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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01155258

NCT01155258
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have a confirmed cancer that has spread or cannot be removed by surgery, and standard treatments no longer exist or are no longer working — specifically cancers of the lung, breast, ovary, cervix, prostate, uterus, kidney, bladder, or neuroendocrine tumors
  • You are reasonably active and able to care for yourself most of the time (based on a standard activity scale scored 0–2)
  • Your doctor expects you to live for at least 3 more months
  • You are willing and able to give your informed consent before any study procedures begin
  • If you are a woman who could become pregnant, you have a negative pregnancy test taken within 7 days before starting treatment
  • You are willing to use a reliable form of contraception throughout the study (this applies to both women who could become pregnant and sexually active men); post-menopausal women must have had no periods for at least 12 months
  • You have fully recovered from any serious side effects of previous surgery, chemotherapy, or radiation
  • Your blood counts and organ function meet specific healthy thresholds, including: white blood cell count, platelet count, hemoglobin (red blood cells), kidney function, liver function, and bilirubin levels (confirm with trial site)
  • You have little to no nerve damage (numbness, tingling, or weakness) in your hands or feet
  • You are not currently receiving any other cancer treatments

Who may not be able to join:

  • You have previously been treated with vinorelbine (a chemotherapy drug) or any mTOR inhibitor (a type of targeted therapy)
  • You have taken part in another clinical trial or received an experimental treatment within the last 30 days
  • Your last chemotherapy treatment ended less than 4 weeks before starting this study
  • You received radiation therapy within the last 4 weeks, unless it was short-term radiotherapy purely for pain relief
  • You still have side effects from a previous cancer treatment that are above a mild level (except for hair loss)
  • You have any nerve damage (affecting movement or sensation) at the time of joining the study
  • Your blood counts are too low — specifically white blood cells or platelets below required levels
  • Your liver function tests are above acceptable limits
  • You are currently taking certain strong medications that affect how the body processes drugs, including: ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, or voriconazole
  • You are currently taking certain other medications that may interfere with the study drugs, including rifabutin, rifampicin, rifapentine, carbamazepine, phenobarbital, phenytoin, or St. John's Wort (confirm with trial site)
  • You are on long-term steroid medication for an ongoing condition

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
University of Southern California
Registry
clinicaltrials_gov
Start date
1 June 2010
Est. completion
1 January 2013

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the maximum tolerated dose of Temsirolimus and Vinorelbine; To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov