Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Cancer
- Bladder Cancer
- Stage IIIC Breast Cancer
- Stage IIIB Non Small Cell Lung Cancer
- Cancer of Unknown Primary
- Stage IVA Pancreatic Cancer
- Colorectal Cancer
- Ovarian Cancer
- Sarcoma
- Solid Neoplasm
- Stage III Pancreatic Cancer
- Stage IIIA Breast Cancer
- Stage IIIA Non-Small Cell Lung Cancer
- Stage IV Breast Cancer
- Stage IVB Pancreatic Cancer
- Stage IV Non-small Cell Lung Cancer
- Stage IIIB Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Assess the safety and tolerability of palbociclib when administered along with cisplatin or carboplatin. II. Establish the recommended phase 2 dose (RP2D) of the tested combinations. SECONDARY OBJECTIVES: I. Characterize the pharmacokinetic (PK) profiles of cisplatin, carbopla...
PRIMARY OBJECTIVES: I. Assess the safety and tolerability of palbociclib when administered along with cisplatin or carboplatin. II. Establish the recommended phase 2 dose (RP2D) of the tested combinations. SECONDARY OBJECTIVES: I. Characterize the pharmacokinetic (PK) profiles of cisplatin, carboplatin. II. Obtain preliminary evidence of anti-tumor efficacy of the tested combination regimens. III. Conduct PK/pharmacodynamics (PD) correlative analyses using palbociclib trough concentration and cyclin-dependent kinase 4 (CDK4) inhibition read-outs in tumor and surrogate samples collected on course 1 day 22 (C1D22). IV. Assess potential association between tissue-based biomarkers and efficacy. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 arms. ARM A: Patients receive cisplatin intravenously (IV) over 30-60 minutes on day 1 and palbociclib orally (PO) once daily (QD) on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive carboplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for up to 4 weeks.
Tracking Information
- NCT #
- NCT02897375
- Collaborators
- Pfizer
- Investigators
- Principal Investigator: Taofeek Owonikoko, MD, PhD Emory University
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