Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01037790
Collaborator
(none)
304
1
5
120
2.5

Study Details

Study Description

Brief Summary

RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the response rates following treatment with PD 0332991 in the following malignancies: 1) Metastatic breast cancer, 2) Metastatic colorectal cancer, 3) Metastatic melanoma with CDK4 mutation or amplification, or 4) Cisplatin-refractory, unresectable germ cell tumors.
OUTLINE:

Patients receive oral PD 0332991 once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

Study Design

Study Type:
Interventional
Actual Enrollment :
304 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1 - Metastatic breast cancer

Metastatic breast cancer PD-0332991 Given orally, 125 mg QD on a 21-day

Drug: PD-0332991
Given orally, 125 mg QD on a 21-day
Other Names:
  • Palbociclib
  • Experimental: Arm 2 - Metastatic colorectal cancer that harbors the Kras or BRAF mutation

    Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991 Given orally, 125 mg QD on a 21-day

    Drug: PD-0332991
    Given orally, 125 mg QD on a 21-day
    Other Names:
  • Palbociclib
  • Experimental: Arm 3 - Advanced or metastatic esophageal and/or gastric cancer

    Advanced or metastatic esophageal and/or gastric cancer PD-0332991 Given orally, 125 mg QD on a 21-day

    Drug: PD-0332991
    Given orally, 125 mg QD on a 21-day
    Other Names:
  • Palbociclib
  • Experimental: Arm 4 - Cisplatin-refractory, unresectable germ cell tumors

    Cisplatin-refractory, unresectable germ cell tumors PD-0332991 Given orally, 125 mg QD on a 21-day

    Drug: PD-0332991
    Given orally, 125 mg QD on a 21-day
    Other Names:
  • Palbociclib
  • Experimental: Arm 5 - CCND1amplification, CDK4/6mutation, CCND2amplification, OR other functional G1/S alterations

    Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991 Given orally, 125 mg QD on a 21-day

    Drug: PD-0332991
    Given orally, 125 mg QD on a 21-day
    Other Names:
  • Palbociclib
  • Outcome Measures

    Primary Outcome Measures

    1. Response Rates [10 years]

      Response rates will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) - Disappearance of all target lesions Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline Progressive Disease (PD) - ≥20% increase in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded since treatment started OR The appearance of 1 or more new lesions Stable Disease (SD) - Neither PR or PD Not Evaluable (NE)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Disease Characteristics:

    All Subjects: All subjects treated under this protocol will have histologically documented cancer of one of the following types:

    1. Metastatic breast cancer (7 triple negative, 23 ER+ after the first 15 patients are enrolled on the non-CCND1cohort; in addition 10 HER2+ for combination trastuzumab and PD0332991 therapy) up to 55 total enrollment slots B. Metastatic colorectal cancer that harbors the Kras or BRAF mutation (15-30 enrollment slots) C. Advanced or metastatic esophageal and/or gastric cancer (15-30 enrollment slots) D. Cisplatin-refractory, unresectable germ cell tumors (15-30 enrollment slots) E. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint. (15-30 enrollment slots)
    • Biopsy Requirements: For Subjects with accessible disease amenable to biopsy: A biopsy will be obtained pre-treatment and in during cycle 1 (while patient is receiving drug) for molecular markers of the cell cycle, and its inhibition.

    • Subjects will be > 18 years old

    • The subject has disease that is assessable by tumor marker, physical, or radiologic means.

    • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    • The subject has adequate organ function, defined as follows A. Bilirubin ≤ 1.5 x the upper limit of normal (ULN) B. Serum creatinine ≤ 1.5 x UNL or calculated creatinine clearance ≥ 60 mL/min, and C. For subjects without liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN D. For subjects with liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase ≤ 5 x ULN

    • All tumors must test positive for Rb expression except:

    1. ER positive metastatic breast tumors (data now shows all to be Rb positive.) B. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
    • The subject has adequate marrow function, defined as follows: A. Absolute neutrophil count (ANC) >1500/mm3 B. Platelets >100,000/mm3, and C. Hemoglobin > 9 g/dL

    • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.

    • Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for 3 months after the last dose of protocol drug(s).

    • Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months.

    • However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, or ovarian suppression.

    Exclusion Criteria

    • The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of PD 0332991. . Patients with HER2-overexpressing tumors may receive trastuzumab up to the date of starting therapy, and may continue to receive trastuzumab while receiving PD0332991.

    • The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.

    • The subject has not recovered from clinically-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade ≤ 1), with the exception of neurotoxicity and alopecia.

    • The subject has untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease unless the subject has a teratoma in which case s/he may be eligible if all other eligibility criteria are met

    • The subject has uncontrolled intercurrent illness including, but not limited to:

    1. ongoing or active infection

    2. diabetes mellitus

    3. hypertension

    4. symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months

    • The subject has a baseline corrected QT interval (QTc) > 470 ms.

    • The subject is pregnant or breastfeeding.

    • The subject is known to be positive for the human immunodeficiency virus (HIV). Note:

    baseline HIV screening is not required

    • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania

    Investigators

    • Principal Investigator: Peter ODwyer, Abramson Cancer Center of the University of Pennsylvania

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Abramson Cancer Center of the University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT01037790
    Other Study ID Numbers:
    • UPCC 03909
    First Posted:
    Dec 23, 2009
    Last Update Posted:
    Mar 11, 2021
    Last Verified:
    Feb 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Arm/Group Description Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991: Given orally, 125 mg QD on a 21-day
    Period Title: Overall Study
    STARTED 63 18 19 30 11
    COMPLETED 63 18 19 30 11
    NOT COMPLETED 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Arm 5 Total
    Arm/Group Description Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991: Given orally, 125 mg QD on a 21-day Total of all reporting groups
    Overall Participants 63 18 19 30 11 141
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    1
    3.3%
    0
    0%
    1
    0.7%
    Between 18 and 65 years
    48
    76.2%
    10
    55.6%
    11
    57.9%
    29
    96.7%
    11
    100%
    109
    77.3%
    >=65 years
    15
    23.8%
    8
    44.4%
    8
    42.1%
    0
    0%
    0
    0%
    31
    22%
    Sex: Female, Male (Count of Participants)
    Female
    63
    100%
    8
    44.4%
    4
    21.1%
    4
    13.3%
    9
    81.8%
    88
    62.4%
    Male
    0
    0%
    10
    55.6%
    15
    78.9%
    26
    86.7%
    2
    18.2%
    53
    37.6%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black
    3
    4.8%
    1
    5.6%
    1
    5.3%
    3
    10%
    0
    0%
    8
    5.7%
    Other
    2
    3.2%
    1
    5.6%
    0
    0%
    4
    13.3%
    0
    0%
    7
    5%
    White
    58
    92.1%
    16
    88.9%
    18
    94.7%
    23
    76.7%
    11
    100%
    126
    89.4%
    Region of Enrollment (participants) [Number]
    United States
    63
    100%
    18
    100%
    19
    100%
    30
    100%
    11
    100%
    141
    100%

    Outcome Measures

    1. Primary Outcome
    Title Response Rates
    Description Response rates will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) - Disappearance of all target lesions Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline Progressive Disease (PD) - ≥20% increase in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded since treatment started OR The appearance of 1 or more new lesions Stable Disease (SD) - Neither PR or PD Not Evaluable (NE)
    Time Frame 10 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Arm/Group Description Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991: Given orally, 125 mg QD on a 21-day
    Measure Participants 63 18 19 30 11
    partial response
    4
    6.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    stable disease
    32
    50.8%
    6
    33.3%
    6
    31.6%
    17
    56.7%
    3
    27.3%
    progressive disease
    25
    39.7%
    8
    44.4%
    4
    21.1%
    9
    30%
    7
    63.6%
    not evaluable for response
    2
    3.2%
    4
    22.2%
    9
    47.4%
    4
    13.3%
    1
    9.1%

