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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)

Last updated on March 31, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm
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

Cisplatin Combination Expansion:

Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic
setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the
metastatic setting.

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

- Prior therapy for Cisplatin Combination Expansion:

- Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic
setting;

- Prior radiation to >25% bone marrow as estimated by the Investigator.

- 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.

NCT01920061
Pfizer
Recruiting
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)

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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)
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
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).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Basic Science
Neoplasm
  • Drug: PF-05212384 (gedatolisib)
    PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
  • Drug: Docetaxel
    Docetaxel intravenous infusions once every 3 weeks starting at 75 mg/m^2
  • Drug: Cisplatin
    Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2
  • Drug: Dacomitinib
    Dacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg
  • Experimental: Arm A
    Interventions:
    • Drug: PF-05212384 (gedatolisib)
    • Drug: Docetaxel
  • Experimental: Arm B
    Interventions:
    • Drug: PF-05212384 (gedatolisib)
    • Drug: Cisplatin
  • Experimental: Arm C
    Interventions:
    • Drug: PF-05212384 (gedatolisib)
    • Drug: Dacomitinib
  • Experimental: Expansion Arm 1
    Interventions:
    • Drug: PF-05212384 (gedatolisib)
    • Drug: Cisplatin
  • Experimental: Expansion Arm 2
    Interventions:
    • Drug: PF-05212384 (gedatolisib)
    • Drug: Cisplatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
December 18, 2019
December 18, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Cisplatin Combination Expansion:

Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the metastatic setting.

  • 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, ovarian 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:

  • Prior therapy for Cisplatin Combination Expansion:

    • Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic setting;
    • Prior radiation to >25% bone marrow as estimated by the Investigator.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT01920061
B2151002
2013-001390-24 ( 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

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