A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small … (NCT04095221) | Clinical Trial Compass
CompletedPhase 1/2
A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma
United States21 participantsStarted 2019-09-17
Plain-language summary
The purpose of this study is to test whether the study drug prexasertib is a safe and effective treatment for people with DSRCT or RMS when given in combination with the standard drugs irinotecan and temozolomide. The study will test different doses of prexasertib in combination with irinotecan and temozolomide to find the highest dose of prexasertib that causes few or mild side effects in participants.
Who can participate
Age range12 Months
SexALL
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Inclusion Criteria:
* Consent/Assent: all patients and/or their parents or legally authorized representatives must sign written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
* Age: patients must be ≥12 months of age at the time of study enrollment
* Diagnosis: patients must have histologically documented locally advanced or metastatic desmoplastic small round cell tumor or rhabdomyosarcoma (confirmed at MSK)
* Therapeutic options: patient's current disease state must be one which has failed standard therapy and for which there is no known curative therapy
* Disease Status: patients must have measurable disease based on RECIST 1.1
* Performance level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
* Prior Therapy: patients may have had any number of prior therapies, but must have recovered from the acute toxic effects of all prior anti-cancer therapy (other than alopecia) as described below and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
°patients who have previously received irinotecan and/or temozolomide will be allowed
* 21 days must have elapsed after the last dose of cytotoxic or myelosuppressive chemotherapy
* 7 days must have elapsed after the last dose of anti-cancer agents not known to be myelosuppressive
* 14 days must have elapsed after radiation therapy, and toxicity related to prior radiation therap…