Cancer: Solid TumorsPhase 1NCT01110603
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
A Phase 1 study testing MK-4827, carboplatin and paclitaxel in people with Cancer: Solid Tumors, run by Tesaro, Inc..
Trial summary
This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer: Solid Tumors
- What is being tested?
- MK-4827, carboplatin and paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2011
- 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
- Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
- Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Who cannot join
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
- Participant has had more than two prior lines of chemotherapy.
- Participant has known central nervous system metastases or a primary central nervous system tumor.
- Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
- Participant is known to be human immunodeficiency virus (HIV) positive.
- Participant has a history of Hepatitis B or C.
- Participant has a symptomatic pleural effusion.
- Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.
About this study
Official title: A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors
This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.
Read the detailed description
The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.
- Conditions
- Cancer: Solid Tumors
- Being tested
- MK-4827, carboplatin, paclitaxel, liposomal doxorubicin
- Keywords
- Cancer, Advanced Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4827Drug
Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.
carboplatinDrug
Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
paclitaxelDrug
Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle
liposomal doxorubicinDrug
Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| MK-4827 + carboplatin | Experimental | Not described Receives: Drug: MK-4827; Drug: carboplatin |
| MK-4827 + carboplatin/paclitaxel | Experimental | Not described Receives: Drug: MK-4827; Drug: carboplatin; Drug: paclitaxel |
| MK-4827 + carboplatin/liposomal doxorubicin | Experimental | Not described Receives: Drug: MK-4827; Drug: carboplatin; Drug: liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs)
Measured: Each cycle (21 or 28 Days)
Secondary outcomes (1)
Number of participants with clinical and laboratory adverse events (AEs)
Measured: Baseline to 30 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer: Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tesaro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110603
- Sponsor's protocol ID
- 2010_528
- Other IDs
- MK-4827-008
- Status last verified
- Mar 2012
- First submitted
- 22 Apr 2010
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01110603
- Acronym / sponsor ID
- 2010_528
- Conditions
- Cancer: Solid Tumors
- Keywords
- Cancer, Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Apr 2010 (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.
This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.
Detailed description
The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MK-4827 + carboplatin | Experimental | Drug: MK-4827, Drug: carboplatin |
| MK-4827 + carboplatin/paclitaxel | Experimental | Drug: MK-4827, Drug: carboplatin, Drug: paclitaxel |
| MK-4827 + carboplatin/liposomal doxorubicin | Experimental | Drug: MK-4827, Drug: carboplatin, Drug: liposomal doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
- Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Key exclusion criteria (8 listed)
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
- Participant has had more than two prior lines of chemotherapy.
- Participant has known central nervous system metastases or a primary central nervous system tumor.
- Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
- Participant is known to be human immunodeficiency virus (HIV) positive.
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 |
|---|---|---|
| MK-4827Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose. | Drug | MK-4827 + carboplatin, MK-4827 + carboplatin/liposomal doxorubicin, MK-4827 + carboplatin/paclitaxel |
| carboplatinIntravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle | Drug | MK-4827 + carboplatin, MK-4827 + carboplatin/liposomal doxorubicin, MK-4827 + carboplatin/paclitaxel |
| paclitaxelIntravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle | Drug | MK-4827 + carboplatin/paclitaxel |
| liposomal doxorubicinIntravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle | Drug | MK-4827 + carboplatin/liposomal doxorubicin |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: Each cycle (21 or 28 Days)
1 secondary outcome
Number of participants with clinical and laboratory adverse events (AEs)
Time frame: Baseline to 30 days post last dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-4827, carboplatin and paclitaxel in people with Cancer: Solid Tumors, run by Tesaro, Inc..
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Number of participants with dose limiting toxicities (DLTs) (time frame: Each cycle (21 or 28 Days)). 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 5 May 2016.