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

Last updated on October 15, 2019

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Descriptive Information
Brief Title  ICMJE Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC
Official Title  ICMJE AN OPEN-LABEL PHASE IB STUDY OF PALBOCICLIB (ORAL CDK 4/6 INHIBITOR) PLUS ABRAXANE (REGISTERED) (NAB-PACLITAXEL) IN PATIENTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
Brief SummaryThis is a Phase 1, open label, multi center, multiple dose, dose escalation, safety, pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately 30-60 patients are expected to be enrolled in the overall study.
Detailed Description

The study has 2 parts:

? Part A (Dose-Escalation Cohorts): Consecutive cohorts of patients will receive escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles, in order to estimate the MTD(s) of the combination. The starting doses will be 75 mg palbociclib, and 100 mg/m2 nab-P. The observation period for dose-limiting toxicities (DLTs) will be from Day 1 to Day 28. Pharmacokinetic (PK) and pharmacodynamic (PD) properties of palbociclib and nab-P will also be assessed. Up to approximately 30 patients will be enrolled. The criteria for dose escalation will be based on a modified toxicity probability interval (mTPI) method.

? Part B [MTD Expansion Cohort(s)]: When the MTD(s) of palbociclib plus nab-P has been estimated with confidence, enrollment will proceed into 1 or 2 MTD expansion cohort(s) of up to 20 patients each at the MTD(s). The objective of the MTD expansion cohort(s) will be to provide additional information on safety, tolerability, biomarkers, PD activity, and PK/PD relationship for the combination regimen in order to determine the RP2D. The MTD expansion cohort(s) will only enroll patients who have not received previous treatment for their metastatic disease in order to evaluate preliminary activity of the combination in the target patient population.

All patients (in Part A and B) will receive nab-P intravenously once weekly for 3 weeks out of each 28-day cycle. Palbociclib oral dosing will be once daily on Days 1-21 of each 28-day cycle. To allow for PK evaluation of nab-P administered alone, nab-P will be administered on Day -2 for Cycle 1 only. Subsequent cycles will administer both nab-P and palbociclib on Day 1. Alternate dosing schedules for palbociclib may be explored based on emerging PK, PD, and safety data.

Patients will be treated as long as they are clinically benefiting from investigational product without unacceptable toxicity, objective disease progression, or withdrawal of consent. A modified visit schedule will be implemented for patients who are on investigational product for more than 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Ductal Adenocarcinoma
Intervention  ICMJE
  • Drug: Palbociclib
    Palbociclib oral dosing on Days 1 to 21 of each 28-day cycle.
    Other Name: Ibrance
  • Drug: Nab-Paclitaxel
    Nab-paclitaxel IV dosing on Days -2, 6, and 13 of Cycle 1, and on Days 1, 8, and 15 of subsequent cycles.
    Other Name: Abraxane
Study Arms  ICMJE Experimental: Palbociclib + Nab-Paclitaxel
Palbociclib oral dosing on Days 1 to 21 of each 28-day cycle. Nab-paclitaxel IV dosing on Days -2, 6, and 13 of Cycle 1, and on Days 1, 8, and 15 of subsequent cycles.
Interventions:
  • Drug: Palbociclib
  • Drug: Nab-Paclitaxel
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
76
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
60
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion DateOctober 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United States
Removed Location CountriesSwitzerland
 
Administrative Information
NCT Number  ICMJE NCT02501902
Other Study ID Numbers  ICMJE A5481059
2015-001307-31 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Celgene
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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