astrocytoma
- Keywords
- Tuvusertib, Astrocytoma, IDH mutated, ATRX mutated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Grupo Español de Investigación en NeurooncologíaUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TUVASTRAT study is a phase 2, non-randomized, two.cohort, CRS clinical trial of tuvusertib in patients with first recurrence of IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma (Grade 2-4 from WHO classification). The mutational status of IDH (required for diagnosis) is also required. CDKN2A and ATRX will be also determined locally as per standard of care.
All enrolled patients should have received first-line chemotherapy and have reported a contrast enhanced PD. Eligible patients are enrolled in two cohorts depending on their eligibility to undergo rescue surgery:
- Cohort A: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma NOT eligible for rescue surgery.
- Cohort B: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma candidates to rescue surgery.
The primary hypothesis is that treatment with tuvusertib, an ATR inhibitor, will improve the efficacy outcomes and increase the 6-months PFS rate from 45% reported by the standard therapies up to 65% in patients with recurrent IDH-mutated astrocytomas with ATRX mutation.
Clinic visits will occur every 3 weeks ±3 days. Tumor assessments by MRI according to RANO 2.0 criteria will be performed at baseline, and every 12 weeks +/-2 weeks (Q12W) until PD, patient withdrawal, start of new treatment line or death. This schedule must be maintained regardless of any delays in dosing. After the first suspect of progression, we recommend a second MRI at 4-8 weeks to confirm the progression, except if there is clinical progression. The MRI imaging will be assessed by PI and central radiologists.
The trial includes the assessment of safety (AEs, comorbidities) throughout the study period at every visit, the collection of health-related patient reported outcomes through validated questionnaires at baseline, coincident with the tumor assessments and at the safety visit. Neurologic / neurocognitive status will be assessed through validated tests administered by the physicians. Additionally, ATRX, IDH, P53 and CDK2A mutations will be centrally reviewed in tumor biopsies or archival tumor tissue obtained as close as possible to the baseline. PKs will be determined in sparse peripheral blood samples during the treatment phase.
The study includes a data safety monitoring committee (DSMC) to regularly review safety and efficacy. The DSMC will review efficacy and safety at least yearly and more frequently if deemed necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tuvusertib treatment | Experimental | Drug: TuvusertibTUVASTRAT is a study including patients with first recurrence of IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma (Grade 2-4 from world health organization [WHO] classification). All enrolled patients should have received first-line chemotherapy as per standard clinical practice and have evidence of tumor progression with contrast enhancement. Patients included will be of the following two subgroups: Cohort A: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma NOT eligible for rescue surgery. Cohort B: First recurrence of IDH1/2-mutated, ATRX-mutated astrocytoma candidates to rescue surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Patients, males and females, ≥ 18 years of age at the time of signing the informed consent.
- Patients with Karnofsky performance status (KPS) index > 60% (Appendix 5).
- Diagnosis of Grade 2-4 astrocytoma, IDH-mutated according to the 2021 WHO classification.
- Patients must have confirmed ATRX mutation (IHC or NGS sequencing) and p53 mutation (NGS sequencing). Evaluation of CDKN2A also is required by FISH or NGS.
Key exclusion criteria (24 listed)
- Patients with radiographic recurrence without contrast enhancement by MRI.
- Leptomeningeal dissemination and/or extracranial metastases.
- Patients who received more than 1 previous systemic line of treatment for astrocytoma.
- Patients who received previous treatment with bevacizumab.
- Persistence of AEs related to any prior treatments that have not recovered to Grade ≤ 1 unless AEs are clinically nonsignificant (e.g. alopecia) and/or stable on supportive therapy in the opinion of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TuvusertibAll patients will receive tuvusertib at the recommended dose (for) expansion (RDE) of 180 mg daily (QD) during 2 weeks on and 1 week off. | Drug | Tuvusertib treatment |
Primary outcome
6-months progression-free survival (PFS) rate
Time frame: At 6 months after the first dose of tuvusertib
defined as the proportion of patients alive and free of progression according to RANO 2.0 estimated by Kaplan-Meier.
12 secondary outcomes
Objective response (ORR)
Time frame: Throughout the study period, approximately an average of 2 year
Progression-free survival (PFS)
Time frame: Throughout the study period, approximately an average of 2 year
Overall survival (OS)
Time frame: Throughout the study period, approximately an average of 2 year
Time to Next Intervention (TTNI)
Time frame: Throughout the study period, approximately an average of 2 year
Neurocognitive function changes by Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Throughout the study period, approximately an average of 2 year
Neurocognitive function changes by Trail Making Test (TMT-A and TMT-B)
Time frame: Throughout the study period, approximately an average of 2 year
Neurocognitive function changes by , Controlled Oral Word Association Test (COWA)
Time frame: Throughout the study period, approximately an average of 2 year
Neurologic status changes by Mini Mental Test
Time frame: Throughout the study period, approximately an average of 2 year
Neurologic status changes by Neuro-Oncology Test
Time frame: Throughout the study period, approximately an average of 2 year
Functional status changes
Time frame: Throughout the study period, approximately an average of 2 year
Treatment compliance
Time frame: Throughout the study period, approximately an average of 2 year
Global quality of life (QoL) changes
Time frame: Throughout the study period, approximately an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Estela Pineda, M.D.; Ph.D. study chair
Medical Oncology, Hospital Clínic de Barcelona
Maria Vieito, M.D.; Ph.D. study chair
Medical Oncology, Hospital Universitari Vall d'Hebrón
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tuvusertib in people with Astrocytoma, run by Grupo Español de Investigación en Neurooncología at 10 sites in Spain.
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 18 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GEINO Secretary (0034934344412, secretaria@geino.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-months progression-free survival (PFS) rate (time frame: At 6 months after the first dose of tuvusertib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.