Clinical trialPhase 2Unknown
Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer
Randomized Phase II Study of Weekly ABI-007 Plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- 12 December 2013
- Expected end
- July 2017
- Enrollment
- 114 participants
- Sites
- 15
- Primary outcomes
- Progression-free survival (PFS)
- Sponsor
- Other
- Results posted
- No
- Last update
- 31 January 2017
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Brief summary public domain (ClinicalTrials.gov)
To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.
Detailed description public domain (ClinicalTrials.gov)
Gemcitabine alone or the triplet combination of 5FU, irinotecan and oxaliplatin (FOLFIRINOX)are the reference 1st line treatment for metastatic pancreatic cancer. The aim of the AFUGEM study is to evaluate the efficacy of weekly ABI-007 in combination with weekly gemcitabine or with fortnightly simplified LV5FU2 regimen in terms of progression-free survival in patients with previously untreated metastatic pancreatic cancer. ABI-007 has been approved for commercialization in 38 countries, including the US, Canada, the EU, Australia, China, India and Korea for the treatment of women with metastatic breast cancer. ABI-007 alone and in combination is being evaluated in a number of cancers, including metastatic melanoma, non-small cell lung cancer, pancreatic cancer, and other solid tumors. Conditions which are responsive to paclitaxel such as non-hematological solid tumor malignancies are good clinical candidates for treatment with ABI-007.
Papers 3
- Registry-listed results paperNab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil as first-line therapy for metastatic p… DOI 10.1016/s2468-1253(17)30046-8↗
- Builds on itImpact on health-related quality of life deterioration-free survival of a first-line therapy combining nab-paclitaxel p… DOI 10.1002/cam4.2311↗
- Builds on itA randomized phase II study of weekly nab-paclitaxel plus gemcitabine or simplified LV5FU2 as first-line therapy in pat… DOI 10.1186/s12885-015-1656-4↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.