Clinical Trials /

PF-06671008 Dose Escalation Study in Advanced Solid Tumors

NCT02659631

Description:

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin expression. The study will then expand to look at the selected dose in patients with P-cadherin expressing TNBC, CRC or NSCLC.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

PF-06671008 Dose Escalation Study in Advanced Solid Tumors

Title

  • Brief Title: PF-06671008 Dose Escalation Study in Advanced Solid Tumors
  • Official Title: A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of PF-06671008 In Patients With Advanced Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT02659631

    ORG ID: B7831001

    Trial Conditions

    Neoplasms

    Trial Interventions

    Drug Synonyms Arms
    PF-06671008 PF-06671008
    PF-06671008 PF-06671008

    Trial Purpose

    The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing
    doses of PF-06671008 in patients with advanced solid tumors with the potential to have
    P-cadherin expression. The study will then expand to look at the selected dose in patients
    with P-cadherin expressing TNBC, CRC or NSCLC.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    PF-06671008 Experimental PF-06671008, PF-06671008

    Eligibility Criteria

    Inclusion Criteria

    - Diagnosis of tumor type with the potential to have P-cadherin expression that is
    resistant to standard therapy or for which no standard therapy is available

    - Performance status of 0 or 1

    - Adequate bone marrow, kidney and liver function

    Exclusion Criteria

    - Known CNS disease including, but not limited to, metastases

    - Current or history of seizure disorder

    - History of or active autoimmune disorders

    - Active bacterial, fungal or viral infection

    - Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study
    treatment

    - Requirement for systemic immune suppressive medication

    - Grade 2 or greater peripheral neuropathy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of participants with Dose-Limiting Toxicities (DLT) [Part 1]

    Number of participants with objective response

    Secondary Outcome Measures

    Maximum Observed Plasma Concentration (Cmax)

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Plasma Decay Half-Life (t1/2)

    Area Under the Curve from Time Zero to End of Dosing Interval (AUCtacu)

    Area Under the Curve from time zero to infinity (AUCinf)

    Systemic Clearance

    Number of participants with objective response (Part 1)

    Number of participants with PFS (Part 2)

    Number of participants with OS (Part 2)

    Trial Keywords

    P-cadherin

    PF-06671008

    solid tumors

    lung cancer

    breast cancer

    colorectal cancer

    NSCLC

    TNBC

    CRC

    neoplasms

    Triple negative breast cancer

    Non-small cell lung cancer