    Adverse Events

    Time Frame 10years
    Adverse Event Reporting Description
    Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Arm/Group Description Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991: Given orally, 125 mg QD on a 21-day
    All Cause Mortality
    Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/63 (0%) 0/18 (0%) 1/19 (5.3%) 0/30 (0%) 1/11 (9.1%)
    Serious Adverse Events
    Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/63 (1.6%) 10/18 (55.6%) 11/19 (57.9%) 10/30 (33.3%) 4/11 (36.4%)
    Blood and lymphatic system disorders
    anemia 1/63 (1.6%) 1 0/18 (0%) 0 5/19 (26.3%) 5 0/30 (0%) 0 0/11 (0%) 0
    thromboembolic event 0/63 (0%) 0 2/18 (11.1%) 2 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Gastrointestinal disorders
    bowel obstruction 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    diarrhea 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    GI bleed 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    mucositis 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    General disorders
    fever 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Investigations
    elevated alk phos 0/63 (0%) 0 2/18 (11.1%) 2 3/19 (15.8%) 3 0/30 (0%) 0 1/11 (9.1%) 1
    elavated ALT 0/63 (0%) 0 2/18 (11.1%) 2 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    elevated AST 0/63 (0%) 0 2/18 (11.1%) 2 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    leukopenia 0/63 (0%) 0 5/18 (27.8%) 5 4/19 (21.1%) 4 10/30 (33.3%) 10 0/11 (0%) 0
    lymphopenia 0/63 (0%) 0 0/18 (0%) 0 6/19 (31.6%) 6 0/30 (0%) 0 1/11 (9.1%) 1
    neutropenia 0/63 (0%) 0 6/18 (33.3%) 6 6/19 (31.6%) 6 10/30 (33.3%) 10 2/11 (18.2%) 2
    thrombocytopenia 0/63 (0%) 0 1/18 (5.6%) 1 2/19 (10.5%) 2 5/30 (16.7%) 5 2/11 (18.2%) 2
    Nervous system disorders
    nausea 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    Psychiatric disorders
    confusion 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    Other (Not Including Serious) Adverse Events
    Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/63 (63.5%) 18/18 (100%) 19/19 (100%) 25/30 (83.3%) 11/11 (100%)
    Blood and lymphatic system disorders
    anemia 34/63 (54%) 34 10/18 (55.6%) 10 7/19 (36.8%) 7 7/30 (23.3%) 7 5/11 (45.5%) 5
    thromboembolic event 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Ear and labyrinth disorders
    tinnitus 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    Eye disorders
    blurred vision 2/63 (3.2%) 2 0/18 (0%) 0 2/19 (10.5%) 2 0/30 (0%) 0 0/11 (0%) 0
    burning eyes 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    dry eyes 1/63 (1.6%) 1 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Gastrointestinal disorders
    belching 2/63 (3.2%) 2 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    bloating 1/63 (1.6%) 1 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    bowel obstruction 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    constipation 5/63 (7.9%) 5 0/18 (0%) 0 1/19 (5.3%) 1 1/30 (3.3%) 1 1/11 (9.1%) 1
    diarrhea 13/63 (20.6%) 13 2/18 (11.1%) 2 4/19 (21.1%) 4 3/30 (10%) 3 1/11 (9.1%) 1
    dry mouth 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    dyspepsia 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    early satiety 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    esophagitis 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    epigastric discomfort 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    flatulence 4/63 (6.3%) 4 1/18 (5.6%) 1 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    GERD 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    GI bleed 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    heartburn 5/63 (7.9%) 5 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    hiccups 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    Indigestion 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    mouth sensitivity 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 2/30 (6.7%) 2 0/11 (0%) 0
    mucositis 7/63 (11.1%) 7 1/18 (5.6%) 1 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    vomiting 0/63 (0%) 0 3/18 (16.7%) 3 4/19 (21.1%) 4 3/30 (10%) 3 2/11 (18.2%) 2
    General disorders
    aches 9/63 (14.3%) 9 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    arthalgia 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 2/30 (6.7%) 2 1/11 (9.1%) 1
    fatigue 28/63 (44.4%) 28 8/18 (44.4%) 8 9/19 (47.4%) 9 9/30 (30%) 9 2/11 (18.2%) 2
    fever 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    liver pain 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    lower extemity edema 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    myalgia 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 1/11 (9.1%) 1
    neck pain 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    Immune system disorders
    seasonal allergies 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Infections and infestations
    bruising 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    bladder infection 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    flu 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    pneumonia 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    sinus infection 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    urinary tract infection 2/63 (3.2%) 2 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 2/11 (18.2%) 2
    viral infection 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Investigations
    elevated alk phos 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    elavated ALT 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 2/30 (6.7%) 2 0/11 (0%) 0
    elevated AST 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 2/30 (6.7%) 2 0/11 (0%) 0
    elevated creatinine 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 2/11 (18.2%) 2
    hyperbilirubinemia 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    leukopenia 17/63 (27%) 17 0/18 (0%) 0 9/19 (47.4%) 9 11/30 (36.7%) 11 2/11 (18.2%) 2
    lymphopenia 10/63 (15.9%) 10 2/18 (11.1%) 2 1/19 (5.3%) 1 0/30 (0%) 0 1/11 (9.1%) 1
    neutropenia 18/63 (28.6%) 18 6/18 (33.3%) 6 7/19 (36.8%) 7 9/30 (30%) 9 1/11 (9.1%) 1
    thrombocytopenia 26/63 (41.3%) 26 10/18 (55.6%) 10 9/19 (47.4%) 9 9/30 (30%) 9 6/11 (54.5%) 6
    weight loss 1/63 (1.6%) 1 5/18 (27.8%) 5 0/19 (0%) 0 2/30 (6.7%) 2 0/11 (0%) 0
    Metabolism and nutrition disorders
    anorexia 7/63 (11.1%) 7 4/18 (22.2%) 4 5/19 (26.3%) 5 3/30 (10%) 3 0/11 (0%) 0
    dehydration 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    Musculoskeletal and connective tissue disorders
    joint stiffness 3/63 (4.8%) 3 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Nervous system disorders
    dysguesia 0/63 (0%) 0 0/18 (0%) 0 2/19 (10.5%) 2 0/30 (0%) 0 0/11 (0%) 0
    headache 4/63 (6.3%) 4 0/18 (0%) 0 1/19 (5.3%) 1 3/30 (10%) 3 0/11 (0%) 0
    lightheadedness 0/63 (0%) 0 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    nausea 9/63 (14.3%) 9 7/18 (38.9%) 7 4/19 (21.1%) 4 4/30 (13.3%) 4 2/11 (18.2%) 2
    neuropathy 2/63 (3.2%) 2 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    nipple sensitivity 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    orthostasis 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    unsteady gait 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    vertigo 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    Psychiatric disorders
    confusion 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    cough 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    epistaxis 1/63 (1.6%) 1 1/18 (5.6%) 1 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    hoarseness 0/63 (0%) 0 1/18 (5.6%) 1 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    shortness of breath 2/63 (3.2%) 2 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    sore throat 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    wheezing 0/63 (0%) 0 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    Skin and subcutaneous tissue disorders
    acne 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    alopecia 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 1/30 (3.3%) 1 0/11 (0%) 0
    dry skin 2/63 (3.2%) 2 0/18 (0%) 0 0/19 (0%) 0 0/30 (0%) 0 0/11 (0%) 0
    night sweats 0/63 (0%) 0 0/18 (0%) 0 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0
    pruritis 1/63 (1.6%) 1 0/18 (0%) 0 0/19 (0%) 0 2/30 (6.7%) 2 0/11 (0%) 0
    rash 3/63 (4.8%) 3 0/18 (0%) 0 1/19 (5.3%) 1 3/30 (10%) 3 0/11 (0%) 0
    Vascular disorders
    hypotension 0/63 (0%) 0 2/18 (11.1%) 2 1/19 (5.3%) 1 0/30 (0%) 0 0/11 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Jennifer Louie, Program Manager
    Organization University of Pennsylvania
    Phone 267-414-6179
    Email Jennifer.Louie2@pennmedicine.upenn.edu
    Responsible Party:
    Abramson Cancer Center of the University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT01037790
    Other Study ID Numbers:
    • UPCC 03909
    First Posted:
    Dec 23, 2009
    Last Update Posted:
    Mar 11, 2021
    Last Verified:
    Feb 1, 2021