Phase 3 Ovarian Cancer Trial, Completed NCT01015118 Sponsor: Boehringer Ingelheim Condition: Ovarian Cancer
Back to Ovarian Cancer

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT01015118) enrolled 1,366 participants in total — 911 received nintedanib and 455 received a placebo (an inactive treatment used for comparison). The trial was measuring how long people with ovarian cancer went without their disease getting worse (called "progression-free survival"), as well as how long people lived overall, and changes in a blood marker called CA-125 that can be associated with ovarian cancer activity. It is worth noting that only 242 participants in the nintedanib group and 128 in the placebo group were recorded as completing the study, meaning the majority left the trial early for various reasons. The reported data shows that, for the main measure — time without disease worsening based on the investigators' assessments — the median figure (the midpoint value across all participants) was 17.2 months for the nintedanib group and 16.6 months for the placebo group. In a follow-up analysis conducted later, those figures were 17.6 months and 16.6 months respectively. Using a slightly different measurement method for a secondary outcome, the reported medians were 18.3 months (nintedanib) versus 16.6 months (placebo), and 18.4 versus 16.6 months in the follow-up. For overall survival — how long people lived from the start of the trial — the reported median was 62.0 months in the nintedanib group and 62.8 months in the placebo group. For the CA-125 blood marker, the reported median time before it rose to a defined threshold was 16.6 months in the nintedanib group and 14.1 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Ovarian Cancer Trial, Completed

NCT01015118
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have recently been diagnosed for the first time with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by a tissue sample (biopsy)
  • Your cancer is at an advanced stage (classified as stage IIB through IV)
  • You are female and aged 18 or older
  • Your doctors expect you to live for at least 6 months
  • You are reasonably active and able to care for yourself, or only need occasional help with daily activities (confirm with trial site)
  • You have already had surgery — either an operation to remove as much cancer as possible, or a biopsy/limited surgery if full removal was not possible for stage IV disease
  • You are willing and able to sign a written consent form agreeing to take part
  • Your first dose of chemotherapy is planned after your wound has healed, but no more than 10 weeks after your surgery

Who may not be able to join:

  • Your tumour is non-cancerous, borderline, or a type of cancer that did not start in the lining of the ovary, fallopian tube, or peritoneum
  • You have any surgery planned within about 2.5 years of joining the trial, including a delayed tumour-removal operation
  • You have a wound, ulcer, or bone fracture that is not healing properly
  • You have symptoms of a blocked bowel and need nutrition or fluids given directly into a vein
  • Your cancer has spread to the brain
  • You already have significant nerve damage causing numbness, tingling, or weakness, unless it was caused by a physical injury
  • You have had a serious blood clot in the past (such as a deep vein thrombosis or pulmonary embolism)
  • You have a known bleeding disorder, whether inherited or developed over time
  • You have significant heart or blood vessel disease
  • You have a clinically significant build-up of fluid around your heart
  • You have had a stroke, mini-stroke, or bleeding in the brain within the past 6 months
  • Your blood test results do not meet the minimum safety levels required for the trial (confirm with trial site)
  • You have a serious active infection, or infections such as Hepatitis B, Hepatitis C, or HIV
  • You have poorly controlled diabetes or another condition that would make high-dose steroid treatment unsafe
  • You have a stomach or bowel condition that would affect how your body absorbs the study medication
  • You have been diagnosed with another cancer in the past 5 years (some exceptions may apply for certain treated skin cancers, early cervical cancer, early breast cancer, or low-risk womb cancer — confirm with trial site)
  • You have previously had any treatment for ovarian cancer, such as chemotherapy, antibody therapy, targeted therapy, or hormone therapy
  • You have previously had chemotherapy for any reason
  • You have previously been treated with BIBF 1120 or any other drug that works by blocking the growth of blood vessels in tumours
  • You have previously had radiotherapy
  • You have a serious illness or condition — physical, neurological, or psychiatric — that could make participation risky
  • You are able to have children, are sexually active, and are not using a highly effective form of contraception during the trial and for at least 12 months after treatment ends
  • You are pregnant or breastfeeding
  • Personal, family, social, or location-related factors that might make it hard for you to follow the trial schedule (confirm with trial site)
  • You currently have an active problem with alcohol or drug misuse
  • You are unable to follow the requirements of the trial
  • You have any medical reason that means you cannot safely receive the chemotherapy drugs paclitaxel or carboplatin
  • You have taken part in another clinical drug trial or received an experimental treatment within the past 4 weeks, or are currently in another drug trial

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Boehringer Ingelheim, Boehringer Ingelheim

Australian sites

1199.15.61006 Boehringer Ingelheim Investigational Site, Camperdown, New South Wales
1199.15.61001 Boehringer Ingelheim Investigational Site, Waratah, New South Wales
1199.15.61004 Boehringer Ingelheim Investigational Site, Herston, Queensland
1199.15.61003 Boehringer Ingelheim Investigational Site, Southe Brisbane, Queensland
1199.15.61005 Boehringer Ingelheim Investigational Site, North Terrace, South Australia
1199.15.61007 Boehringer Ingelheim Investigational Site, Parkville, Victoria
1199.15.61002 Boehringer Ingelheim Investigational Site, Nedlands, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
17 November 2009
Est. completion
1 April 2013

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇸🇰 Slovakia 🇪🇸 Spain 🇸🇪 Sweden 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.; PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).

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: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov