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A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

NCT01920061

Description:

This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Bladder Carcinoma
  • Breast Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Prostate Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

A Study Of <span class="go-doc-concept go-doc-intervention">PF-05212384</span> In Combination With Other Anti-Tumor Agents

Title

  • Brief Title: A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents
  • Official Title: A Phase 1b Open-label Three-arm Multi-center Study To Assess The Safety And Tolerability Of Pf-05212384 (pi3k/Mtor Inhibitor) In Combination With Other Anti-tumor Agents
  • Clinical Trial IDs

    NCT ID: NCT01920061

    ORG ID: B2151002

    NCI ID: 2013-001390-24

    Trial Conditions

    Neoplasm

    Trial Interventions

    Drug Synonyms Arms
    PF-05212384 Arm A
    Docetaxel Arm A
    PF-05212384 Arm B
    Cisplatin Arm B
    PF-05212384 Arm C
    Dacomitinib Arm C

    Trial Purpose

    This study will evaluate PF-05212384 (PI3K/mTOR inhibitor) in combination with either
    docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess
    the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with
    advanced cancer in order to determine the maximum tolerated dose in each combination.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A Experimental PF-05212384, Docetaxel
    Arm B Experimental PF-05212384, Cisplatin
    Arm C Experimental PF-05212384, Dacomitinib

    Eligibility Criteria

    Inclusion Criteria:

    - Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell
    lunch cancer that are candidates for treatment with a docetaxel-based combination.

    - Arm B: Urothelial transitional cell cancer, triple negative breast cancer, or non
    small cell lunch cancer that are candidates for a cisplatin-based combination.

    - Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+
    esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch
    cancer that are candidates for treatment with a dacomitinib-based combination.

    - Availability of archival tumor biopsy sample or willing to provide fresh biopsy if
    not available.

    - Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.

    - Adequate bone marrow, renal and liver function.

    Exclusion Criteria:

    - Patients with known symptomatic brain metastases.

    - Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the
    lead-in dose.

    - Major surgery within 4 weeks of the baseline disease assessments.

    - >2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.

    - Active bacterial, fungal or viral infection.

    - Uncontrolled or significant cardiovascular disease.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of participants with Dose-limiting toxicities (DLT)

    Secondary Outcome Measures

    Maximum Observed Plasma Concentration (Cmax)

    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Gene sequence data

    QTc interval

    Objective tumor response

    Levels of PI3K pathway protein biomarkers

    Trial Keywords

    Advanced cancer

    solid tumors

    PI3K

    mTOR

    PI3K/mTOR

    metastatic