Advanced MalignanciesPhase 1NCT01930006
Safety Study of Two Oral Formulations of MGCD265 Administered in Healthy Subjects in the Fasting State
A Phase 1 study testing MGCD265 in people with Advanced Malignancies, run by Mirati Therapeutics Inc. at 1 site in United States.
Trial summary
In this study two MGCD265 oral formulations at dose level of 100 mg are administered to healthy male and female subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- MGCD265
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2013
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects ≥18 to ≤55 years of age who are willing and able to provide informed consent prior to performing any study related procedures
- Females of childbearing potential who are using a stable contraceptive method at least 30 days prior to screening and who are willing to use one of the following acceptable birth control methods until 30 days after the last dose of study drug:
- Abstinence
- Hormonal contraceptives (birth control pills, injectable/ implantable/ insertable hormonal birth control products, transdermal patch) for at least 3 months prior to the first dose of the study drug and male condom and intravaginal spermicide
- Intra-uterine contraceptive device (IUD) in place for at least 3 months prior to the first dose of study drug plus spermicide and male condom
- Male condom and diaphragm plus spermicide;
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- Male condom and cervical cap plus spermicide;
- Surgical sterilization of the partner(s) (vasectomy for 6 months minimum prior to the first dose of study drug)
- Female subjects will be considered of non childbearing potential and eligible if one of the following condition is met:
- Amenorrhea for at least 1 year, with confirmation by a follicle-stimulating hormone (FSH ≥ 40 mIU/mL)
- Hysterectomy
- Bilateral oophorectomy
- Bilateral tubal ligation
- Male subjects must agree to be abstinent or use the following acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 3 months after the last dose of study drug:
- Male condom and intravaginal spermicide plus hormonal contraceptives (birth control pills, injectable/ implantable/ insertable hormonal birth control products, transdermal patch) in use for at least 3 months
- Male condom and IUD in place for at least 3 months plus spermicide;
- Male condom and diaphragm plus spermicide
- Male condom and cervical cap plus spermicide
- Vasectomy for 6 months minimum prior to the first dose of study drug
- Male subjects also agree to not donate sperm from the time of taking the first dose of study drug until 3 months after the last dose of study drug
- Subject with a body mass index (BMI) of 18.0 to 32.0 kg/m2 at screening
- Subject is a current non-smoker and has not used any nicotine containing product within 3 months prior to screening
- Subjects who are considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results and screening ECG as judged by the investigator
- Subjects who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, pharmacokinetic sampling schedule and other study procedures
Who cannot join
- Females who are pregnant or are breast feeding
- History of significant hypersensitivity reaction to any substance or drug
- Clinically relevant history or evidence of significant gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, cardiovascular, hematologic, dermatologic, immunologic disease or any other condition known to interfere with the absorption, distribution, metabolism or distribution of drugs that in the opinion of the investigator would jeopardize the safety of the subject or impact validity of study results
- Clinically significant vital signs in the opinion of the investigator at screening or prior to study drug administration
- History of clinically significant cardiovascular illness including but not confined to: angina pectoris or myocardial infarction, coronary or peripheral artery bypass graft, congestive heart failure, or clinically significant cardiac arrhythmia in the opinion of the investigator
- History of clinically significant thrombotic or hemorrhagic events (including but not confined to stroke and transient ischemic attacks); history of bleeding diathesis or coagulopathy; history or presence of gastrointestinal or other conditions with risk of perforation; presence of a non-healing wound, ulcer or fracture in the opinion of the investigator
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- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTcF > 450 msec) at screening or the pre-dose ECG or other clinically significant ECG abnormalities in the opinion of the investigator
- History of regular alcohol consumption exceed 7 drinks for females and 14 drinks per week for males within 6 months of screening or a positive alcohol breath test at screening and prior to study drug administration
- History of significant drug abuse within one year prior to screening
- Any clinically significant illness or surgery in the previous 30 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 30 days before day 1 of this study
- Use of any drugs known to induce or inhibit hepatic metabolism (inducers such as rifampin, barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitors such as antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluroquinolones, antihistamines) in the previous 30 days before day 1 of the study
- Use of any other prescription medications in the previous 14 days before day 1 of this study
- Use of any over-the-counter (OTC) products including cold preparations, multivitamins and dietary supplements used for therapeutic benefits and antacid preparations in the previous 7 days before day 1 of this study
- Use of Acetylsalicylic Acid (ASA) or NSAIDs (or any product containing ASA or NSAIDs) in the previous 7 days before day 1 of this study
- Use of MAO inhibitors within 30 days of day 1 of the study
- Positive urine drug screen or urine cotinine test at screening and prior to study drug administration
- Positive results to HIV, HBsAg or anti-HCV tests at screening
- Subjects who took an Investigational Product (in another clinical trial) in the previous 30 days (90 days for biologics) before day 1 of this study
- Donation of plasma within 7 days prior to dosing. Any donation/loss of blood or blood products within 3 months of the screening visit
- Prior exposure to MGCD265
- No subjects will be allowed to enroll in this study more than once (i.e. if the study is conducted with more than 1 group).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
About this study
Official title: Phase 1 Single Dose 2-Way Crossover Comparative Bioavailability Study Of Two Oral Formulations Of MGCD265 In Healthy Male And Female Subjects - Fasting State
In this study two MGCD265 oral formulations at dose level of 100 mg are administered to healthy male and female subjects under fasting conditions.
