Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy
NCT02334527
ABOUT THIS STUDY
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- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2 (see section 11.1, Appendix A)
- Histologically confirmed UC of the bladder, urethra, ureter or renal pelvis with Rb+/CDKN2A- based on immunohistochemistry (IHC) of tissue blocks or unstained slides performed within a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory at University of North Carolina (UNC); if stage I of original cohort indicates futility, molecular requirement for eligibility will change to Rb+/CCND1 overexpression (also based on IHC); see statistical section, section 8.0)
- Metastatic disease that is not amenable to curative surgery or radiation
- Prior treatment with ≤ two prior cytotoxic regimens; prior therapy must have consisted of at least one of the following: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine. If the only prior cytotoxic therapy was administered in the perioperative i.e. neoadjuvant or adjuvant settings, patient is eligible provided the interval from end of therapy to the diagnosis of metastatic disease is less than one year.
- Progressive disease during or after treatment with at least one of the agents listed above
- At least one measurable disease site (as defined by Response Evaluation Criteria In Solid Tumors (RECIST)1.1) that has not been previously irradiated
- No prior therapy with a CDK 4/6 inhibitor; prior anti PD-1 and anti PD-L1 therapy is permitted
- Washout period should be at least 2 weeks for prior chemotherapy or radiation therapy 3.1.10 Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, surgery to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE)v4 except neuropathy which may be ≤ grade 2
- No active brain metastases
- Adequate bone marrow, liver and renal functions as assessed by the following:
- Hemoglobin ≥ 8 g/dL;
- Absolute neutrophil count ≥ 1,500/uL;
- Platelets ≥ 75,000 g/uL;
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN);
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN;
- serum creatinine ≤ 2.5 times ULN;
- Negative serum pregnancy test in women of child-bearing potential within 7 days of D1 of treatment
- If fertile, agree to use effective contraception (condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during trial
- Life expectancy greater than 3 months
- Subject must be able to give written Institutional Review Board (IRB) approved informed consent and be able to follow protocol requirements
- Any prior treatment with any investigational drug within the preceding 4 weeks
- Any concurrent active malignancy requiring treatment (other than basal or squamous
cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder
tumors, other malignancies curatively treated > 3 years prior to study entry) or
patients with adenocarcinoma of the prostate that has been surgically treated and with
a post-treatment prostate-specific antigen (PSA) that is non-detectable.
- Unstable systemic disease or active uncontrolled infection
- Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to
study entry
- Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, Seville
oranges, pomelos, and exotic citrus fruits from 7 days prior to the dose of study
medication and during the entire study due to potential CYP3A4 interaction with the
study medication. Orange juice is allowed.
- Intake of any herbal preparations or medications (including, but not limited to, Saint
John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to first
dose of study drug
- Unable or unwilling to discontinue use of any drug known to be a strong or moderate
inhibitor or inducer of CYP3A4 (prohibited inducers and inhibitors must be
discontinued within 2 weeks prior to first dose of study drug; see section 11.2
Appendix B); unable or unwilling to discontinue use of any proton pump inhibitor; see
section 11.2, Appendix B
- Any malabsorption problem that, in the investigator's opinion, would prevent adequate
absorption of the study drug
- Inability to swallow oral medications
- Pregnant or breast-feeding
- Substance abuse, or medical, psychological or social conditions that may interfere
with the patient's participation in the study or the evaluation of the study results
- Other serious, ongoing, non-malignant disease or infection that would compromise
protocol objectives
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Descriptive Information | ||||
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Brief Title ICMJE | Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy | |||
Official Title ICMJE | Phase II Trial of Palbociclib (PD-0332991) in Patients With Metastatic Urothelial Cancer (UC) After Failure of First-Line Chemotherapy | |||
Brief Summary | This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of first-line chemotherapy. | |||
Detailed Description | This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of first-line chemotherapy. The study will enroll up to 40 patients to identify 36 evaluable patients, using a Simon's two-stage design, with a primary endpoint of progression free survival (PFS) at 4 months (PFS4). Secondary objectives include estimating median PFS, overall survival (OS), response rate (RR) and exploratory objectives include an evaluation of molecular predictors of response and resistance. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Metastatic Urothelial Carcinoma (UC) | |||
Intervention ICMJE | Drug: Palbociclib
125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off. Other Name: PD-0332991 | |||
Study Arms ICMJE | Palbociclib Single Arm trial
Palbociclib Intervention: Drug: Palbociclib | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 12 | |||
Original Estimated Enrollment ICMJE | 40 | |||
Actual Study Completion Date ICMJE | September 28, 2017 | |||
Actual Primary Completion Date | December 2, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02334527 | |||
Other Study ID Numbers ICMJE | LCCC 1406 14-2196 ( Other Identifier: UNC IRB ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | UNC Lineberger Comprehensive Cancer Center | |||
Study Sponsor ICMJE | UNC Lineberger Comprehensive Cancer Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | UNC Lineberger Comprehensive Cancer Center | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |