AzTrials
AzTrials

Nausea and Vomiting, Chemotherapy-InducedPhase 1NCT00440128

The Effects Of GW679769 (Casopitant) On The Pharmacokinetics Of Docetaxel In Subjects With Cancer

A Phase 1 study testing Docetaxel and Casopitant/Docetaxel in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the effect of the study drug (GW679769) on a commonly used chemotherapy drug (docetaxel) which will be given I.V. Blood samples will be taken to see if the GW679769 alters the blood levels of the chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel and Casopitant/Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesUnited States
Study dates
4 May 2007to 17 Jul 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female
  • 18 years of age
  • A female is eligible to enter and participate in this study if she is of:
  • Non-child-bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had at least one of the following:
  • Has had a hysterectomy, or
  • Has had a bilateral oophorectomy (ovariectomy), or
Show all 19Show fewer
  • Has had a bilateral tubal ligation, or • Is considered post-menopausal (defined as amenorrheic for ≥ 1 year) and having serum follicle stimulating hormone (FSH) and serum estradiol concentrations consistent with post-menopausal status.
  • Childbearing potential, has a negative serum pregnancy or negative urine pregnancy test within 24 hours prior to administration of the first dose of study medication and agrees to one of the following:
  • Complete abstinence from sexual intercourse from two weeks prior to administration of the first dose of investigational product until 30 days after the final dose of study medication.
  • Use double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm) from two weeks prior to administration of the first dose of investigational product until 30 days after the final dose of study medication.
  • Vasectomized partner who has been documented to be sterile prior to the female subject's entry and is the sole sexual partner for that female.
  • NOTE: if women of childbearing potential are enrolled, they must use double-barrier contraception in addition to oral contraceptives during the active study treatment period until 6 weeks after the final dose of study medication.
  • Histologically confirmed malignant solid tumor and is scheduled to receive at least 2 courses of chemotherapy with docetaxel as a single intravenous dose of 20 to 40 mg/m2 given over a duration of one hour and repeated weekly.
  • Received eight or fewer previous doses of docetaxel. Subjects that have received more than eight doses of docetaxel must receive permission from the GSK medical monitor in order to be eligible for the study.
  • ECOG performance status score of less than or equal to 2
  • NOTE: If the subject's performance status deteriorates between the screening Visit and the time of first dose of study drug to a score > 2, the subject will be excluded from the study
  • Adequate hematologic and other physiological organ function as evidenced by Absolute Neutrophil Count ≥1500/mm3. Platelets ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL Serum creatinine < 1.5 mg/dL Total Bilirubin ≤ upper limit of the reference range Aspartate Transaminase (AST) < 2 x upper limit of the reference range Alanine Transaminase (ALT) < 2 x upper limit of the reference range Alkaline Phosphatase < 2.5 x upper limit of the reference range. Calculated creatinine clearance > 50 mL/min (measured by Cockcroft Gault Formula;)
  • Written informed consent is obtained prior to any study-specific procedures or assessments.
  • Able to swallow and retain oral medications.

