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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02996825

NCT02996825
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • Your cancer must be one of the following types that has come back, and must test positive for a protein called "folate receptor alpha" (FRα) on a special lab test: ovarian, primary peritoneal, or fallopian tube cancer (but not low-grade, clear cell, or sarcomatoid types); endometrial (uterine) cancer; or triple-negative breast cancer (TNBC) confirmed by specific lab testing
  • You must have at least one tumor that can be measured on a scan, or — for ovarian/fallopian tube/peritoneal cancer only — a blood marker called CA-125 that is at least twice the normal level
  • You must have already tried standard treatments that are known to help your cancer type, and those treatments must have stopped working or you were unable to tolerate them
  • Your doctor expects you to live for more than 3 months
  • Your blood counts must be healthy enough (checked within 14 days of joining): enough white blood cells, platelets, and your liver and kidney function must be within acceptable ranges
  • If you could become pregnant, you must have a negative pregnancy test before starting and agree to use reliable birth control during the study and for 3 months after your last dose
  • You must agree to allow the trial team to study your existing stored tumor tissue
  • You must be willing and able to sign a consent form agreeing to take part
  • Any side effects from your most recent chemotherapy must have mostly cleared up (rated grade 1 or lower), except for hair loss
  • For TNBC patients (Cohort A): You must have had no more than 4 previous chemotherapy regimens, and must have already tried (or been unable to tolerate) certain standard chemotherapy drugs such as anthracyclines, taxanes, capecitabine, or eribulin
  • For endometrial cancer patients (Cohort B): You must have had no more than 2 previous chemotherapy regimens, and must have already tried (or been unable to tolerate) platinum-based drugs, taxanes, or liposomal doxorubicin
  • For ovarian/fallopian tube/peritoneal cancer patients (Cohort C): You must have had no more than 4 previous chemotherapy regimens, your cancer must no longer be responding to platinum-based chemotherapy, and you must have already tried (or been unable to tolerate) taxanes or liposomal doxorubicin; you must also agree to have a tumor biopsy 48–72 hours after your first treatment dose, if it is safe to do so

Who may not be able to join:

  • You have previously been treated with gemcitabine (one of the drugs used in this trial)
  • You have previously been treated with any experimental drug that targets the folate receptor
  • You have received chemotherapy, biological therapy, or other cancer treatments within the past 3 weeks (or 6 weeks for certain specific drugs) before starting the trial
  • You have received radiation therapy within the past 14 days before starting the trial
  • You have had another cancer in the past 3 years, unless it was a type of skin cancer (basal or squamous cell), a very early-stage bladder cancer, or a cancer confined to one area that was fully treated
  • You have cancer that has spread to the brain
  • You have a serious active infection, including known hepatitis B or C, HIV, shingles, cytomegalovirus, or any other infection currently requiring intravenous (IV) antibiotics
  • You have significant heart problems (such as heart failure, irregular heartbeat, or unstable chest pain), or have had a stroke within the past 6 months, or have a mental health or personal situation that would make it difficult to follow the trial requirements; an abnormal heart rhythm measurement (QT interval) above certain levels also applies (confirm with trial site)
  • You have a history of a lung condition called interstitial pneumonitis (scarring or inflammation of the lungs)
  • You have a history of serious liver scarring (cirrhosis)
  • You have nerve damage in your hands or feet worse than mild (greater than grade 1 peripheral neuropathy)
  • You have an active or ongoing eye condition, including Sjögren's syndrome, certain corneal diseases, a history of corneal transplant, active eye herpes, wet macular degeneration needing injections, diab

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
City of Hope Medical Center
Registry
clinicaltrials_gov
Start date
22 March 2017
Est. completion
9 February 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Recommended phase II dose assessed by Common Terminology Criteria for Adverse Events version 4

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov