Advanced CancerPhase 1NCT01295632

Safety and Tolerability of Different Dose Combinations of Ridaforolimus With MK-2206 or MK-0752 for Participants With Advanced Cancer (MK-8669-049)

A Phase 1 study testing ridaforolimus, MK-0752 and MK-2206 in people with Advanced Cancer, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer
What is being tested?: ridaforolimus, MK-0752 and MK-2206
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: No sites listed yet
Study dates: Feb 2011to Aug 2015
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

Part A of the Study:
Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Non Hodgkin Lymphoma (NHL) participants (in Part A only), must have histologically confirmed relapsed/refractory NHL. There is no limit on the number of prior treatment regimens.
Part B of the Study:
Participant must have performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Participant must have adequate organ function.
Participants must be willing to use effective methods of contraception.

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Participant is able to swallow capsules and has no surgical or anatomical condition that will preclude the participant from swallowing and absorbing oral medications on an ongoing basis.
Participant has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with Prostate-Specific Antigen (PSA) <1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician.
Participant has at least one measurable recurrent or metastatic lesion (if a solitary lesion, histological/cytological confirmation of its neoplastic nature is required) with the exception of prostate cancer participants which do not require measurable disease if participant has PSA level of >10 ng/mL.
Participant must agree to provide archival or newly-obtained tumor tissue sample.
Ridaforolimus + MK-2206 Treatment Arm:
Participant must have a histologically-confirmed prostate cancer that is refractory to hormone therapy and for which the participant received any number of prior treatment regimens (no longer recruiting as of 30 November 2012), OR
Participant must have a histologically-confirmed breast cancer for which the participant received any number of prior treatment regimens. Archival or fresh tissue must demonstrate a low RAS-gene signature and a high Ki67 index label if estrogen receptor (ER)+
Ridaforolimus + MK-0752 Treatment Arm:
Participant must have a histologically-confirmed recurrent (either primary or secondary) glioblastoma multiforme with radiographic evidence of progression/recurrence of disease, and up to 2 prior treatment regimens for their recurrent disease, and no prior treatment with bevacizumab, OR
Participants must have a histologically-confirmed relapsed or refractory ovarian cancer for which the participant received no more than 2 prior treatment regiments which was either relapsed or refractory to the first line treatment.

Who cannot join

Participant has had chemotherapy or radiotherapy within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas, mitomycin C), biological therapy (excluding antibodies) within 2 weeks prior to study Day 1, or who has not recovered (≤Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier. Luteinizing-hormone releasing hormone (LHRH) use by prostate cancer patients is permitted; participants with prostate cancer previously treated with flutamide or nilutamide require 4 week washout period and participants previously treated with bicalutamide require 6 week washout period before study drug administration.
Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (not including monoclonal antibodies), whichever is longer, of Day 1 of this study.
Participants with known symptomatic or progressing Central Nervous System (CNS) metastases and/or carcinomatous meningitis are excluded. However, participants with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids.
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has prior exposure to agents that have the same target as to the study drug.
Participant has significant or uncontrolled cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a myocardial infarction within the last 6 months.

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Participant is a known diabetic participant who is poorly controlled at screening.
Participant has known psychiatric or substance abuse disorders that would interfere with compliance with study requirements.
Participant is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Participant is known to be Human Immunodeficiency Virus (HIV)-positive.
Participant has active Hepatitis B or C.
Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions is eligible.
Participant has a requirement for concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study drug.
Participant has a requirement for concurrent treatment with medication(s) that strongly or moderate induce or inhibit cytochrome P450 (CYP3A). Participants should be off these medications ≥ 2 weeks prior to the first dose of study medication.
For participants with glioblastoma, dexamethasone should be discontinued at least 1 week prior to the first dose of study drugs.
For participants on the Ridaforolimus + MK-0752 treatment arm:
Participant requires or anticipated to require concomitant therapy with enzyme-inducing antiepileptic therapy.

