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

NCT02146313

NCT02146313
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • Doctors expect you to live for at least 12 weeks
  • You are able to carry out normal daily activities with little or no limitation (confirm with trial site for exact definition)
  • You have at least one measurable area of disease that can be seen on a CT or MRI scan, meeting specific size requirements (confirm with trial site)
  • Your blood counts, kidney function, and liver function are at acceptable levels
  • You are using highly effective birth control as defined by the trial
  • For ovarian cancer patients: You have been diagnosed with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, confirmed by tissue testing
  • For ovarian cancer patients: Your cancer shows a specific protein marker called MUC16, shown either through a blood test (CA125) or tissue testing
  • For ovarian cancer patients: Your cancer got worse during or within 6 months of your most recent platinum-based chemotherapy treatment, confirmed by scan
  • For ovarian cancer patients (certain groups only): You have had no more than two prior chemotherapy treatments for platinum-resistant ovarian cancer
  • For pancreatic cancer patients: You have been diagnosed with advanced or spreading pancreatic ductal adenocarcinoma that cannot be removed by surgery, confirmed by tissue testing
  • For pancreatic cancer patients: Your cancer shows the MUC16 protein marker, confirmed by tissue testing
  • For pancreatic cancer patients: You have already received standard chemotherapy treatment, and no further standard treatments are available to you
  • For pancreatic cancer patients: You have had no more than two prior chemotherapy treatments for pancreatic cancer

Who may not be able to join:

  • You have received cancer treatments (such as chemotherapy, biological therapy, experimental therapy, or hormonal therapy) within the 4 weeks before starting the trial
  • You have previously been treated with therapies that specifically target the MUC16 protein (such as oregovomab or abagovomab), including a drug called DMUC5754A
  • You have previously received a type of drug called an MMAE-containing antibody-drug conjugate (confirm with trial site)
  • You have had radiation treatment to bone metastases within the 2 weeks before starting the trial
  • You have previously had radiation treatment to your lungs
  • You have had a major surgery within 4 weeks before starting the trial
  • You currently have an active infection (such as bacterial, viral, or fungal), including HIV, or you were hospitalised for a serious infection within the 4 weeks before starting the trial
  • You have significant uncontrolled health conditions such as eye problems, diabetes, heart disease, nerve disorders, kidney, liver, hormone, or digestive disorders, autoimmune disease, or a wound or fracture that is not healing
  • You have significant lung or breathing problems, an active lung infection, or your blood oxygen levels are below acceptable levels (confirm with trial site for full details)
  • You have a significant history of liver disease, including hepatitis, cirrhosis, or current alcohol misuse
  • You have had another cancer in the last 5 years, with some exceptions such as certain treated skin cancers or cervical changes (confirm with trial site)
  • You have untreated or currently active cancer that has spread to the brain or spinal cord (those with previously treated brain metastases may still be eligible — confirm with trial site)
  • You are currently experiencing side effects from previous cancer treatment above a mild level, or have nerve damage above a mild level from any cause
  • You have had a severe allergic reaction to a monoclonal antibody treatment in the past
  • You are pregnant or breastfeeding
  • You are unable to follow the study requirements and attend follow-up visits
  • You have any other condition or finding that your doctor believes could make the trial treatment unsafe for you or affect the trial results

Important: Always verify eligibility with the trial site directly before applying.

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
Genentech, Inc.
Registry
clinicaltrials_gov
Start date
22 June 2014
Est. completion
18 June 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of Participants with Dose-Limiting Toxicities (DLTs); Maximum Tolerated Dose of DMUC4064A; Recommended Part II Dose of DMUC4064A; Percentage of Participants with Adverse Events (AEs) or Serious Adverse Events (SAEs)

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