Clinical trial · Interventional
DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
NCT00077077CI-TRIAL-00006934completedPhase 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)
RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| DJ-927 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor * Locally advanced or metastatic disease * Minimally pretreated * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin no greater than 1.5 times ULN Renal * Creatinine no greater than 1.5 times ULN Gastrointestinal * No prior chronic diarrhea * No swallowing and/or malabsorption problems * No diarrhea (excess of 2-3 stools/day above normal frequency in the past month) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No prior severe or life-threatening hypersensitivity reaction to a taxane or capecitabine * No concurrent serious infection * No neuropathy grade 2 or greater * No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No other severe or uncontrolled underlying medical disease that would preclude study participation * No psychiatric disorder that would preclude giving informed consent or study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic therapy Chemotherapy * Recovered from prior chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * Recovered from prior radiotherapy * No concurrent anticancer radiotherapy * Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective Surgery * At least 4 weeks since prior major surgery and recovered * No prior major surgery in the stomach or small intestine Other * At least 4 weeks since prior myelosuppressive therapy * More than 28 days since prior investigational drugs (including analgesics and/or antiemetics) * No other concurrent anticancer therapy * No other concurrent anticancer cytotoxic therapy
References
Publications (1)
- RESULTSaif MW, Sarantopoulos J, Patnaik A, Tolcher AW, Takimoto C, Beeram M. Tesetaxel, a new oral taxane, in combination with capecitabine: a phase I, dose-escalation study in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Dec;68(6):1565-73. doi: 10.1007/s00280-011-1639-3. Epub 2011 May 6. PMID 21547572