- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00422097
A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer
February 9, 2016 updated by: R-Pharm
A Phase I Study of Ixabepilone Administered as a Daily Oral Dose on 5 Successive Days Every 21 Days in Subjects With Advanced Cancer
This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer.
The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied.
In addition, this study will assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of oral ixabepilone.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center Lombardi Cancer Center
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University (Hwcrc)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of solid tumor malignancy unresponsive to current treatment options
- Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors
- Lapse of at least 1 week since minor surgery and of at least 3 weeks since major surgery and radiation therapy
- Eastern Cooperative Oncology Group performance status of 0-1
- Lapse of at least 4 weeks since immunotherapy or chemotherapy
- Negative pregnancy test result within 72 hours of study drug administration for any woman of childbearing potential (WOCBP)
Exclusion Criteria:
- WOCBP unable or unwilling to use birth control during study and for up to 4 weeks after study completion
- Women who are pregnant or breastfeeding
- Fertile men not using effective birth control with partners who are WOCBP
- Gastrointestinal(GI) disease or GI tract surgery that could impact drug absorption
- Inability to swallow capsules
- Inability to be venipunctured or to tolerate venous access
- Known symptomatic brain metastases
- Common Terminology Criteria for Adverse Events Grade 2 or greater neuropathy or history of Grade 3 or greater neuropathy
- Psychiatric conditions inhibiting compliance with protocol requirements
- Uncontrolled medical disorder or active infection that would impair participant's ability to receive protocol therapy or whose control may be jeopardized by the study treatment protocol
- Inadequate hematologic, hepatic, or renal function
- History of significant drug allergy
- Previous exposure to ixabepilone
- Exposure to any investigational drug or placebo within 4 weeks of enrollment
- Concurrent chemotherapy regimen
- Use of cytochrome P4503A4 inhibitors or inducers within 2 weeks of treatment initiation (unless approved by medical monitor)
- Use of steroids (except as antiemetic)
- Prisoners or subjects involuntarily detained for treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ixabepilone, 5 mg/d
If none of first 3 participants experiences a dose-limiting toxicity (DLT) during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments).
If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the maximum tolerated dose (MTD).
If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants.
If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
|
Ixabepilone, 5 mg, administered orally once daily on Days 1 through 5 every 21 days.
Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal.
No dose escalation within each treatment group.
On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
|
Experimental: Ixabepilone, 10 mg/d
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments).
If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD.
If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants.
If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
|
Ixabepilone, 10 mg, administered orally once daily on Days 1 through 5 every 21 days.
Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal.
No dose escalation within each treatment group.
On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
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Experimental: Ixabepilone, 15 mg/d
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments).
If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD.
If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants.
If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
|
Ixabepilone, 15 mg, administered orally once daily on Days 1 through 5 every 21 days.
Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal.
No dose escalation within each treatment group.
On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
|
Experimental: Ixabepilone, 20 mg/d
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments).
If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD.
If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants.
If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
|
Ixabepilone, 20 mg, administered orally once daily on Days 1 through 5 every 21 days.
Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal.
No dose escalation within each treatment group.
On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
|
Experimental: Ixabepilone, 25 mg/d
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments).
If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD.
If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants.
If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
|
Ixabepilone, 25 mg, administered orally once daily on Days 1 through 5 every 21 days.
Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal.
No dose escalation within each treatment group.
On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
|
Experimental: Ixabepilone, 30 mg/d
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments).
If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD.
If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants.
If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
|
Ixabepilone, 30 mg, administered orally once daily on Days 1 through 5 every 21 days.
Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal.
No dose escalation within each treatment group.
On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
|
Experimental: Ixabepilone, 25 mg, with famotidine
Following identification of MTD, participants who completed Cycle 1 and treated at the ixabepilone MTD (25 mg/d) will crossover to Cycle 2 in which they receive famotidine, 40 mg on Day 1.
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Participants crossed over from Cycle 1 to receive famotidine, 40 mg, in an oral dose given 2 hours before ixabepilone, 25 mg, on Day 1 of Cycle 2 only.
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Experimental: Ixabepilone, 25 mg, with food
Following identification of MTD, participants who completed Cycle 1 and treated at the ixabepilone MTD (25 mg/d) will crossover to Cycle 2 in which they receive a low-fat meal on Day 1.
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Participants consume a low-fat meal starting 30 minutes before dose administration on Day 1 of Cycle 2. Food consumed within 30 minutes.
Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD) of Ixabepilone
Time Frame: Days 1 through 21 (Cycle 1)
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MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level.
DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.
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Days 1 through 21 (Cycle 1)
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Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade
Time Frame: Days 1 through 21 (Cycle 1), continuously
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Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment.
Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.
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Days 1 through 21 (Cycle 1), continuously
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
Time Frame: Days 1 through 21 (Cycle 1), continuously
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An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment.
Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
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Days 1 through 21 (Cycle 1), continuously
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Number of Participants With Abnormal Laboratory Values by Worst CTC Grade
Time Frame: Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)
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Lower limit of normal (LLN)=lowest level of normal among all laboratory ranges.
Hemoglobin (g/dL): Gr 1: 10.0-<LLN; Gr 2: 8.0-<10.0;
Gr 3:6.5-<8.0;
Gr 4: 6.5.
Leukocytes (c/uL): Gr 1: 3.0-<LLN; Gr 2: 2.0-<3.0;
Gr 3: 1.0-<2.0;
Gr 4: <1.0.
Lymphocytes (c/uL): Gr 1: 0.8-<1.5;
Gr 2: 0.5-<0.8;
Gr 3: 0.2-<0.5;
Gr 4: <0.2.
Neutrophils (Absolute)(c/uL): Gr 1: 1.5-<2.0;
Gr 2: 1.0-<1.5;
Gr 3: 0.5-<1.0;
Gr 4: <0.5.
Neutrophils + Bands (c/uL): Gr 1: 1.5-<2.0;
Gr 2: 1.0-<1.5;
Gr 3: 0.5-<1.0;
Gr 4: <0.5.
Platelet Count (c/uL):Gr 1: 75.0-<LLN;
Gr 2: 50.0-<75.0;
Gr 3: 25.0-<50.0;
Gr 4: <25.0.
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Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)
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Maximum Plasma Concentration (Cmax) of Ixabepilone
Time Frame: Days 1 and 5 of Cycle 1
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Days 1 and 5 of Cycle 1
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Time of Maximum Plasma Concentration (Tmax) of Ixabepilone
Time Frame: Days 1 and 5 of Cycle 1
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Days 1 and 5 of Cycle 1
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Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone
Time Frame: Days 1 and 5 of Cycle 1
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Days 1 and 5 of Cycle 1
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Plasma Half-life (T-Half) of Ixabepilone
Time Frame: Day 5 of Cycle 1
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Day 5 of Cycle 1
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Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
Time Frame: Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
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After the MTD has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only.
Meal is consumed within a 30-minute period.
Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
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Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
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Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
Time Frame: Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only.
Meal is consumed within a 30-minute period.
Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
|
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
Time Frame: Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only.
Meal is consumed within a 30-minute period.
Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
|
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
Time Frame: Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg.
Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
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Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
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Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
Time Frame: Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg.
Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
|
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
Time Frame: Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given alone once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg.
Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
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Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
|
Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG)
Time Frame: At screening and predose Day 1, Cycle 1 (21 days)
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Physical examination evaluated height, weight, Eastern Cooperative Oncology Group performance status, adverse events, and abnormal laboratory findings and included a neurologic examination to evaluate deep tendon reflexes, sensory modalities, and motor strength.
Participants also underwent a 12-lead ECG screening.
Physical examination findings and ECG findings were considered clinically significant at the investigator's discretion.
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At screening and predose Day 1, Cycle 1 (21 days)
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Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels
Time Frame: At screening and predose Day 1, Cycle 1 (21 days)
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Upper limit of normal (ULN)=upper level of normal among all laboratory ranges.
Alkaline phosphatase(U/L): Gr 3: >5.0-20.0*ULN;
Gr 4: >20.0*ULN.
Sodium (mEq/L): Gr 3: 120-<130 or >155-160; Gr 4 <120.
Potassium (mEq/L): Gr 3: 2.5-<3.0 or >6.0-7.0;
Gr 4: <2.5 or >7.0.
Calcium (mg/dL): Gr 3: 6.0-<7.0 or >12.5-13.5;
Gr 4: <6.0 or >13.5.
Inorganic phosphorus (mg/dL): Gr 3: 1.0-<2.0;
Gr 4: <1.0.
Albumin (g/dL): Gr 3: <2.0.
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At screening and predose Day 1, Cycle 1 (21 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
January 12, 2007
First Submitted That Met QC Criteria
January 12, 2007
First Posted (Estimate)
January 15, 2007
Study Record Updates
Last Update Posted (Estimate)
March 10, 2016
Last Update Submitted That Met QC Criteria
February 9, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- Histamine H2 Antagonists
- Famotidine
- Epothilones
Other Study ID Numbers
- CA163-111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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