RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therap… (NCT02112565) | Clinical Trial Compass
Active — Not RecruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
United States12 participantsStarted 2016-06-13
Plain-language summary
This phase I trial studies the side effects and best dose of RNR Inhibitor City of Hope 29 (COH29) in treating patients with solid tumors that are refractory to standard therapy or for which no standard therapy exists. COH29 may inhibit an enzyme called ribonucleotide reductase and may interfere with the ability of tumor cells to grow.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients must have the ability to understand and the willingness to sign a written informed consent
* Life expectancy of greater than 3 months by physician assessment
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) solid tumor that is metastatic, unresectable, progressive, or recurrent, and for which standard curative or palliative measures do not exist or are no longer effective
* Patients must have measurable or evaluable disease
* Patients must not have received prior chemotherapy or radiation for \< 4 weeks prior to start of study treatment
* Patients may be entered if they have received prior radiation therapy involving =\< 30% of the bone marrow; any prior radiation therapy must have been administered \>= 4 weeks prior to start of study treatment and the patient must be recovered from the acute toxic effects of the treatment prior to start of study treatment
* Patients may be enrolled with a history of treated brain metastases that are clinically stable for \>= 4 weeks prior to start of study treatment
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; women of child-bearing age will undergo urine pregnancy testing prior to s…
What they're measuring
1
Maximum tolerated dose of RNR inhibitor COH29, defined as the dose level with no more than 1 dose limiting toxicity (DLT) in the first 6 patients at a dose level below a dose level with DLT in 2 of 6 patients, graded according to CTCAE version 4.0