A Dose Escalation Study Of PF‑06939999 In Participants With Advanced Or Metastatic Solid Tumors

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NCT03854227

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Study Location
Oncology IDS Pharmacy
Nashville, Tennessee, 37232, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors, Metastatic Solid Tumors
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

- Participants who are intolerant or resistant to standard treatment for selected solid tumors

- At least one measurable lesion as defined by RECIST version 1.1

- ECOG Performance Status 0 or 1

- Adequate Bone Marrow Function

- Adequate Renal Function

- Adequate Liver Function

- Resolved acute effects of any prior therapy

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


- Known active uncontrolled or symptomatic CNS metastases.


- Major surgery, radiation therapy, systemic anti-cancer therapy or investigational
drug(s) within 4 weeks prior to study entry.


- Active, uncontrolled infection


- Known or suspected hypersensitivity to PF-06939999


- Inability to consume or absorb study drug

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Advanced Solid Tumors, Metastatic Solid TumorsA Dose Escalation Study Of PF‑06939999 In Participants With Advanced Or Metastatic Solid Tumors NCT03854227
  1. Nashville, Tennessee
  2. Scottsdale, Arizona
  3. Scottsdale, Arizona
  4. Miami, Florida
  5. Nashville, Tennessee
  6. Houston, Texas
  7. San Antonio, Texas
  8. Annandale, Virginia
  9. Fairfax, Virginia
  10. Fairfax, Virginia
  11. Seattle, Washington
  12. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Dose Escalation Study Of PF?06939999 In Participants With Advanced Or Metastatic Solid Tumors
Official Title  ICMJE A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER
Brief Summary This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Dose Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Metastatic Solid Tumors
Intervention  ICMJE
  • Drug: PF-06939999
    0.5 mg QD orally on a continuous basis
    Other Name: PRMT5 inhibitor
  • Drug: PF-06939999
    0.5 mg BID orally on a continuous basis
    Other Name: PRMT5 inhibitor
  • Drug: PF-06939999
    1 mg BID orally on a continuous basis
    Other Name: PRMT5 inhibitor
  • Drug: PF-06939999
    2 mg BID orally on a continuous basis
    Other Name: PRMT5 inhibitor
  • Drug: PF-06939999
    4 mg BID orally on a continuous basis
    Other Name: PRMT5 inhibitor
  • Drug: PF-06939999
    8 mg BID orally on a continuous basis
    Other Name: PRMT5 inhibitor
  • Drug: PF-06939999
    <=32 mg (QD or BID) orally on a continuous basis
    Other Name: PRMT5 inhibitor
  • Drug: PF-06939999
    Dose TBD (QD or BID) orally on a continuous basis
    Other Name: PRMT5 inhibitor
Study Arms  ICMJE
  • Experimental: Dose Level 1
    Participants will receive PF-06939999 at 0.5 mg once a day (QD) in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
  • Experimental: Dose Level 2
    Participants will receive PF-06939999 at 0.5 mg BID in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
  • Experimental: Dose Level 3
    Participants will receive PF-06939999 at 1 mg twice a day (BID) in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
  • Experimental: Dose Level 4
    Participants will receive PF-06939999 at 2 mg BID in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
  • Experimental: Dose Level 5
    Participants will receive PF-06939999 at 4 mg BID in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
  • Experimental: Dose Level 6
    Participants will receive PF-06939999 at 8 mg BID in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
  • Experimental: Dose Level 7
    Participants will receive PF-06939999 at <=32 mg total daily dose (QD or BID) in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
  • Experimental: Dose Level to be determined (TBD)
    Participants will receive PF-06939999 at a dose TBD (QD or BID) in 28 day cycles on a continuous basis
    Intervention: Drug: PF-06939999
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: February 22, 2019)		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 27, 2022
Estimated Primary Completion Date July 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants who are intolerant or resistant to standard treatment for selected solid tumors
  • At least one measurable lesion as defined by RECIST version 1.1
  • ECOG Performance Status 0 or 1
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function
  • Resolved acute effects of any prior therapy

Exclusion Criteria:

  • Known active uncontrolled or symptomatic CNS metastases.
  • Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry.
  • Active, uncontrolled infection
  • Known or suspected hypersensitivity to PF-06939999
  • Inability to consume or absorb study drug
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03854227
Other Study ID Numbers  ICMJE C3851001
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 February 2020

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