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PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors

NCT02022982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-19

No results posted yet for this study

Summary

This research study is evaluating the experimental drug palbociclib in combination with another experimental drug PD-0325901 as a possible treatment for cancers with KRAS mutations, particularly for those which started in the lung.

Conditions

Interventions

DRUG

Palbociclib

Palbociclib will be administered orally once daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 75 mg daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for palbociclib are required. It should be administered without food with patients fasting for 1 hour prior and 2 hours post drug administration.

DRUG

PD-0325901

PD-0325901 will be administered orally twice daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 2 mg twice daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. PD-0325901 will be administered using a flat-dosing plan. No premedications are required. As the effect of food on PD-0325901 is uncertain, patients will be permitted to dose either fasting or after food.

Sponsors & Collaborators

Principal Investigators

  • Geoffrey Shapiro, MD. Ph.D · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-11-01
Completion
2021-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02022982 on ClinicalTrials.gov