Is NCT05128825 recruiting in Altamonte Springs, FL?

Yes, NCT05128825 is currently recruiting participants at its Altamonte Springs, FL location. This ovarian cancer clinical trial is actively enrolling qualified participants.

How do I join the ovarian cancer clinical trial in Altamonte Springs?

To join this clinical trial in Altamonte Springs, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Altamonte Springs clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Ovarian Cancer Clinical Trial in Altamonte Springs, FL

About This Ovarian Cancer Study in Altamonte Springs

This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.

Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Who Can Participate

Inclusion Criteria

Age ≥18 years

High-grade serous ovarian, fallopian tube or primary peritoneal cancer

Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay

Prior therapy:

Subjects must have platinum-resistant disease

Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)

Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol

Prior bevacizumab treatment is required, if eligible per standard of care

Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care

Prior mirvetuximab treatment is required, if eligible per standard of care

Measurable disease per RECIST Version 1.1.

Adequate hematologic and organ function, as defined in protocol

Exclusion Criteria

Primary platinum-refractory disease

Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors

Any of the following treatment interventions within the specified time frame prior to C1D1:

Major surgery within 28 days

Hospitalization within 14 days

Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);

Radiation therapy within 21 days;

Autologous or allogeneic stem cell transplant within 3 months.

Current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter).

Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strong or moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days prior to C1D1.

Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.

A serious illness or medical condition(s) including, but not limited to:

Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.

Myocardial impairment resulting in heart failure (NYHA Class II-IV)

Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or may interfere with interpretation of study results

Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.

Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for intravenous alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.

Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and afebrile) by the Investigator for at least 7 days before C1D1

Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.

Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).

Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.

History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.

Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.

Subjects with known active hepatitis B or hepatitis C infection.

Individuals who are judged by the Investigator to be unsuitable as study subjects.

Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Altamonte Springs?

Yes, this clinical trial (NCT05128825) has an active research site in Altamonte Springs, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Ovarian Cancer Treatment Options in Altamonte Springs, FL

If you're searching for ovarian cancer treatment options in Altamonte Springs, FL, this clinical trial (NCT05128825) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Altamonte Springs research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced ovarian cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ovarian cancer clinical trials near you to find additional studies recruiting in your area.

Ovarian Cancer Clinical Trial in Altamonte Springs, FL

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