Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

NCT02897375

Last updated date
Study Location
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Contact
404-778-4383

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Neoplasm, Stage III Pancreatic Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IV
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

- Patients must have histologically or cytologically confirmed solid organ malignancy

- Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam

- Leukocytes ≥ 3,000/mL

- Absolute neutrophil count ≥ 1,500/mL

- Platelets ≥ 100,000/mL

- Hemoglobin ≥ 10 g/dL

- Total bilirubin ≤ 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (up to 5 X upper limit of normal [ULN] for patients with liver metastasis)

- Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal

- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients who have had cytotoxic anticancer chemotherapy or immune checkpoint inhibitor
within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or palliative radiation
within 2 weeks (stereotactic radiation therapy [SRS] for brain metastasis within 48
hours) prior to entering the study or those who have not recovered from adverse events
due to agents administered more than 4 weeks earlier


- Patients receiving cytotoxic agent as immunomodulatory therapy for a non neoplastic
indication (e.g. methotrexate for rheumatoid arthritis) and who are unable to
discontinue such agents within 2 weeks prior to starting treatment


- Oral targeted therapy within five days or five half-lives, whichever is longer, prior
to initiating protocol therapy treatment


- Patients who are receiving any other investigational agents


- Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers


- Patients with symptomatic uncontrolled brain metastases are excluded; (patients with
stable treated or asymptomatic untreated brain metastasis not requiring
glucocorticoids are allowed)


- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to palbociclib, carboplatin or cisplatin


- Concurrent administration of strong inducers and inhibitors of CYP3A enzyme or CYP3A
substrates with narrow therapeutic window


- Uncontrolled intercurrent illness including, but not limited to:


- Ongoing or active infection requiring intravenous antibiotics at the time of
treatment initiation


- Symptomatic congestive heart failure (requiring hospital stay within the last 6
months)


- Myocardial infarction within the last 6 months


- Unstable angina pectoris, cardiac arrhythmia


- Psychiatric illness


- Social situations or circumstances that would limit compliance with study requirements


- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with palbociclib


- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible

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Solid Neoplasm, Stage III Pancreatic Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IVPalbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
NCT02897375
  1. Atlanta, Georgia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies
Brief Summary This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth in patients with advanced solid tumors.
Detailed 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, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Neoplasm
  • Stage III Pancreatic Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IVA Pancreatic Cancer
  • Stage IVB Pancreatic Cancer
  • Sarcoma
  • Colorectal Cancer
  • Head and Neck Cancer
  • Cancer of Unknown Primary
  • Bladder Cancer
  • Ovarian Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    Given IV
    Other Name: Paraplatin
  • Drug: Cisplatin
    Given IV
    Other Names:
    • CDDP
    • Cis-diamminedichloridoplatinum
    • Cisplatinum
    • Cismaplat
    • Neoplatin
  • Drug: Palbociclib
    Given PO
    Other Names:
    • Ibrance
    • PD-0332991
Study Arms  ICMJE
  • Experimental: Arm A (palbociclib, cisplatin)
    Patients receive cisplatin 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.
    Interventions:
    • Drug: Cisplatin
    • Drug: Palbociclib
  • Experimental: Arm B (palbociclib, carboplatin)
    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.
    Interventions:
    • Drug: Carboplatin
    • Drug: Palbociclib
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed solid organ malignancy
  • Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status ? 2
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ? 20 mm (? 2 cm) with conventional techniques or as ? 10 mm (? 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
  • Leukocytes ? 3,000/mL
  • Absolute neutrophil count ? 1,500/mL
  • Platelets ? 100,000/mL
  • Hemoglobin ? 10 g/dL
  • Total bilirubin ? 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ? 2.5 × institutional upper limit of normal (up to 5 X upper limit of normal [ULN] for patients with liver metastasis)
  • Creatinine within normal institutional limits OR creatinine clearance ? 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had cytotoxic anticancer chemotherapy or immune checkpoint inhibitor within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or palliative radiation within 2 weeks (stereotactic radiation therapy [SRS] for brain metastasis within 48 hours) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients receiving cytotoxic agent as immunomodulatory therapy for a non neoplastic indication (e.g. methotrexate for rheumatoid arthritis) and who are unable to discontinue such agents within 2 weeks prior to starting treatment
  • Oral targeted therapy within five days or five half-lives, whichever is longer, prior to initiating protocol therapy treatment
  • Patients who are receiving any other investigational agents
  • Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
  • Patients with symptomatic uncontrolled brain metastases are excluded; (patients with stable treated or asymptomatic untreated brain metastasis not requiring glucocorticoids are allowed)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib, carboplatin or cisplatin
  • Concurrent administration of strong inducers and inhibitors of CYP3A enzyme or CYP3A substrates with narrow therapeutic window
  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection requiring intravenous antibiotics at the time of treatment initiation
    • Symptomatic congestive heart failure (requiring hospital stay within the last 6 months)
    • Myocardial infarction within the last 6 months
    • Unstable angina pectoris, cardiac arrhythmia
    • Psychiatric illness
  • Social situations or circumstances that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with palbociclib
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
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: Taofeek Owonikoko, MD, PhD404-778-4383[email protected]
Contact: Suresh Ramalingam, MD404-778-4383[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02897375
Other Study ID Numbers  ICMJE IRB00089583
NCI-2016-01037 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Winship3263-16 ( Other Identifier: Emory University/Winship Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Taofeek K. Owonikoko, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Taofeek Owonikoko, MD, PhDEmory University
PRS Account Emory University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP