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New treatment option for Ovary Cancer
Official title Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
ClinicalTrials.gov ID: NCT06617923
What this study is testing
What is Senaparib?
Senaparib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ovary cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed...
- Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or persistent clear cell or endometrioid ovarian, fallopian tube...
- 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...
- Pathogenic ARID1A mutation identified by other NGS tests will need to be confirmed by the study PI prior to enrollment.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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 people 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
What rules you out
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.