Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma

Atkins MB, Hidalgo M, Stadler WM, Logan TF, Dutcher JP, Hudes GR, Park Y, Liou SH, Marshall B, Boni JP, Dukart G, Sherman ML · 2004 · Journal of Clinical Oncology · Atlas ID ATK2004

What this study shows

In this randomised phase II trial, 111 patients with advanced renal cell carcinoma that had progressed on earlier therapy received temsirolimus (CCI-779) at 25, 75 or 250 mg as a weekly intravenous infusion. There was no control arm: randomisation compared dose levels only. The objective response rate was 7% (1 complete and 7 partial responses), with minor responses in a further 26%; median time to progression was 5.8 months and median survival 15.0 months. Neither efficacy nor toxicity differed significantly between the three doses, which supported taking the lowest dose (25 mg) forward. The commonest side effects were rash (76%), mouth sores (70%), weakness (50%) and nausea (43%); the commonest grade 3-4 events were high blood glucose (17%), low phosphate (13%), anaemia (9%) and high triglycerides (6%). Boundary: patients with advanced, previously treated kidney cancer; no placebo or active comparator, so survival figures cannot be attributed to the drug; risk-group analysis was retrospective.

Abstract

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To evaluate the efficacy, safety, and pharmacokinetics of multiple doses of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma (RCC). Patients (n = 111) were randomly assigned to receive 25, 75, or 250 mg CCI-779 weekly as a 30-minute intravenous infusion. Patients were evaluated for tumor response, time to tumor progression, survival, and adverse events. Blood samples were collected to determine CCI-779 pharmacokinetics.

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At a glance

Evidence type	H Human study Marked H because it is direct evidence from a human clinical trial or human cohort; the code names the kind of study, not its quality -- a small, well-run trial is still H.
Study type	2 - Human Clinical Trial
Model system	Humans: 111 patients with advanced refractory renal cell carcinoma, randomised to three weekly IV doses of temsirolimus (CCI-779)
Journal	Journal of Clinical Oncology
Year	2004
Peer reviewed	Yes
Record last updated	2026-10-01
Source	DOI 10.1200/jco.2004.08.185 · PMID 14990647

Extracted findings

These fields were extracted from the paper with AI assistance and have not been checked against the source. Read them as a pointer into the paper, not as curated claims; where they disagree with the curated summary above, the curated summary stands.

Intervention	Temsirolimus (CCI-779) 25, 75 or 250 mg IV weekly
Target	mTORC1 (via FKBP12)
Model	Human
Effect	Antitumour activity (7% objective response, median TTP 5.8 mo, median OS 15.0 mo), no dose-response for efficacy or toxicity

In the Atlas

Cite this paper

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Atkins, M. B., Hidalgo, M., Stadler, W. M., Logan, T. F., Dutcher, J. P., Hudes, G. R., Park, Y., Liou, S. H., Marshall, B., Boni, J. P., Dukart, G., & Sherman, M. L. (2004). Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2004.08.185

@article{ATK2004,
  author       = {Atkins, M. B. and Hidalgo, M. and Stadler, W. M. and Logan, T. F. and Dutcher, J. P. and Hudes, G. R. and Park, Y. and Liou, S. H. and Marshall, B. and Boni, J. P. and Dukart, G. and Sherman, M. L.},
  title        = {{Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma}},
  journal      = {Journal of Clinical Oncology},
  year         = {2004},
  doi          = {10.1200/jco.2004.08.185},
  note         = {PMID: 14990647},
}

Cite this Atlas record

The record is the Atlas's own work — the evidence label, the extracted findings and the links. It is cited as part of the dataset, not as the paper.

Barton, O. (2026). Oliver's mTOR Atlas (record ATK2004) [Data set]. https://mtor-atlas.org/study/ATK2004/ · Dataset DOI 10.5281/zenodo.22059963

@misc{atlas_ATK2004,
  author       = {Barton, Oliver},
  title        = {{Oliver's mTOR Atlas}, record ATK2004},
  howpublished = {Data set},
  year         = {2026},
  url          = {https://mtor-atlas.org/study/ATK2004/},
  doi          = {10.5281/zenodo.22059963}
}

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