Clinical trial · Interventional
A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer
A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is for people with advanced cancer for which no curative treatment exists. The purpose of this study is to test the safety and effectiveness of the combination of the drugs Temsirolimus and Capecitabine and see what effects it has on cancer. Temsirolimus is a drug that is given by vein that targets a protein important for the growth of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer cell growth and even lead to their death. Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in the body to the very common chemotherapy known as 5-fluorouracil. This research is being done because it is not known if the combination of Temsirolimus and Capecitabine will work better than Capecitabine or Temsirolimus alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temsirolimus and capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- temsirolimus and capecitabine
- description
- Treatment with the combination of temsirolimus and capecitabine
- interventionNames
- Drug: Temsirolimus and capecitabine
Primary outcomes (1)
- measure
- Identification of the recommended Phase II dose of temsirolimus to be used in combination with capecitabine in patients with advanced malignancies
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Evaluation of toxicity of the combination of temsirolimus plus capecitabine in patients with advanced malignancies as determined by adverse events observed and lab values
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma with measurable or evaluable disease * Disease for which capecitabine is approved or compendia listed * Advanced unresectable, and/or metastatic disease for which there is no known curative therapy * Performance status 0-2 * Adequate hepatic, bone marrow, and renal function Exclusion Criteria: * Brain metastases not under control for at least 3 months * Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus * Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months * Life-threatening visceral disease or other severe concurrent disease * Women who are pregnant or breastfeeding * Anticipated patient survival under 3 months
References
Publications (0)
Data not yet available