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NCT00703170 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of DOXIL and Temsirolimus in Resistant Solid Malignancies
A Phase 1 study of Resistant Solid Malignancies, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT00703170 is a Phase 1 study of Resistant Solid Malignancies that has completed, run by Washington University School of Medicine. The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00703170, a Phase 1 study of Resistant Solid Malignancies, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Rationale: The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of 289 kDa; kinases have been shown to be important regulators of cancer cell cycle, proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the signaling of malignant cell growth, proliferation, differentiation, migration, and survival. Inhibition of mTOR would result in arrest of cell growth in the G1 phase of the cell cycle. Temsirolimus (CCI-779) is a soluble ester analogue of rapamycin (sirolimus) which has shown impressive in vitro and in vivo cytostatic activity in selectively inhibiting mTOR. In animal models, temsirolimus has demonstrated an impressive cytostatic effect on a wide variety of cancer cells. In vitro, it inhibited the growth of human T-cell leukemia, glioblastoma, melanoma, prostate, breast, renal cell, and pancreatic cells, all of which showed particular sensitivity to temsirolimus, with significant growth inhibition at concentrations of less that 0.01micrometer. In Phase I trials, temsirolimus has been investigated as a single agent on a weekly schedule as well as daily for 5 days every other week, and evidence of activity was observed over the entire dose range (15 - 220 mg/m2) in patients with both breast and renal cancer. There was no apparent relationship between exposure and clinical benefit, suggesting that the inhibition of mTOR may be achieved at doses well below dose levels that result in dose limiting toxicities. Major tumor responses were noted in Phase I trials in patients previously treated with lung, breast, renal as well as neuroendocrine tumors. Minor responses were noted in soft tissue sarcoma, endometrial, and cervical carcinoma. Pegylated liposomal doxorubicin has been FDA approved for use in refractory metastatic ovarian cancer and AIDS-related Kaposi's Sarcoma. It has also been shown to be effective in previously treated metastatic breast cancer. Combination studies in preclinical models
Conditions Studied
Interventions
- DRUG Temsirolimus
- DRUG Pegylated liposomal doxorubicin
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-03 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00703170
The ClinicalTrials.gov registry entry for NCT00703170 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Resistant Solid Malignancies appearing as the primary indexed condition, and to 2 interventions - of which Temsirolimus is the first listed.
NCT00703170 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT00703170 about?
NCT00703170 is a clinical study titled "Phase I Study of DOXIL and Temsirolimus in Resistant Solid Malignancies". Rationale: The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of 289 kDa; kinases have been shown to be important regulators of cancer cell cycle, proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the signaling of malignant...
What is the current status of trial NCT00703170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2008-03. Estimated completion is 2011-07.
What conditions does trial NCT00703170 study?
This clinical trial studies the following conditions: Resistant Solid Malignancies.
What interventions are being tested in trial NCT00703170?
The interventions under investigation include: Temsirolimus (DRUG), Pegylated liposomal doxorubicin (DRUG).
Who is sponsoring clinical trial NCT00703170?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00703170 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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