Clinical trial · Interventional
CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors
A Phase 1 Trial of CCI-779 in Combination With EKB-569, an EGFR Inhibitor, in Patients With Solid Tumors
- 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 phase I trial is studying the side effects, best way to give, and best dose of CCI-779 and EKB-569 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. EKB-569 may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving CCI-779 together with EKB-569 may kill more tumor cells.
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 |
|---|---|---|---|
| pelitinib | Drug | — | UNRESOLVED |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21.
- interventionNames
- Drug: pelitinib
- Drug: temsirolimus
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients
- timeFrame
- Up to 28 days
- measure
- Number and severity of all adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
- timeFrame
- Up to 30 days after last dose of study treatment
- description
- Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unresectable solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy * No CNS metastases * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Bilirubin normal * AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver involvement) * Creatinine ≤ 1.5 times ULN * No New York Heart Association class III or IV heart disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * Fasting cholesterol \< 350 mg/dL * Fasting triglycerides \< 400 mg/dL * No uncontrolled infection * No seizure disorder * More than 4 weeks since prior immunotherapy * More than 4 weeks since prior biologic therapy * No concurrent immunotherapy * No concurrent prophylactic colony-stimulating factor therapy * More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent oral contraceptives * More than 4 weeks since prior radiotherapy * No prior radiotherapy to \> 30% of bone marrow * No concurrent radiotherapy * More than 7 days since prior CYP3A4 inducers * No prior mTOR-targeting agents * No prior epidermal growth factor receptor-targeting agents * No concurrent antiretroviral therapy that induces or inhibits CYP3A4 for HIV-positive patients * No other concurrent investigational agents * No concurrent warfarin
References
Publications (0)
Data not yet available