CompletedPhase 1

Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

United States71 participantsStarted 2016-10-24

Plain-language summary

This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth in patients with advanced solid tumors.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * Patients must have histologically or cytologically confirmed solid organ malignancy * Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Leukocytes ≥ 3,000/mL * Absolute neutrophil count ≥ 1,500/mL * Platelets ≥ 100,000/mL * Hemoglobin ≥ 10 g/dL * Total bilirubin ≤ 1.5 × institutional upper limit of normal (except for patients with Gilbert disease) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 × institutional upper limit of normal (up to 5 X upper limit of normal \[ULN\] for patients with liver metastasis) * Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal * Women of child-bearing potential and men must agree to use adequate contraception (ho…

What they're measuring

Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Timeframe: Study completion, an average of 2 years

Incidence of dose limiting toxicities defined as grade 3 or higher toxicity

Timeframe: Up to 4 weeks

Recommended phase 2 dose (RP2D) as the highest doses of palbociclib and cisplatin or palbociclib and carboplatin

Timeframe: Study completion, an average of 2 years

Trial details

NCT IDNCT02897375

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-15

View on ClinicalTrials.gov More Solid Neoplasm trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

What they're measuring

Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Timeframe: Study completion, an average of 2 years

Incidence of dose limiting toxicities defined as grade 3 or higher toxicity

Timeframe: Up to 4 weeks

Recommended phase 2 dose (RP2D) as the highest doses of palbociclib and cisplatin or palbociclib and carboplatin

Timeframe: Study completion, an average of 2 years