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

NCT02028117

NCT02028117
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You are willing and able to give written consent and follow the study rules
  • You are 18 years old or older
  • You have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer (confirmed by tissue testing) that cannot be surgically removed
  • Your cancer has come back and stopped responding to platinum-based chemotherapy (meaning it got worse within 6 months of receiving that treatment), shown either by scans or a rising CA-125 blood test
  • Your cancer can be measured or detected on scans (the exact requirement depends on which part of the trial you join — confirm with trial site)
  • If you are due to receive the treatment directly into the abdomen, you are able to have a small tube placed in your abdomen and tolerate the related procedures
  • You have largely recovered from the side effects of any previous cancer treatments (hair loss aside) before starting this trial
  • You have a good general level of fitness and daily functioning (rated 0 or 1 on a standard scale used by doctors)
  • Your kidneys are working well, based on blood and urine tests
  • Your urine protein levels are within acceptable limits (confirm with trial site)
  • Your liver is functioning well, based on blood tests
  • Your blood counts (white cells, platelets, and red cells) are at acceptable levels
  • Your blood clotting ability is within a normal range
  • If you could become pregnant, you have a negative pregnancy test before joining the trial
  • If you are able to become pregnant and are not postmenopausal or surgically sterile, you agree to use two reliable forms of contraception (at least one that is more than 99% effective) during treatment and for at least 3 months after your last dose
  • If you are in a specific part of the trial involving tumour samples, your tumour must be reachable for a needle biopsy guided by imaging
  • Your blood complement levels (part of your immune system) are within the normal range

Who may not be able to join:

  • Your cancer is of a specific less common type, such as malignant mixed mesodermal, mucinous, Brenner, sex-cord, or other non-epithelial ovarian tumours
  • You are currently experiencing symptoms of a partial bowel blockage, such as regular bloating, nausea, vomiting, constipation, or diarrhoea
  • You are pregnant or breastfeeding
  • You have a significant problem with your immune system due to a condition such as HIV/AIDS, or you are taking high-dose steroid medicines or other immune-suppressing drugs
  • You have had your spleen completely removed
  • You have previously had a bone marrow or organ transplant from another person or from your own stored cells
  • You currently have an active infection that requires antibiotics or medical monitoring, or you have recurring fevers above 38°C linked to an active infection
  • You have an active viral illness, or your blood tests are positive for HIV, hepatitis B, or hepatitis C
  • You have taken certain antiviral medicines (such as ribavirin, adefovir, lamivudine, cidofovir, or pegylated interferon) in the days before starting the trial (confirm exact timeframes with trial site)
  • You have taken part in another clinical drug trial within the past 28 days
  • You are currently receiving any other cancer treatment alongside this trial
  • You have had major surgery within 2 weeks before your first dose
  • Depending on which part of the trial you join, you have had another type of cancer in the past 3 years (some exceptions apply — confirm with trial site)
  • You have cancer that has spread to your brain and is causing symptoms
  • You have an inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
  • You have heart failure or a significant heart condition
  • You have any other condition that, in the doctor's judgement, could put you at risk or affect the trial results
  • You have a known allergy to the study drug or any of its ingredients
  • You have any other medical or mental health condition that would prevent you from safely taking part or giving informed consent
  • You have a history of kidney disease, kidney injury, or most autoimmune diseases (some mild autoimmune conditions may still be acceptable — confirm with trial site)

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
Akamis Bio
Registry
clinicaltrials_gov
Start date
1 June 2014
Est. completion
19 November 2019

Where this trial is recruiting

🇪🇸 Spain 🇬🇧 United Kingdom

Primary endpoints

Phase I - maximum tolerated dose

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