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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR TRIMETREXATE GLUCURONATE

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Clinical Trials for Trimetrexate Glucuronate

Trial ID Title Status Sponsor Phase Summary
NCT00000714 An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis Carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 To determine the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium (TMTX / LCV)) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have suffered severe or life-threatening ill effects from both conventional therapies for PCP. AMENDED: 08/01/90 As of August 31, 1989, 437 patients were enrolled into uncontrolled studies of trimetrexate for PCP:214 in TX 301/ACTG 0=039 (trimetrexate for patients intolerant of approved therapies) and 223 in NS 401 (trimetrexate for patients refractory to approved therapies). The analysis of overall response rate, stringently defined as having received at least 14 days of trimetrexate and being alive at follow-up 1 month after the completion of therapy, reveals 84/159 intolerant patients and 48/160 refractory patients had responded, for rates of 53 percent and 30 percent, respectively. These response rates include all individuals who received at least one dose of trimetrexate. Of the 111 patients who were ventilator-dependent at study entry, 18 completed a course of therapy and were alive a month later, for a response rate of 16 percent. All other ventilated patients died. The most common severe (grades 3 and 4) toxicities were: transaminase elevation (> 5 x normal) in 94 patients, anemia (< 7.9 g/dl) in 109, neutropenia (< 750 cells/mm3) in 58, fever (> 40 C) in 37, and thrombocytopenia (< 50000 platelets/mm3) in 27. Toxicity required discontinuation of therapy in approximately 5 percent of all patients. Original design: The drugs usually used to treat PCP in AIDS patients, trimethoprim / sulfamethoxazole and pentamidine, have had to be discontinued in many patients because of severe side effects. Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial because it was found to be very active against the PCP organism in laboratory tests. Also TMTX, in combination with LCV, had a high response rate and did not cause severe toxicity in a preliminary trial.
NCT00000724 A Study of Trimetrexate With Leucovorin Rescue for AIDS Patients Who Are Refractory to Standard Therapies for Pneumocystis Carinii Pneumonia Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 To study the safety and effectiveness of trimetrexate (TMTX) plus leucovorin calcium rescue (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, patients who are HIV positive, or those for whom laboratory confirmation of HIV infection has not yet been established if they are at high risk for HIV infection, and who have not responded to standard treatments or who have demonstrated severe or life-threatening intolerance to both conventional therapies for PCP. The drugs trimethoprim / sulfamethoxazole (TMP / SMX) and pentamidine, usually used to treat PCP in AIDS patients, have proven ineffective in many patients and have had to be discontinued in many other patients because of severe side effects. TMTX was chosen for this trial because it was found to be very active against the PCP organism in laboratory tests and, in a preliminary trial in combination with LCV, there was a high response rate without severe toxicity.
NCT00000730 Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 This study compares three different therapies for treatment of refractory Pneumocystis carinii pneumonia (PCP) in patients with AIDS. "Refractory" means that the patient has failed to respond to at least 4 days of treatment with either of two standard therapies: (1) sulfamethoxazole/trimethoprim (SMX/TMP) or (2) pentamidine (PEN). This study compares therapy with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus high-dose steroids (methylprednisolone). The purpose is to find better and safer forms of treatment for PCP in AIDS patients. There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and TMTX, but there is no information proving that these new treatments work better than the standard therapies.
NCT00000998 A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Trimetrexate Glucuronate

Condition Name

Condition Name for Trimetrexate Glucuronate
Intervention Trials
HIV Infections 12
Pneumonia, Pneumocystis Carinii 12
Sarcoma 3
Lymphoma 1
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Condition MeSH

Condition MeSH for Trimetrexate Glucuronate
Intervention Trials
Pneumonia, Pneumocystis 12
Pneumonia 12
HIV Infections 12
Osteosarcoma 3
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Clinical Trial Locations for Trimetrexate Glucuronate

Trials by Country

Trials by Country for Trimetrexate Glucuronate
Location Trials
United States 41
Argentina 1
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Trials by US State

Trials by US State for Trimetrexate Glucuronate
Location Trials
New York 6
Pennsylvania 5
California 5
South Carolina 3
Ohio 3
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Clinical Trial Progress for Trimetrexate Glucuronate

Clinical Trial Phase

Clinical Trial Phase for Trimetrexate Glucuronate
Clinical Trial Phase Trials
Phase 3 6
Phase 2 4
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Trimetrexate Glucuronate
Clinical Trial Phase Trials
Completed 16
Terminated 1
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Clinical Trial Sponsors for Trimetrexate Glucuronate

Sponsor Name

Sponsor Name for Trimetrexate Glucuronate
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 7
U.S. Bioscience 5
National Cancer Institute (NCI) 4
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Sponsor Type

Sponsor Type for Trimetrexate Glucuronate
Sponsor Trials
NIH 11
Industry 6
Other 5
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Express Scripts
McKesson
Mallinckrodt
Deloitte
Chinese Patent Office
Healthtrust
Queensland Health
Farmers Insurance

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