CompletedPhase 1/2

Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors

United States, Canada76 participantsStarted 2014-03-28

Plain-language summary

This phase I/II trial studies the side effects and best dose of adavosertib and irinotecan hydrochloride in treating younger patients with solid tumors that have come back (relapsed) or that have not responded to standard therapy (refractory). Adavosertib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who can participate

Age range

1 Year – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG) * Part A: Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors * Part B: Patients with relapsed or refractory neuroblastoma * Part C: Patients with relapsed or refractory medulloblastoma or CNS embryonal tumors formally classified as PNET (pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes, medulloepithelioma, CNS embryonal tumor with rhabdoid features \[INI1 intact\] and CNS embryonal tumor, not otherwise specified) * Part D: Patients with relapsed or refractory rhabdomyosarcoma * Part A: Patients must have a body surface area \>= 0.35 m\^2 at the time of study enrollment if enrolling on dose levels 1-5; patients must have a body surface area \>= 0.46 m\^2 at the time of study enrollment if enrolling on dose level 0 * Parts B, C, and D: Phase 2 Expansion: Patients must have a body surface area of \> 0.49 m\^2 at the time of study enrollment at the recommended phase 2 dose of AZD-1775 * Part A: Patients must have either measurable or evaluable disease * Part B: Patients must have either measurable disease or must b…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: Up to 21 days

Number of Participants With Cycle 1 DLT

Timeframe: Up to 21 days

Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, AUC

Timeframe: Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2

Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Cmax

Timeframe: Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2

Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, HL-Lambda (Half Life)

Timeframe: Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2

Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Tmax

Timeframe: Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2

Trial details

NCT IDNCT02095132

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-12-31

Results submitted2022-02-08

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