Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma (NCT02959164) | Clinical Trial Compass
CompletedPhase 1
Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma
United States36 participantsStarted 2016-12-05
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have metastatic histologically or cytologically confirmed pancreatic adenocarcinoma or sarcoma (soft tissue or bone). Patient may enroll if he or she refuses first line therapy.
✓. Age ≥18 years.
✓. ECOG performance status ≤2 (Karnofsky ≥60% (See Appendix 1).
✓. Life expectancy of greater than 3 months (does not apply to pancreatic cancer population).
✓. Measureable disease per RECIST criteria.
✓. Patients must have normal organ and marrow function as defined below:
✓. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) from time of consent and for the duration of study participation as well as for 3 months after the completion of study drug. Adequate contraception consists of a double method of contraception, one method of which must be a barrier method.
✓. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
✕. Chemotherapy or radiotherapy within 4 weeks (for targeted therapies 5 half-lives) prior to entering the study or failure to recover from adverse events due to agents administered to \</= grade 1 or stable grade 2, at the discretion of the treating physician.
✕. Patients who are receiving any other investigational agents.
What they're measuring
1
Dose Limiting Toxicity - To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients
Timeframe: All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) up to 30 days after the last date of any study therapy
2
Tumor Response Rate - Change at evaluations
Timeframe: Change on two consecutive evaluations at least 8 weeks apart up to 30 days after the last date of any study therapy
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Decitabine or other agents used in study.
✕. Prior Decitabine for the treatment of this cancer. Patients with previous exposure to therapy with Gemcitabine are allowed in the study.
✕. Pregnant or breast feeding women are excluded from participating in this study. WOCBP must have a negative serum pregnancy test within 7 days of the first administration of Decitabine.
✕. Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required.
✕. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.