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A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Aichi Cancer Center Hospital
Nagoya, Aichi, 464-8681 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Phase 1

- In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically
or cytologically at original diagnosis, that is refractory to standard therapy or for
whom no standard of care therapy is available.

- In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive,
HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent
or metastatic disease (including bone only disease) not amenable to resection or
radiation therapy with curative intent and for whom chemotherapy is not clinically
indicated.

- Adequate blood cell counts, kidney function and liver function and and Eastern
Cooperative Oncology Group [ECOG] score of 0 or 1.

- Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

Phase 2

- Adult women (≥ 20 years of age) with proven diagnosis of adenocarcinoma of the breast
with evidence of locoregionally recurrent or metastatic disease not amenable to
resection or radiation therapy with curative intent and for whom chemotherapy is not
clinically indicated.

- Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast
cancer based on local laboratory results.

- Adequate blood cell counts, kidney function and liver function and and Eastern
Cooperative Oncology Group [ECOG] score of 0 to 2.

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

Phase 1

- Active uncontrolled or symptomatic CNS metastases.

- Uncontrolled infection, unstable or sever intercurrent medical condition, or current
drug or alcohol abuse

- Active or unstable cardiac disease or history of heart attack within 6 months

Phase 2

- HER2 positive tumor based on local laboratory results utilizing one of the sponsor
approved assays.

- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or
leptomeningeal disease.

- Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie,
anastrozole or letrozole) with disease recurrence while on or within 12 months of
completing treatment.

NCT01684215
Pfizer
Active, not recruiting
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

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A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
A Phase 1/2 Study Of The Efficacy, Safety, And Pharmacokinetics Of Oral Pd-0332991, A Cyclin-dependent Kinase 4 And 6 (cdk4/6) Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-line Treatment Of Postmenopausal Japanese Patients With Er (+) Her2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination with letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The Phase 2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+) HER2(-) ABC.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Neoplasms
  • Breast Neoplasms
  • Drug: PD-0332991
    PD-0332991 (100 mg or 125 mg) will be orally administered once a day for 3 weeks followed by 1 week off treatment, in the morning on an empty stomach. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
  • Drug: PD-0332991
    PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
  • Drug: letrozole
    Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.
  • Experimental: Single-agent PD-0332991
    Phase 1 Part 1
    Intervention: Drug: PD-0332991
  • Experimental: PD-0332991 in combination with letrozole
    Phase 1 Part 2
    Interventions:
    • Drug: PD-0332991
    • Drug: letrozole
  • Experimental: PD-0332991 with letrozole
    Phase 2
    Interventions:
    • Drug: PD-0332991
    • Drug: letrozole
Tamura K, Mukai H, Naito Y, Yonemori K, Kodaira M, Tanabe Y, Yamamoto N, Osera S, Sasaki M, Mori Y, Hashigaki S, Nagasawa T, Umeyama Y, Yoshino T. Phase I study of palbociclib, a cyclin-dependent kinase 4/6 inhibitor, in Japanese patients. Cancer Sci. 2016 Jun;107(6):755-63. doi: 10.1111/cas.12932. Epub 2016 May 11.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
61
June 2018
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Phase 1

  • In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.
  • In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
  • Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 or 1.
  • Resolved acute effects of any prior therapy to baseline severity or Grade ?1

Phase 2

  • Adult women (? 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
  • Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.
  • Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 to 2.

Exclusion Criteria:

Phase 1

  • Active uncontrolled or symptomatic CNS metastases.
  • Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse
  • Active or unstable cardiac disease or history of heart attack within 6 months

Phase 2

  • HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.
  • Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
  • Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01684215
A5481010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 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.

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