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Anti-tumor chemotherapy

Assay-Directed Chemotherapy for Ovarian Cancer

Phase 3

Waitlist Available

Research Sponsored by Cordgenics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test for women of childbearing potential

Participant has disease of specific histologic epithelial cell types

Must not have

Participant has ovarian stromal, germ cell tumors or pure sarcomas

Use of Avastin planned to treat participant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a test that predicts how a person will respond to chemotherapy can help treat ovarian cancer.

Who is the study for?

This trial is for women over 18 with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. They should have had ≤ 5 prior treatments and a good performance status. Participants must not be pregnant, using effective contraception if of childbearing potential, and able to provide tumor samples.

What is being tested?

The study tests if ChemoID assay can predict the effectiveness of chemotherapy in treating certain types of ovarian cancer. Women will receive standard chemotherapy guided by the results of this assay to see if it improves treatment outcomes.

What are the potential side effects?

Side effects are not specified but may include those typically associated with standard chemotherapy such as nausea, fatigue, hair loss, increased risk of infection, and possible discomfort from biopsy procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

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My cancer originates from certain types of lining cells.

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I've had 5 or fewer treatments for my cancer, including one with platinum.

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I am a woman and I am 18 years old or older.

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I have a type of ovarian, peritoneal, or fallopian tube cancer that has come back and does not respond to platinum-based chemotherapy.

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I can provide a fresh sample for ChemoID testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a specific type of ovarian cancer.

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I am planned to be treated with Avastin.

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I am not using any herbal or alternative medicines.

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My cancer is a type of borderline, mucinous, or low-grade serous carcinoma.

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My only cancer site is in the fluid-filled areas of my body.

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I have heart problems that cause symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate

Secondary study objectives

CA125 levels

Duration of Response

Health-Related Quality of Life (HRQOL)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ChemoID-guided treatmentExperimental Treatment1 Intervention

Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations: * Liposomal Doxorubicin; * Docetaxel; * Paclitaxel; * Carboplatin; * Cisplatin; * Gemcitabine; * Topotecan; * Carboplatin, Gemcitabine; * Cisplatin, Gemcitabine; * Carboplatin, Liposomal Doxorubicin; * Carboplatin, Paclitaxel; * Carboplatin, Docetaxel. The treating physician will receive the ChemoID assay results from the ChemoID lab.

Group II: Physician Choice TreatmentActive Control2 Interventions

Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the physician from the provided list). Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations: * Liposomal Doxorubicin; * Docetaxel; * Paclitaxel; * Carboplatin; * Cisplatin; * Gemcitabine; * Topotecan; * Carboplatin, Gemcitabine; * Cisplatin, Gemcitabine; * Carboplatin, Liposomal Doxorubicin; * Carboplatin, Paclitaxel; * Carboplatin, Docetaxel. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab.

0 / 12Eligibility criteria met