Clinical trial · Interventional
A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors
A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors
NCT01315431CI-TRIAL-00007546unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tesetaxel plus capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tesetaxel-capecitabine
- interventionNames
- Drug: Tesetaxel plus capecitabine
Primary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
- Through 30 days following the last dose of study medication
- description
- Percentage of subjects with adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age * Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma * Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.) * ECOG performance status of 0 or 1 * Adequate bone marrow, hepatic, and renal function * At least 3 weeks and recovery from effects of prior surgery and anticancer therapy, with resolution of any toxicity to not more than Grade 1 Exclusion Criteria: * Brain metastasis or leptomeningeal disease * Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years) * Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection * Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study * Significant medical disease other than cancer * Neuropathy at least Grade 2 * Difficulty swallowing * Malabsorptive disorder * Need for other anticancer treatment while receiving study medication * Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks is required prior to the first dose of study medication. * Pregnancy or lactation * History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of their components
References
Publications (0)
Data not yet available
No reference posted for this study.