Phase 3 Pancreatic Cancer Trial, Completed NCT00844649 Sponsor: Celgene Condition: Pancreatic Cancer
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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 (NCT00844649) enrolled 861 adults with pancreatic cancer — 431 in the group receiving a combination of two medicines (albumin-bound paclitaxel, also called ABI-007, plus gemcitabine) and 430 in the group receiving gemcitabine alone. The trial's main goal was to measure how long participants lived overall, and it also tracked how long their disease stayed stable before it progressed, as well as how many participants' tumours shrank or disappeared according to scans reviewed by independent specialists. The reported data shows that the median overall survival — that is, the midpoint time at which half the participants in each group had died — was 8.5 months in the combination group and 6.7 months in the gemcitabine-only group. For progression-free survival (the midpoint time until the disease worsened or participants died), the reported figures were 5.5 months in the combination group and 3.7 months in the gemcitabine-only group. When it came to tumour response, 23% of participants in the combination group were reported to have had their tumour shrink or disappear based on independent scan review, compared with 7% in the gemcitabine-only group. The reported data also shows that dose reductions and interruptions occurred in both groups during the treatment period, though the specific breakdown figures for each sub-category were not fully labelled in the submitted data. 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 Pancreatic Cancer Trial, Completed

NCT00844649
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 been diagnosed with pancreatic cancer (specifically adenocarcinoma) that has spread to other parts of the body (metastatic), confirmed by a tissue or cell sample
  • Your diagnosis of metastatic disease was made no more than 6 weeks before joining the study
  • At least one of your tumors that has spread can be measured by a CT scan or MRI
  • You are 18 years of age or older, and male or non-pregnant and non-breastfeeding female
  • If you could become pregnant, you must have a negative pregnancy test within 72 hours before starting the study drug, and you must agree to use contraception during and after treatment
  • You have not had any previous chemotherapy, radiation, or surgery for your metastatic disease (some prior treatments in an earlier stage setting may be allowed — confirm with trial site)
  • Your blood counts (white cells, platelets, and hemoglobin) are at acceptable levels, tested within 14 days before joining
  • Your liver, kidney, and other blood chemistry results are within acceptable ranges, tested within 14 days before joining
  • Your blood clotting tests are within normal range, tested within 14 days before joining
  • Your urine test shows no significant abnormalities, tested within 14 days before joining
  • You are in reasonably good general health, as measured by a standard performance scale (Karnofsky score of 70 or above)
  • You do not have yellowing of the skin (jaundice) at the start of treatment, any significant fluid buildup in your abdomen has been drained, and your pain is stable and not needing recent changes in pain medication
  • You have read and understood the study information and have signed a consent form agreeing to take part

Who may not be able to join:

  • You have cancer that has spread to the brain, unless it was treated successfully and has been stable for at least 3 months with no swelling and no steroid use
  • Your cancer has not spread beyond the pancreas area and is only locally advanced (not metastatic)
  • Your general health score dropped by 10% or more between your first assessment and within 72 hours before joining the study
  • Your blood protein (albumin) level dropped by 20% or more between your first assessment and within 72 hours before joining
  • You have had another cancer in the last 5 years (some exceptions apply for certain early-stage or skin cancers — confirm with trial site)
  • You take the blood-thinning medication Coumadin (warfarin)
  • You have an active, uncontrolled infection (bacterial, viral, or fungal) that requires treatment
  • You have a known history of HIV, hepatitis B, or hepatitis C
  • You have had major surgery within 4 weeks before the study start date (diagnostic biopsies without organ removal may be acceptable — confirm with trial site)
  • You have a known allergy or bad reaction to any of the study drugs or their ingredients
  • You have a history of connective tissue diseases such as lupus, scleroderma, or arteritis
  • You have a history of lung disease affecting the lung tissue (interstitial lung disease)
  • You have a history of chronic leukemia (such as chronic lymphocytic leukemia)
  • You have a high risk of heart problems, including a heart attack or coronary stenting in the past year
  • You have a history of poor blood circulation in the limbs (peripheral artery disease)
  • You have serious health problems affecting any major organ, or serious mental health conditions that could affect your safety or the study results
  • You are currently taking part in another clinical trial
  • You are unable or unwilling to follow the study procedures, or you plan to be away on vacation for 7 or more consecutive days during the study

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 16 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: Daniel Von Hoff, MD, Scottsdale Clinical Research Institute

Australian sites

Bankstown-Lidcombe Hospital, Bankstown, New South Wales
Macarthur Cancer Therapy Center, Campbelltown, New South Wales
Concord Hospital, Concord, New South Wales
St. Vincent's Hospital, Darlinghurst, New South Wales
Prince of Wales Hospital, Randwick, New South Wales
Newcastle Hospital, Waratah, New South Wales
Southern Medical Day Care Centre, Wollongong, New South Wales
Royal Brisbane and Women's Hospital, Herston, Queensland
Haemotology & Oncology Australasia (HOCA), Milton, Queensland
Haematology Oncology Clinics of Australasia-Gold Coast, Milton, Queensland
Adelaide Cancer Centre (T/A Ashford Cancer Ctr), Ashford, South Australia
Flinders Medical Center, Bedford Park, South Australia
Calvary North Adelaide Hospital, North Adelaide, South Australia
Royal Hobart Hospital, Hobart, Tasmania
Medical Oncology Unit, Bendigo Health, Bendigo, Victoria
Monash Medical Centre, East Bentleigh, Victoria
Western Hospital, Footscray, Victoria
Peninsula Oncology Centre, Frankston, Victoria
Alfred Hospital, Melbourne, Victoria
Border Medical Oncology, Wodonga, Victoria
Sir Charles Gairdner Hospital, Nedlands, Perth, 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
Sponsor
Celgene
Registry
ClinicalTrials.gov
Start date
1 March 2009
Est. completion
17 September 2012

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇷🇺 Russia 🇪🇸 Spain 🇺🇦 Ukraine 🇺🇸 United States

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

Primary endpoints

Overall Survival (OS)

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: 16 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