AzTrials
AzTrials

Ovary CancerPhase 2NCT06617923

Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer

A Phase 2 study testing Senaparib and Temozolomide in people with Ovary Cancer and Fallopian Tube Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a phase 2 study to test the effectiveness (anti-tumor activity) of the combination of the study drugs, Senaparib and Temozolomide, in patients with clear cell or endometrioid ovarian cancers that have ARID1A pathologic variants. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Senaparib and Temozolomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesUnited States
Study dates
6 Feb 2025to Dec 2029
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or persistent clear cell or endometrioid ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation (via the pathology report) indicating at least 50% endometrioid or clear cell morphology is required.
  • Presence of an ARID1A pathologic variant or likely pathogenic variant identified by next generation sequencing (NGS) tests (per criteria below)
  • Pathogenic or likely pathogenic ARID1A variant identified NGS tests performed by the labs listed on https://ecog-acrin.org/nci-match-eay131-designated-labs will be considered confirmed for the purposes of this study.
  • Pathogenic ARID1A mutation identified by other NGS tests will need to be confirmed by the study PI prior to enrollment.
  • All patients must have measurable disease, according to RECIST v1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. To be considered pathologically enlarged and measurable, a lymph node must be ≥15 mm in short axis when assessed by CT scan or MRI (CT scan slice thickness recommended to be no greater than 5 mm). See Section 12 for the evaluation of measurable disease.
Show all 30Show fewer
  • Patients who have received radiation must have evidence of measurable disease outside of the radiation field or have documented progression after radiation at the time of enrollment.
  • Patients must have received at least two prior cytotoxic regimens or have platinum-resistant (defined as having progressed within 6 months of last platinum therapy) or platinum-refractory (having progressed during primary platinum therapy) disease.
  • Participants can have received no more than 3 prior lines of cytotoxic therapy (any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow).
  • Unlimited prior hormonal therapy, targeted therapy (including immunotherapy) or antiangiogenic therapy will be permitted.
  • Patients must have completed prior therapy as detailed below:
  • Prior Therapy Time from last prior therapy to study treatment start date Chemotherapy (except nitrosoureas or mitomycin C) ≥ 28 days; Nitrosoureas or mitomycin C ≥ 42 days; Small molecule inhibitors ≥ 28 days; Monoclonal antibodies ≥ 28 days; Immunotherapy ≥ 28 days; Radiotherapy (RT) ≥ 28 days from last local site RT ≥ 28 days from stereotactic radiosurgery; ≥ 12 weeks from craniospinal ≥50% radiation of pelvis or total body irradiation Radiation related side effects must have resolved prior to study enrollment Endocrine therapy ≥ 7 days
  • Ability to take oral medications and not have gastrointestinal illnesses that would preclude absorption of senaparib or TMZ as judged by the treating physician.
  • Patients assigned female at birth, age ≥18 years. Because no dosing or adverse event data are currently available on the use of senaparib and TMZ in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A).
  • Patients must have adequate organ and marrow function as defined below:
  • Absolute Neutrophil Count ≥1,000/microliter (mcL);
  • Differential Differential with no clinically significant morphologic abnormalities on complete blood count (CBC) testing.
  • Manual differential is encouraged, if clinically indicated, and in cases where an automated differential is abnormal.
  • Hemoglobin ≥9 g/dL;
  • Platelets ≥100,000/mcL;
  • aspartate transferase (AST) (SGOT) or Alanine Transaminase (ALT) (SGPT) ≤3 × institutional ULN;
  • Total Bilirubin ≤1.5 × institutional ULN; Direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's Syndrome are eligible)
  • Creatinine -OR- Glomerular Filtration Rate ≤ institutional upper limit normal (ULN) -OR- ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional ULN
  • Because of the potential DNA damaging effects in a developing human fetus with the study treatment, participants of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation including for one month after last dose of senaparib or temozolomide. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Theoretically, CYP3A induction with senaparib use may result in the loss of efficacy in hormonal contraceptives, thus a barrier method of contraception must be used in addition to hormonal contraceptives due to the potential drug-drug interaction with senaparib. Note: All females will be considered to be of childbearing potential unless postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
  • For patients with known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated and the suppressive therapy must not be an excluded concurrent medication.
  • Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the patients are eligible if the patient has an undetectable HCV viral load and the HCV therapy is not an excluded concurrent medication.
  • Patients with treated brain metastases are eligible if follow-up brain imaging ≥ 12 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, with permission of the protocol chair.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

Who cannot join

  • Prior treatment with a poly ADP ribose polymerase (PARP) inhibitor or temozolomide.
  • Patients who are currently receiving or have previously received any other investigational agents within 3 weeks prior to entering the study.
  • Patients who have not recovered (CTCAE v5 grade ≤1) from adverse events due to agents administered more than 4 weeks earlier, unless those events are deemed to have returned to baseline, are irreversible, or are unlikely to develop into a life-threatening condition at the permission of the Protocol Chair (e.g., alopecia).
  • Patients who have any of the following:
  • A prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
  • Abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing.
Show all 23Show fewer
  • A prior history of T-cell lymphoblastic lymphoma/lymphoblastic leukemia (T-ALL).
  • Patients with clinical or radiographic evidence of bowel obstruction.
  • Severe, active comorbidity per the treating investigator's clinical discretion.
  • Pregnant or lactating patients.
  • Patients with known human immunodeficiency virus (HIV) infection are ineligible because the treatments involved in this protocol may be immunosuppressive, increasing the risk of lethal infections in this patient population.
  • Patients with known, untreated brain metastases, as progressive neurologic dysfunction may develop that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to senaparib or temozolomide.
  • Strong CYP3A4 inhibitors or inducers should not be used within 3 days of Day 1 dosing until the end of study. Moderate CYP3A4 inhibitors or inducers should be used with caution.
  • Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http://medicine.iupui.edu/ clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Uncontrolled intercurrent illness including, but not limited to, the following:
  • ongoing or active infection, including latent tuberculosis infection,
  • clinically significant GI disease (such as active Crohn's disease or ulcerative colitis),
  • recent or significant cardiovascular disease (defined as any major CV event within the previous 6 months including myocardial infarction, unstable angina, cardiac arrhythmia, stroke, Pulmonary Embolism (PE), or New York Heart Association Class III or IV heart failure),
  • history of liver function abnormality requiring investigation, drug induced liver injury, chronic liver disease, excessive alcohol consumption or chronic alcohol-induced disease,
  • psychiatric illness/social situations that would limit compliance with study requirements, or
  • any other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of senaparib and temozolomide. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study. These potential risks may also apply to other agents used in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase 2 Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer

This is a phase 2 study to test the effectiveness (anti-tumor activity) of the combination of the study drugs, Senaparib and Temozolomide, in patients with clear cell or endometrioid ovarian cancers that have ARID1A pathologic variants.

Read the detailed description

This is a single-arm phase 2, two-stage, non-randomized multicenter Phase 2 study designed to evaluate the clinical activity (response frequency) of senaparib and temozolomide (TMZ) in patients with recurrent or persistent clear cell or endometrioid ovarian cancer.

Up to 18 adult female subjects will be enrolled and receive senaparib 80mg orally daily Days 1-28 and TMZ 20mg daily Days 1-21 of a 28 day cycle. Tumor assessments will be performed every 8 weeks for first 3 cycles then every 12 weeks thereafter until progressive disease is confirmed. Treatment will continue until either unacceptable toxicity, progression of disease, or withdrawal of consent.

Being tested
Senaparib, Temozolomide
Keywords
ovarian, endometrioid, clear cell, ARID1A mutation
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SenaparibDrug

    Participants will receive orally 80mg daily Days 1-28 of a 28 day cycle.

  • TemozolomideDrug

    Also called TMZ

    Participants will receive orally 20mg daily Days 1-21 of a 28 day cycle.

Study groups in NCT06617923
Study groupRoleWhat they receive
TreatmentExperimentalSenaparib 80mg Temozolomide 20mg
Receives: Drug: Senaparib; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Clinical activity (response frequency) of Senaparib and Temozolomide. The primary endpoint of clinical activity is the objective response rate (ORR) defined as complete response (CR) + partial response (PR). Tumor response is defined by RECIST v 1.1. If a patient fails to respond (or has stable disease), the patient will be defined as a non-responder in the analysis. ORR will be estimated using binomial distribution together with 95% Clopper-Pearson confidence interval.

    Measured: 3 years

Secondary outcomes (2)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Examine the nature and degree of toxicity in patients treated with this regimen.

    Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), serious AEs (SAEs). Frequency and severity (grades based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0 of AEs will be summarized by system organ class, preferred term, and relation to study drug.

    Measured: 3 years

  2. Frequency of Grade 3 and 4 Adverse Events

    Number of Grade 3 and 4 treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria will be summarized.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start6 Feb 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Model description
two-stage, non-randomized
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06617923
Sponsor's protocol ID
J2467sIRB
Other IDs
IRB00443678
Status last verified
Oct 2026
First submitted
19 Sep 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Senaparib and Temozolomide in people with Ovary Cancer and Fallopian Tube Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

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 30 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06617923.

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 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in