Clinical trialPhase 1Completed
Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma
A Phase 1b Study: Treatment of Refractory Pancreatic Adenocarcinoma and Advanced Soft Tissue or Bone Sarcomas Using Decitabine Combined With Gemcitabine
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 5 December 2016
- Expected end
- 16 October 2020
- Enrollment
- 36 participants
- Sites
- 1
- Primary outcomes
- Dose Limiting Toxicity - To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients; Tumor Response Rate - Change at evaluations
- Sponsor
- Other
- Results posted
- No
- Last update
- 28 July 2023
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this Phase 1b study is to assess the safety and maximum tolerated dose (MTD) of Decitabine in combination with Gemcitabine among previously treated patients diagnosed with advanced pancreatic adenocarcinoma or sarcoma (soft tissue and bone).
Detailed description public domain (ClinicalTrials.gov)
The objectives of this study are to assess the safety and tolerability of the combination of Decitabine with Gemcitabine in previously treated patients with advanced pancreatic cancer and advanced sarcoma and to define the recommended Phase II dose and describe the dose-limiting toxicity of the combination of Decitabine with Gemcitabine. The preliminary efficacy parameters of the combination of Decitabine with Gemcitabine will be estimated in terms of response rate, disease control rate and progression-free survival.