THERAPY DOSSIER · th-3243407b613a

Palbociclib (PD-0332991)

Drug · CDK6/cyclin D1 inhibitor; cyclin-dependent kinase 4/cyclin D1 inhibitor

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Evidence & regulatory context

Mechanism: CDK6/cyclin D1 inhibitor; cyclin-dependent kinase 4/cyclin D1 inhibitor
Target: CHEMBL2111455; CHEMBL1907601
Injury models: Radiation · Chemical/toxin
Reported indication: Not recorded
First approval: 2015
Development stage: Not recorded
ChEMBL record: CHEMBL189963 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Palbociclib; IBRANCE; PD-0332991; PD 0332991; Palbociclib isethionate
Note: Not recorded

Clinical trials 9

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT05065411 ↗PHASE3terminated

Phase 3 enobosarm+abemaciclib vs estrogen blocking agent 2nd line ER+HER2- MBC after palbociclib

Metastatic Breast Cancer

Enrolment: 5 · Results not recorded

NCT03784014 ↗PHASE3completed

Molecular profiling of advanced soft-tissue sarcomas (Phase III)

Soft Tissue Sarcoma

Enrolment: 603 · Results not recorded

NCT07061717 ↗PHASE3not yet recruiting

Phase III endocrine therapy with high-dose palbociclib and hydroxychloroquine vs standard-dose palbociclib HR+/HER2-

Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

Enrolment: 474 · Results not recorded

NCT04567420 ↗PHASE2active not recruiting

Randomized Phase II ctDNA-guided second line adjuvant palbociclib ER+/HER2- breast cancer (DARE)

Breast Cancer

Enrolment: 70 · Results not recorded

NCT02690480 ↗PHASE2unknown

Phase II fulvestrant +/- palbociclib first line (GEICAM/2014-12)

Breast Neoplasms

Enrolment: 189 · Results not recorded

NCT06895733 ↗PHASE1/PHASE2recruiting

Phase Ib/II pazopanib + palbociclib in refractory solid tumors with 11q13 co-amplification

Solid Tumor, Adult · Next-generation Sequencing · Precision Medicine

Enrolment: 65 · Results not recorded

NCT05563220 ↗PHASE1/PHASE2active not recruiting

Phase 1b/2 umbrella study of elacestrant combinations in metastatic breast cancer

Breast Cancer · Metastatic Breast Cancer

Enrolment: 435 · Results not recorded

NCT01918176 ↗PHASE1completed

Phase 1 crossover study of palbociclib with antacid in healthy subjects

Healthy

Enrolment: 26 · Results not recorded

NCT03065062 ↗PHASE1suspended

Phase I palbociclib + gedatolisib in advanced solid tumors

Lung Cancer Squamous Cell · Solid Tumors · Head & Neck Cancer · Pancreatic Cancer

Enrolment: 75 · Results not recorded

Preclinical evidence 2

2 studies reported at therapy level; 2 evidence entries itemised.

PMID 30056081 ↗2018Mixed findings

Blocking Cyclin-Dependent Kinase 4/6 During Single Dose Versus Fractionated Radiation Therapy Leads to Opposite Effects on Acute Gastrointestinal Toxicity in Mice.

MouseRadiationC57BL/6JMaleOral gavage120 mg/kg body weight, dissolved in sterile water at 10 mg/…28 and 4 h before irradiation (protective arm); or 4 and 24 h after 13 Gy (post…

Model: Gastrointestinal acute radiation syndrome from subtotal body irradiation with head and forelimbs shielded; single dose 15 Gy or 12 to 15 Gy for crypt survival, or fractionated 6 Gy or 6.5 Gy times 5 daily fractions, 320 kVp X-rays at 204 cGy/min

Palbociclib given 28 and 4 h before a single subtotal body irradiation dose significantly improved survival, gut barrier integrity and crypt survival, whereas the same drug given after irradiation had no effect. Given before and during five daily fractions it exacerbated gastrointestinal toxicity a…

Extraction: extract · Supplied extraction confidence: 0.9. Machine-extracted fields require source verification.

PMID 32402695 ↗2020Reported benefit

Inhibition of Rb phosphorylation leads to HS-mediated inhibition of NF-kB in acute pancreatitis and associated lung injury in mice.

MouseChemical/toxinSwissMaleIntraperitonealPalbociclib 25 mg/kg body weight1 h after the first caerulein injection

Model: Caerulein-induced acute pancreatitis with associated lung injury (6 consecutive hourly intraperitoneal injections)

Pharmacological inhibition of CDK4/6 and of hydrogen sulphide production improved pancreatic and lung histopathology, lowered serum amylase, myeloperoxidase activity and TNF-alpha, raised IL-10, and reduced NF-kappaB activation and alpha-SMA expression.

Extraction: extract · Supplied extraction confidence: 0.75. Machine-extracted fields require source verification.

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