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Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
Phase 2 trial testing Laboratory Biomarker Analysis in Advanced Malignant Solid Neoplasm in 23 participants. Completed in 30 September 2024.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 13 August 2018 |
| Primary completion | 31 March 2023 |
| Estimated completion | 30 September 2024 |
| Sites | 117 locations across Puerto Rico, United States |
National Cancer Institute (NCI)
Adults 12 Months to 21, any sex, with Advanced Malignant Solid Neoplasm or Recurrent Childhood Ependymoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Defined as a patient who achieves a best response of partial response or complete response on the study. Confidence intervals will be constructed using the Wilson score interval method.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Palbociclib) | 0 | 0 – 0 |
PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Palbociclib) | 10 | 1.7 – 27.2 |
Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Palbociclib) | 100 | 100 – 100 |
Time frame: Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Palbociclib) |
|---|---|---|
| Disease progression | General disorders | — |
| Platelet count decreased | Investigations | — |
| Cardiac arrest | Cardiac disorders | — |
| Death NOS | General disorders | — |
| Edema limbs | General disorders | — |
| Pain | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Neuralgia | Nervous system disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Treatment (Palbociclib) |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Headache | Nervous system disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Creatinine increased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| GGT increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyperphosphatemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Insomnia | Psychiatric disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
Most-reported serious reactions: Disease progression, Platelet count decreased, Cardiac arrest, Death NOS, Edema limbs, Pain, Neutrophil count decreased, White blood cell decreased.
Data from ClinicalTrials.gov NCT03526250 adverse events section.
This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the proteins needed for cell growth.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing