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Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC

Last updated on March 28, 2019

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Study Location
Hospital Universitario Fuenlabrada
Fuenlabrada, Madrid, 28942 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Pancreatic Ductal Adenocarcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Histologically or cytologically-confirmed metastatic pancreatic ductal adenocarcinoma.

- Availability of a tumor tissue specimen. If no archived tumor tissue is available,
then a de novo biopsy is required for patient participation.

- Karnofsky Performance Status 70 or greater.

- Adequate Bone Marrow, Renal, and Liver Function.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Prior treatment with a CDK 4/6 inhibitor.

- Prior treatment with nab-P for the treatment of metastatic disease.

- Patients with known CNS metastases, carcinomatous meningitis, or leptomeningeal
disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.

- Diagnosis of any other malignancy within 3 years prior to enrollment, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the cervix.

- QTc >480 msec, or family or personal history of long or short QT syndrome, Brugada
syndrome or known history of QTc prolongation, or Torsade de Pointes.

- Uncontrolled electrolyte disorders.

- Cardiac or pulmonary disorders within 6 months of enrollment.

- Known human immunodeficiency virus infection.

- History of interstitial lung disease or pneumonitis.

- Other severe acute or chronic medical or psychiatric condition that may increase the
risk associated with study participation.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to nab-P.

- Difficulty swallowing capsules or requirement for a feeding tube.

- Previous high-dose chemotherapy requiring stem cell rescue.

- Pregnant female patients; breastfeeding female patients; male patients with partners
currently pregnant.

- Active inflammatory or other gastrointestinal disease,

- Active bleeding disorder in the past 6 months.

- Patients treated within the last 7 days prior to the start of IP with strong/moderate
CYP3A4 inhibitors, strong/moderate CYP3A4 inducers, CYP2C8 inhibitors, strong/moderate
CYP2C8 inducers, or drugs that are known to prolong the QT interval.

NCT02501902
Pfizer
Completed
Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC

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[email protected]

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