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

NCT02835833

NCT02835833
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You are over 18 years old
  • You have been diagnosed (confirmed by tissue testing) with advanced or metastatic cancer of one of these types: kidney cancer, colorectal cancer, non-squamous non-small cell lung cancer, ovarian cancer that has stopped responding to platinum-based treatment, or cervical cancer
  • Doctors expect you to live for at least 3 months
  • You are generally able to care for yourself and are up and about for most of the day (confirm with trial site what this means for your situation)
  • Your cancer has gotten worse after receiving at least one prior treatment for advanced or metastatic disease
  • You have at least one area of cancer that can be measured on scans
  • Your liver, kidneys, blood counts, and other organ functions are within acceptable levels based on blood tests
  • You are willing and able to attend all appointments and follow the study schedule
  • You have recovered from most side effects of previous cancer treatments
  • You have read and signed a consent form agreeing to take part

Who may not be able to join:

  • You previously had serious, severe side effects from Bevacizumab treatment
  • You have previously been treated with Nintedanib, or you are known to be allergic to Nintedanib, peanuts, soya, or contrast dye used in scans
  • You have received chemotherapy, radiation (other than to the brain or limbs), hormone therapy, immunotherapy, or similar treatments within the past 4 weeks
  • The specific area of cancer being measured on scans received radiation treatment within the past 3 months
  • You still have significant side effects from previous chemotherapy or radiotherapy
  • Your cancer has spread to the brain or the lining of the brain or spinal cord, unless those areas were fully treated, are no longer active, you have no symptoms, and you have not needed steroids for at least 28 days
  • Your tumour is located near major blood vessels and appears to be growing into them on scans
  • You have taken part in another clinical trial or received an experimental drug within the past 4 weeks
  • You are currently taking blood-thinning medications or anti-clotting drugs (except very low-dose aspirin under 325mg per day, or low-dose heparin for keeping a drip line open)
  • You had a major surgery or serious injury in the past 4 weeks and your wound has not fully healed, or you have planned surgery during the trial
  • You had a significant bleeding or blood clot event in the past 6 months
  • You have an inherited condition that makes you more likely to bleed or form blood clots
  • You have serious heart problems such as uncontrolled high blood pressure, unstable chest pain, a heart attack in the past 6 months, significant heart failure, serious irregular heartbeat, or fluid around the heart
  • You have significant levels of protein in your urine
  • Your kidney function levels are too low based on blood tests
  • Your liver function test results are outside acceptable ranges
  • Your blood clotting test results are outside acceptable ranges
  • Your blood counts (white blood cells, platelets, or haemoglobin) are too low
  • You have had another cancer in the past 5 years, other than a certain type of minor skin cancer or very early-stage cervical changes
  • You have a serious active infection currently requiring antibiotic or antifungal treatment
  • You have an active or long-term hepatitis B or C infection
  • You have a digestive condition that would prevent you from absorbing the study drug properly
  • You have another serious illness or condition that the study doctor believes would make participation unsafe for you
  • You are sexually active and unwilling to use an effective form of contraception during the trial and for at least 3 months afterwards
  • You are pregnant or breastfeeding, or unwilling to take a pregnancy test before starting treatment
  • There are personal, family, social, or location-related reasons that might make it difficult for you to follow the study requirements
  • You are currently struggling with alcohol or drug misuse
  • You had a minor procedure such as a biopsy or port placement within 7 days of starting treatment
  • You have had a stroke, mini-stroke, arterial blood clot, or heart bypass surgery in the past 6 months
  • You have had bleeding in the lungs or coughed up blood in the past 6 months
  • You have open wounds or fractures that have not healed within

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
University of Alabama at Birmingham
Registry
clinicaltrials_gov
Start date
9 June 2016
Est. completion
14 April 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants with adverse events as a measure of safety and tolerability; Maximum tolerable dose of Nintedanib

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