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Experimental drug cocktail targets tough childhood cancers in adults

NCT ID NCT01858168

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, olaparib and temozolomide (with or without irinotecan), in 49 adults with Ewing sarcoma or rhabdomyosarcoma that had come back or spread after standard chemotherapy. The main goal was to find the safest dose and see if the combo could shrink tumors. The drugs work by blocking cancer cells' ability to repair their DNA, making them more likely to die. This was an early-phase trial focused on safety, not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

49 people

The number who actually took part.

Started

Jul 2013

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed Ewing's sarcoma * Ewing's sarcoma must have progressed following at least one standard prior chemotherapy regimen * Life expectancy of at least 16 weeks * Willing to comply with the protocol for the duration of the study including pre- and post-treatment biopsies, undergoing treatment, scheduled visits and examinations including follow up * Presence of measurable disease * Prior approval from insurance company to obtain oral temozolomide for the duration of the study Exclusion Criteria: * Involvement in the planning and/or conduct of the study * Previous enrollment in the present study * Participation in another clinical study with an investigational product during the 21 days prior to first dose of olaparib and temozolomide * Receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment * Concurrent use of the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, protease inhibitors * Persistent clinically significant toxicities caused by previous cancer therapy * Previously documented diagnosis of myelodysplastic syndrome (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia * Symptomatic uncontrolled brain metastases * Major surgery within 14 days of starting study treatment * Considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection * Unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of study medication * Pregnant or breastfeeding * Known to be serologically positive for HIV and receiving antiviral therapy * Subjects with known active hepatitis B or C * Known hypersensitivity to olaparib or any of the excipients of the product * Uncontrolled seizures * Need to continue treatment with any prohibited medications or have not completed the appropriate washout period for a prohibited medication

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • St. Jude's Children's Research Hospital

    Memphis, Tennessee, 38105, United States

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