Read the detailed description
The objective of this study is to compare the rate and extent of absorption of two MGCD265 oral formulations at a dose level of 100 mg administered to healthy male and female subjects under fasting conditions.
- Conditions
- Advanced Malignancies
- Being tested
- MGCD265
- Keywords
- c-Met, VEGFR, Ron, Cancer, Tumor, Safety, Phase 1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD265Drug
| Study group | Role | What they receive |
|---|---|---|
| MGCD265 | Experimental | Not described Receives: Drug: MGCD265 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the bioavailability of two MGCD265 formulations.
To compare the rate and extent of absorption of two MGCD265 oral formulations at dose level of 100 mg administered as 1 x 100 mg oral dose (Formulation A) and 2 x 50 mg oral dose (Formulation B) under fasting conditions.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930006
- Sponsor's protocol ID
- 265-106
- Status last verified
- Jan 2015
- First submitted
- 23 Aug 2013
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single Dose 2-Way Crossover Comparative Bioavailability Study Of Two Oral Formulations Of MGCD265 In Healthy Male And Female Subjects - Fasting State
- ClinicalTrials.gov ID
- NCT01930006
- Acronym / sponsor ID
- 265-106
- Conditions
- Advanced Malignancies
- Keywords
- c-Met, VEGFR, Ron, Cancer, Tumor, Safety, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study two MGCD265 oral formulations at dose level of 100 mg are administered to healthy male and female subjects under fasting conditions.
Detailed description
The objective of this study is to compare the rate and extent of absorption of two MGCD265 oral formulations at a dose level of 100 mg administered to healthy male and female subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGCD265 | Experimental | Drug: MGCD265 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Healthy male or female subjects ≥18 to ≤55 years of age who are willing and able to provide informed consent prior to performing any study related procedures
- Females of childbearing potential who are using a stable contraceptive method at least 30 days prior to screening and who are willing to use one of the following acceptable birth control methods until 30 days after the last dose of study drug:
- Female subjects will be considered of non childbearing potential and eligible if one of the following condition is met:
- Male subjects must agree to be abstinent or use the following acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 3 months after the last dose of study drug:
- Male subjects also agree to not donate sperm from the time of taking the first dose of study drug until 3 months after the last dose of study drug
Key exclusion criteria (22 listed)
- Females who are pregnant or are breast feeding
- History of significant hypersensitivity reaction to any substance or drug
- Clinically relevant history or evidence of significant gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, cardiovascular, hematologic, dermatologic, immunologic disease or any other condition known to interfere with the absorption, distribution, metabolism or distribution of drugs that in the opinion of the investigator would jeopardize the safety of the subject or impact validity of study results
- Clinically significant vital signs in the opinion of the investigator at screening or prior to study drug administration
- History of clinically significant cardiovascular illness including but not confined to: angina pectoris or myocardial infarction, coronary or peripheral artery bypass graft, congestive heart failure, or clinically significant cardiac arrhythmia in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGCD265 | Drug | MGCD265 |
Primary outcome
To assess the bioavailability of two MGCD265 formulations.
Time frame: Two months
To compare the rate and extent of absorption of two MGCD265 oral formulations at dose level of 100 mg administered as 1 x 100 mg oral dose (Formulation A) and 2 x 50 mg oral dose (Formulation B) under fasting conditions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGCD265 in people with Advanced Malignancies, run by Mirati Therapeutics Inc. at 1 site 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 24 inclusion and 22 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To assess the bioavailability of two MGCD265 formulations. (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2015.