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A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors

Last updated on November 15, 2018

FOR MORE INFORMATION
Study Location
Research Administration Office: Clinical Research Unit
Los Angeles, California, 90024 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
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

- Histological or cytological diagnosis of locally advanced or metastatic NSCLC or
urothelial carcinoma who have progressed on or were intolerant to standard of care
systemic therapy, or for whom standard of care systemic therapy was refused (refusal
must be documented) or unavailable.

- No prior treatment with anti-PD-1 or anti-PD-L1 therapy.

- NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have
progressed on or after no more than 1 prior line of platinum-containing systemic
therapy or were intolerant or refused standard of care systemic therapy.

- NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received
prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting
drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must
have progressed on or after both types of therapies.

- Urothelial carcinoma patients must have received up to 2 lines of prior systemic
therapy and progressed on or after, experienced disease recurrence within 12 months of
neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused
platinum-containing systemic therapy. If urothelial cancer patients are treatment
naïve and eligible for platinum-containing systemic therapy but are refusing platinum
chemotherapy, they must also be documented to have previous PD-L1 high status.

- Provide archived tumor tissue sample taken within the past 2 years or provide a fresh
tumor biopsy sample.

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

- Adequate renal, liver, thyroid and bone marrow function.

- Performance status 0 or 1.

- Patient is capable of receiving study treatment for at least 8 weeks.

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

- Active brain or leptomeningeal metastases.

- Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes
mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone
replacement, psoriasis not requiring systemic treatment, or conditions not expected to
recur in the absence of an external trigger are permitted to enroll. Diagnosis of
prior immunodeficiency or organ transplant requiring immunosuppressive therapy or
prior allogeneic bone marrow or hematopoietic stem cell transplant.

- Patients with a condition requiring systemic treatment with either corticosteroids
(>10mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of study drug administration. Inhaled or topical steroids, and adrenal
replacement doses >10 mg daily prednisone equivalents are permitted in the absence of
active autoimmune disease.

- Patients with a history of interstitial lung disease, non-infectious pneumonitis, or
active pulmonary tuberculosis. Those with active lung infections requiring treatment
are also excluded.

- History of Grade ?3 immune mediated AE (including AST/ALT elevations that where
considered drug related and cytokine release syndrome) that was considered related to
prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory
agents, etc.) and required immunosuppressive therapy.

- Active hepatitis B or C, HIV/AIDS.

- Other potentially metastatic malignancy within past 5 years.

NCT02573259
Pfizer
Recruiting
A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors

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A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
A Phase 1, Open-label, Dose Escalation And Expansion Study Of Pf-06801591 In Patients With Locally Advanced Or Metastatic Melanoma, Squamous Cell Head And Neck Cancer, Ovarian Cancer, Sarcoma, Non-small Cell Lung Cancer, Urothelial Carcinoma Or Other Solid Tumors.
Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose.

Protocol B8011001 is a Phase 1, two part, open-label, multi center, multiple-dose, safety, efficacy, PK, and PD study of PF-06801591 administered intravenously (IV) or subcutaneous (SC) in previously treated adult patients with locally advanced or metastatic melanoma, squamous cell carcinoma head and neck (SCCHN), ovarian carcinoma, sarcoma, non-small cell lung carcinoma (NSCLC), urothelial carcinoma or other solid tumors.

The first part of the study, Part 1 dose escalation, was designed to assess the safety and tolerability of increasing dose levels of IV or SC administered PF-06801591 to establish the maximum tolerated dose (MTD) using a modified Toxicity Probability Interval (mTPI) design. Part 2 expansion is designed to further evaluate the safety and efficacy of 300 mg of PF-06801591 administered SC once every 4 weeks in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose (RP2D). Part 1 enrollment has completed, enrollment will only be allowed for Part 2.

Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Part 1
  • MELANOMA
  • SCCHN
  • OVCA
  • SARCOMA
  • OTHER SOLID TUMORS
  • Part 1 and 2
  • NSCLC
  • UROTHELIAL CARCINOMA
  • Drug: PF-06801591
    IV every 21 days (Part 1)
  • Drug: PF-06801591
    300 mg SC every 28 days (Part 1 and 2)
  • Experimental: Arm 1 PF-06801591
    0.5 mg/kg IV every 21 days (Part 1)
    Intervention: Drug: PF-06801591
  • Experimental: Arm 2 PF-06801591
    1.0 mg/kg IV every 21 days (Part 1)
    Intervention: Drug: PF-06801591
  • Experimental: Arm 3 PF-06801591
    3.0 mg/kg IV every 21 days (Part 1)
    Intervention: Drug: PF-06801591
  • Experimental: Arm 4 PF-06801591
    10 mg/kg IV every 21 days (Part 1)
    Intervention: Drug: PF-06801591
  • Experimental: Arm 5 PF-06801591
    300 mg SC every 28 days (Part 1 and 2)
    Intervention: Drug: PF-06801591
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 21, 2021
May 14, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria (Part 2 Only):

  • Histological or cytological diagnosis of locally advanced or metastatic NSCLC or urothelial carcinoma who have progressed on or were intolerant to standard of care systemic therapy, or for whom standard of care systemic therapy was refused (refusal must be documented) or unavailable.
  • No prior treatment with anti-PD-1 or anti-PD-L1 therapy.
  • NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have progressed on or after no more than 1 prior line of platinum-containing systemic therapy or were intolerant or refused standard of care systemic therapy.
  • NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must have progressed on or after both types of therapies.
  • Urothelial carcinoma patients must have received up to 2 lines of prior systemic therapy and progressed on or after, experienced disease recurrence within 12 months of neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused platinum-containing systemic therapy.
  • Provide archived tumor tissue sample taken within the past 2 years or provide a fresh tumor biopsy sample.
  • At least one measurable lesion as defined by RECIST version 1.1.
  • Adequate renal, liver, thyroid and bone marrow function.
  • Performance status 0 or 1.
  • Patient is capable of receiving study treatment for at least 8 weeks.

Exclusion Criteria (Part 2 Only)

  • Active brain or leptomeningeal metastases.
  • Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy or prior allogeneic bone marrow or hematopoietic stem cell transplant.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients with a history of interstitial lung disease, non-infectious pneumonitis, or active pulmonary tuberculosis. Those with active lung infections requiring treatment are also excluded.
  • History of Grade ?3 immune mediated AE (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy.
  • Active hepatitis B or C, HIV/AIDS.
  • Other potentially metastatic malignancy within past 5 years.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02573259
B8011001
2016-003314-27 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

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1-800-718-1021

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