Palbociclib + Chemotherapy for Solid Tumors

Recruiting in Palo Alto (17 mi)

+144 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for children and young adults aged 2-21 with relapsed or refractory solid tumors, including specific types like Ewing sarcoma. They must have a certain level of physical ability, adequate organ function, measurable disease, and not be pregnant. Those with severe allergies to the drugs used or serious health issues are excluded.

Inclusion Criteria

My cancer has returned or didn't respond to treatment, as confirmed by a lab test.

My kidney function, measured by creatinine levels, is within the normal range.

My liver is working well.

See 7 more

Exclusion Criteria

Prior intolerability to specified treatments

I haven't taken strong CYP3A affecting drugs recently.

Severe acute or chronic medical or laboratory abnormalities

See 15 more

Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Irinotecan (Topoisomerase I inhibitors)
Palbociclib (CDK4/6 Inhibitor)
Temozolomide (Alkylating agents)
Topotecan (Topoisomerase I inhibitors)

Trial OverviewThe study tests Palbociclib combined with chemotherapy (Temozolomide/Irinotecan or Topotecan/Cyclophosphamide) to find the safest high dose in phase 1 and its effectiveness compared to just chemo in phase 2 for Ewing sarcoma.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2 Arm AExperimental Treatment3 Interventions

Palbociclib in combination with irinotecan and temozolomide.

Group II: Phase 1 Tumor specific cohort - NeuroblastomaExperimental Treatment3 Interventions

Palbociclib in combination with topotecan and cyclophosphamide.

Group III: Phase 1Experimental Treatment5 Interventions

Palbociclib in combination with temozolomide and irinotecan and/or with topotecan and cyclophosphamide.

Group IV: Phase 2 Arm BActive Control2 Interventions

Irinotecan and temozolomide alone.