A Study Of PD-0332991 (Cyclin Dependent Kinase 4/6 Inhibitor) In Japanese Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01684215
First received: September 10, 2012
Last updated: June 17, 2013
Last verified: June 2013
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Purpose
This is a non-randomized, single country, open label, Phase 1 clinical trial which will evaluate the tolerability, safety and PK profile of PD-0332991 in Japanese patients with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Breast Neoplasms |
Drug: PD-0332991 Drug: PD-0332991 plus letrozole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study Of The Safety And Pharmacokinetics Of Oral PD-0332991, A Cyclin-Dependent Kinase 4 And 6 (CDK4/6) Inhibitor, In Japanese Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Letrozole
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- First cycle Dose Limiting Toxicities [ Time Frame: 28 days after first dose ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Area under the plasma concentration versus time curve (AUC) of PD-0332991 [ Time Frame: Cycle 1 Day -7; Cycle 1 Day 8 ] [ Designated as safety issue: No ]
- Peak Plasma Concentration of PD-0332991 [ Time Frame: Cycle 1 Day -7; Cycle 1 Day 8 ] [ Designated as safety issue: No ]
- Time for Cmax of PD-0332991 [ Time Frame: Cycle 1 Day -7;Cycle 1 Day 8 ] [ Designated as safety issue: No ]
- Terminal Elimination Half-life of PD-0332991 [ Time Frame: Cycle 1 Day -7 ] [ Designated as safety issue: No ]
- Ctrouth of PD-0332991 [ Time Frame: Day 15 of Cycle 1 and Cycle 2 ] [ Designated as safety issue: No ]
- Ctrough of letrozole [ Time Frame: Day 15 of Cycle 1 and 2, and Day 1 of Cycle 2 and Cycle 3 ] [ Designated as safety issue: No ]
- Objective tumor response [ Time Frame: Baseline and every 8 weeks ] [ Designated as safety issue: No ]
- Time to event endpoints: Duration of Response (DR) [ Time Frame: Baseline and every 8 weeks ] [ Designated as safety issue: No ]
- Time to event endpoints: Progression free survival (PFS) [ Time Frame: Baseline and every 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PD-0332991 |
Drug: PD-0332991
Formulation: PD-0332991 capsules Strength: 25 mg and 100 mg PD-0332991 will be orally administered once a day for 3 weeks followed by 1 week off treatment, in the morning on an empty stomach.
Drug: PD-0332991 plus letrozole
Formulation: PD-0332991 capsules Strength: 25 mg and 100 mg PD-0332991 will be orally administered once a day for 3 weeks followed by 1 week off treatment, in the morning on an empty stomach. PD-0332991 will be administered once a day together with letrozole. Formulation: letrozole tablets Strength: 2.5 mg Letrozole will be orally administered once a day in continuous daily dosing. |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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, 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684215
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Japan | |
| Pfizer Investigational Site | Recruiting |
| Kashiwa, Chiba, Japan | |
| Pfizer Investigational Site | Recruiting |
| Chuo-Ku, Tokyo, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01684215 History of Changes |
| Other Study ID Numbers: | A5481010 |
| Study First Received: | September 10, 2012 |
| Last Updated: | June 17, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Pfizer:
|
Phase 1 study PD-0332991 Cyclin Dependant Kinase 4/6 inhibitor |
Japanese solid tumors breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Letrozole |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013