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

Last updated on March 28, 2019

Study Location
Hospital Universitario Fuenlabrada
Fuenlabrada, Madrid, 28942 Spain
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Pancreatic Ductal Adenocarcinoma
Females and Males
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.

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


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