Is NCT07546500 recruiting in Columbus, OH?

Yes, NCT07546500 is currently recruiting participants at its Columbus, OH location. This ovarian cancer clinical trial is actively enrolling qualified participants.

How do I join the ovarian cancer clinical trial in Columbus?

To join this clinical trial in Columbus, 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 Columbus 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 Columbus, OH

About This Ovarian Cancer Study in Columbus

This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.

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

Who Can Participate

Inclusion Criteria

Female age ≥ 18 years

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

Measurable disease per RECIST Version 1.1

Eastern Cooperative Oncology Group (ECOG) performance status score 0-1

The subject's tumor tissue must be positive for cyclin E1 protein expression per the Sponsor's clinically validated cyclin E1 IHC investigational, in vitro diagnostic assay

Prior Therapy:

Subject must have platinum-resistant disease

One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)

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

Adequate hematologic and organ function during the screening period

Exclusion Criteria

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, nonmelanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.

Subjects with primary platinum-refractory disease.

Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.

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

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

Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.

Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV 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.

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

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 randomization

Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).

Medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results

Any of the following treatment interventions within the specified time frame before randomization:

Hospitalization within 14 days

Major surgery within 28 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 with prescription or nonprescription drugs that are prohibited per protocol.

Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol

Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

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

Subjects who are 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

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 Columbus?

Yes, this clinical trial (NCT07546500) has an active research site in Columbus, OH 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 Columbus, OH

If you're searching for ovarian cancer treatment options in Columbus, OH, this clinical trial (NCT07546500) 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 Columbus research site is actively enrolling participants for this 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 Columbus, OH

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