A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

NCT04543188

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Malignant Melanoma, Non-Small-Cell Lung Carcinoma, Primary Brain Neoplasms, Brain Neoplasms, Malignant Neoplasms
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

- Age ≥18 years at the time of consent

- Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor

- Documented evidence of a BRAF V600 mutation in tumor tissue or blood

- Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory

- Presence or absence of brain involvement unless specified below

- Dose Expansion (Part B)

- Cohort 1, 2, 3, 4: melanoma or NSCLC with at least 1 parenchymal brain lesion

- Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment

- Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment

- Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.

- Cohort 6 (DDI Sub-study): if brain involvement present, must be asymptomatic

- Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below

- Dose Expansion (Part B)

- Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment

- Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

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


- Brain metastasis/primary brain tumor requiring immediate local intervention


- History of or current leptomeningeal metastases


- Any other active malignancy within 2 years prior to enrollment


- Radiation therapy to visceral metastases within 14 days prior to study treatment. WBRT
within 28 days prior to study treatment.


- Systemic anti-cancer therapy or small-molecular therapeutic(s) within 2 weeks prior to
start of study treatment; Antibody based agents within 4 weeks prior to start of study
treatment.


- History or current evidence of RVO or current risk factors for RVO; History of retinal
degenerative disease

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Malignant Melanoma, Non-Small-Cell Lung Carcinoma, Primary Brain Neoplasms, Brain Neoplasms, Malignant NeoplasmsA FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
NCT04543188
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
Official Title  ICMJE A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF 07284890 (ARRY 461) IN PARTICIPANTS WITH BRAF V600 MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT
Brief Summary First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced solid tumor malignancies with and without brain involvement.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Melanoma
  • Carcinoma, Non-Small-Cell Lung
  • Brain Neoplasms, Primary
  • Brain Neoplasms
  • Malignant Neoplasms
Intervention  ICMJE
  • Drug: PF-07284890
    PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
    Other Name: ARRY-461
  • Drug: Binimetinib
    Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
    Other Name: Mektovi
  • Drug: Midazolam
    Midazolam will be administered 7 days before start of study drug, on Cycle 1 Day 1, and on Cycle 1 Day 15
Study Arms  ICMJE
  • Experimental: PF-07284890 (Part A monotherapy)
    Monotherapy dose escalation of PF-07284890
    Intervention: Drug: PF-07284890
  • Experimental: PF-07284890+binimetinib (Part A combo-therapy)
    Combination dose escalation of PF-07284890 + binimetinib
    Interventions:
    • Drug: PF-07284890
    • Drug: Binimetinib
  • Experimental: Expansion Phase (Part B, Cohort 1)
    PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma or Non-Small Cell Lung Cancer (NSCLC), with asymptomatic brain involvement, and no prior BRAF or MEK inhibitor utilization
    Interventions:
    • Drug: PF-07284890
    • Drug: Binimetinib
  • Experimental: Expansion Phase (Part B, Cohort 2)
    PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma or NSCLC, with symptomatic brain involvement, and no prior BRAF or MEK inhibitor utilization
    Interventions:
    • Drug: PF-07284890
    • Drug: Binimetinib
  • Experimental: Expansion Phase (Part B, Cohort 3)
    PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma or NSCLC, with asymptomatic brain involvement, and prior BRAF inhibitor utilization
    Interventions:
    • Drug: PF-07284890
    • Drug: Binimetinib
  • Experimental: Expansion Phase (Part B, Cohort 4)
    PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma or NSCLC, with symptomatic brain involvement, and prior BRAF inhibitor utilization
    Interventions:
    • Drug: PF-07284890
    • Drug: Binimetinib
  • Experimental: Expansion Phase (Part B Cohort 5)
    PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 solid tumor; history of or current leptomeningeal metastases; without disease in the brain; with disease in the brain that does not meet Cohorts 1-4; asymptomatic or symptomatic in the brain; primary brain tumors
    Interventions:
    • Drug: PF-07284890
    • Drug: Binimetinib
  • Experimental: Drug-Drug Interaction Substudy
    PF-07284890 (at recommended dose from Part A) plus binimetinib plus midazolam in participants with BRAF V600 solid tumor
    Interventions:
    • Drug: PF-07284890
    • Drug: Binimetinib
    • Drug: Midazolam
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2020)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 10, 2023
Estimated Primary Completion Date May 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ?18 years at the time of consent
  • Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor
  • Documented evidence of a BRAF V600 mutation in tumor tissue or blood
  • Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory
  • Presence or absence of brain involvement unless specified below
  • Dose Expansion (Part B)

    • Cohort 1, 2, 3, 4: melanoma or NSCLC with at least 1 parenchymal brain lesion
    • Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment
    • Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment
    • Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.
    • Cohort 6 (DDI Sub-study): if brain involvement present, must be asymptomatic
  • Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below
  • Dose Expansion (Part B)

    • Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment
    • Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Brain metastasis/primary brain tumor requiring immediate local intervention
  • History of or current leptomeningeal metastases
  • Any other active malignancy within 2 years prior to enrollment
  • Radiation therapy to visceral metastases within 14 days prior to study treatment. WBRT within 28 days prior to study treatment.
  • Systemic anti-cancer therapy or small-molecular therapeutic(s) within 2 weeks prior to start of study treatment; Antibody based agents within 4 weeks prior to start of study treatment.
  • History or current evidence of RVO or current risk factors for RVO; History of retinal degenerative disease
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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04543188
Other Study ID Numbers  ICMJE C4471001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

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