Who cannot join

  • Pregnant or lactating.
  • Received radiation therapy to the abdomen or the pelvis in the 28 days prior to receiving the first dose of study medication or that are scheduled to receive radiation therapy to the abdomen or the pelvis in the six days following the first dose of study medication.
  • Received a dose of docetaxel during the week prior to Day -1.
  • Known central nervous system primary or metastatic malignancy, unless successfully treated with excision or radiation and has been stable for at least 3 months prior to receiving the first dose of study medication.
  • Active systemic infection or any poorly controlled medical condition (other than malignancy) which, in the opinion of the investigator, may confound the results of the study or pose an unwarranted risk to the subject. Subjects with a previous, but not current, history of alcoholism may be permitted provided that, in the investigator's opinion, the subject's disease state will not confound the results of the study.
  • Receiving regular treatment with high dose systemic corticosteroid therapy or steroid dose within 72 hours prior to receiving the first dose of study medication. Topical steroids and inhaled corticosteroids with a steroid dose of less than or equal to 10 mg prednisone daily (or its equivalent) are permitted if the subject has been on this dose for at least 14 days prior to dosing.
Show all 23Show fewer
  • Hypersensitivity or contraindication to ondansetron or other 5-HT3 receptor antagonist, dexamethasone, docetaxel, casopitant, or any component of the above mentioned medications.
  • Received an investigational drug within the 28 days or five half-lives (whichever is longer) prior to receiving the first dose of study medication, or is scheduled to receive any investigational drug during the study.
  • Use of strong inhibitors of CYP3A4 or CYP3A5 prior to the first dose of study medication
  • Use of inducers of CYP3A4 or CYP3A5 (other than steroids described in Exclusion Criteria 5) within 14 days prior to the first dose of study medication
  • Use of drugs with a narrow therapeutic index that interact with the P-glycoprotein pathway within 14 days prior to the first dose of study medication until 14 days after the last dose of docetaxel including digoxin.
  • Use of drugs with a narrow therapeutic index that are metabolized by CYP2C8 within 14 days prior to the first dose of study medication including repaglinide and torsemide.
  • Disease that will significantly affect absorption of oral medications.
  • Inadequate venous access for pharmacokinetic sampling.
  • Unresolved Grade 2 or worse toxicity from prior therapy.
  • Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology. NOTE: Subject is eligible to enter and participate in this study if they have a history of PUD of known etiology with documentation from a gastroenterologist or other qualified physician of the etiology of the PUD and that effective treatment was provided with full eradication of ulcers and symptoms. Subjects who present with symptoms of gastroesophageal reflux disease (GERD) are eligible. However, if the investigator suspects PUD in such a subject, the subject must have a GI assessment to rule out PUD. If assessment is negative, subject may enter the study. For these subjects, appropriate steps must also have been taken to minimize the risk of reoccurrence. If PUD was non-steroidal anti-inflammatory drug (NSAID) induced, the subject should no longer be taking NSAID medication(s). If PUD was induced by H. pylori, the subject should have been appropriately treated.
  • Stool positive for occult blood. Test may be repeated once if subject did not abstain from red meat for the previous three days.
  • Pepsinogen level below the lower limit of laboratory reference range (LLRR).
  • Troponin level above 10% of the coefficient of variation of the assay as determined by the laboratory performing the test.
  • Calculated QT interval (QTc) > 480 msecs.
  • Clinically significant cardiac disease that would interfere with participation in the study as determined by the investigator.
  • Known or suspected iron deficiency.
  • Use of NSAIDS, including aspirin at any dose, and including COX2 inhibitors. These medications are prohibited 7 days prior to administration of study drug and for the duration of the study until 72 hours after the last dose of study drug.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Hot Springs, Arkansas, 71913

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Randomized, Two Period Crossover Study to Investigate the Effects of GW679769 on the Pharmacokinetics of Docetaxel in Subjects With Cancer

The purpose of the study is to evaluate the effect of the study drug (GW679769) on a commonly used chemotherapy drug (docetaxel) which will be given I.V. Blood samples will be taken to see if the GW679769 alters the blood levels of the chemotherapy. The study will last about 2 weeks with a final follow-up visit 6 weeks later.

Being tested
Docetaxel, Casopitant/Docetaxel
Keywords
Casopitant,, Neurokinin-1 Receptor Antagonist,, Drug-Interaction,, CYP3A, NK-1 Receptor Antagonist,, GW679769,, Docetaxel,
Medical subject headings
Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Docetaxel

  • Casopitant/DocetaxelDrug

    Also called Docetaxel, Casopitant

    Casopitant/Docetaxel

Study groups in NCT00440128
Study groupRoleWhat they receive
DocetaxelActive comparatorDocetaxel
Receives: Drug: Docetaxel
Docetaxel/CasopitantExperimentalDocetaxel/Casopitant
Receives: Drug: Casopitant/Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma levels of study drugs will be taken on Day 1 & 8.

    Plasma samples of study drugs

    Measured: taken on Day 1 & 8.

Secondary outcomes (7)

  1. Safety is evaluated by: -AEs monitored at each visit

    Measured: starting at Day 1.

  2. -Physical exam, vital signs, & ECOG performance status score

    Measured: at Screening, Day 1,8,&15.

  3. -ECG

    Measured: at Screening & Day 15.

  4. -Serum Pepsinogen levels monitored

    Measured: at Screening & Followup

  5. Terminal half-life (t1/2, as data permit), AUC(0-t), volume of distribution at steady state (Vdss), and clearance (Cl) of docetaxel

    Measured: on Day 1 and 8.

  6. Lowest measured absolute neutrophil count.

    Measured: on Day 1 and 8

  7. Physical exam findings, blood pressure, heart rate, clinical laboratory tests, clinical monitoring/observation, and adverse events reporting.

    Measured: on Day 1 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2007 (estimated)
  2. Study start4 May 2007
  3. Primary completion17 Jul 2008
  4. Study completion17 Jul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440128
Sponsor's protocol ID
NKV100781
Status last verified
Aug 2017
First submitted
22 Feb 2007
Last updated
4 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Dandamudi UB, Adams LM, Johnson B, Bauman J, Morris S, Murray S, Webb RT, Gartner E, Hohl R, Lewis LD. Lack of effect of casopitant on the pharmacokinetics of docetaxel in patients with cancer. Cancer Chemother Pharmacol. 2011 Apr;67(4):783-90. doi: 10.1007/s00280-010-1381-2. Epub 2010 Jun 17.

    PubMed 20556613

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Docetaxel and Casopitant/Docetaxel in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma levels of study drugs will be taken on Day 1 & 8. (time frame: taken on Day 1 & 8.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00440128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in