About this study

Official title: Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MK-MK) in Patients With Advanced Cancer

This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752. In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug combinations will be found by giving sequentially higher doses of the study drugs. An expansion cohort of participants may be enrolled to confirm the MTD. New cohorts at other dose levels may be enrolled, depending on the rate of dose limiting toxicities (DLTs) in the planned cohorts. In Part B, an assessment of the efficacy of the drug combinations against selected advanced cancers will be made so that a recommended dose to be used in Phase 2 studies (RPTD) can be found. As of 19 July 2012 the MK-0752 arms of the study were fully enrolled and closed to further recruitment. As of 30 November 2012, no additional participants with prostate cancer will be enrolled.

Conditions: Advanced Cancer
Being tested: ridaforolimus, MK-0752, MK-2206
Keywords: Recurrent glioblastoma multiforme, Hormone resistant prostate cancer, Relapsed ovarian carcinoma, Refractory ovarian carcinoma, Refractory breast cancer, Relapsed breast cancer
Medical subject headings: Glioblastoma, Ovarian Neoplasms, Breast Neoplasms

What participants receive

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

ridaforolimusDrug
Also called MK-8669
10 mg enteric-coated tablets, orally, starting dose 2 tablets and escalating to 4 tablets each day for 5 days per week.
MK-0752Drug
300 mg capsule, orally, 6 capsules per dose, once each week.
MK-2206Drug
Tablets (5 mg, 25 mg, and 200 mg) to equal starting dose of 90 mg and escalating to 200 mg per dose, orally, once each week.

Study groups in NCT01295632
Study group	Role	What they receive
Ridaforolimus 20 mg + MK-2206 90 mg	Experimental	Not described Receives: Drug: ridaforolimus; Drug: MK-2206
Ridaforolimus 20 mg + MK-2206 135 mg	Experimental	Not described Receives: Drug: ridaforolimus; Drug: MK-2206
Ridaforolimus 30 mg + MK-2206 90 mg	Experimental	Not described Receives: Drug: ridaforolimus; Drug: MK-2206
Ridaforolimus 30 mg + MK-2206 135 mg	Experimental	Not described Receives: Drug: ridaforolimus; Drug: MK-2206
Ridaforolimus 30 mg + MK-2206 200 mg	Experimental	Not described Receives: Drug: ridaforolimus; Drug: MK-2206
Ridaforolimus 40 mg + MK-2206 135 mg	Experimental	Not described Receives: Drug: ridaforolimus; Drug: MK-2206
Ridaforolimus 40 mg + MK-2206 200 mg	Experimental	Not described Receives: Drug: ridaforolimus; Drug: MK-2206
Ridaforolimus 20 mg + MK-0752 1800 mg	Experimental	No longer recruiting as of 19 July 2012 Receives: Drug: ridaforolimus; Drug: MK-0752
Ridaforolimus 30 mg + MK-0752 1800 mg	Experimental	No longer recruiting as of 19 July 2012 Receives: Drug: ridaforolimus; Drug: MK-0752
Ridaforolimus 40 mg + MK-0752 1800 mg	Experimental	No longer recruiting as of 19 July 2012 Receives: Drug: ridaforolimus; Drug: MK-0752

What is being measured

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

Number of participants receiving ridaforolimus + MK-2206 who experience dose-limiting toxicities (DLTs).
Measured: Cycle 1 (28 days)
Number of participants receiving ridaforolimus + MK-0752 who experience DLTs.
Measured: Cycle 1 (28 days)
Number of participants whose best response is partial response (PR) or complete response (CR).
Measured: Day 22-29, every other month.

Secondary outcomes (4)

Area under the plasma concentration curve (AUC) for ridaforolimus.
Measured: Part A, Cycle 0, Day 1 (pre-dose)
Area under the plasma concentration curve (AUC) for ridaforolimus.
Measured: Part A, Cycle 0, Day 5 (pre- and post-dose)
AUC for the ridaforolimus + MK-0752 doublet
Measured: Part A, Cycle 1, Day 1 (pre-dose)
AUC for the ridaforolimus + MK-0752 doublet
Measured: Part A, Cycle 1, Day 12 (pre- and post-dose)

Timeline

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

Feb 2011Aug 2015

First posted14 Feb 2011 (estimated)
Study startFeb 2011
Primary completionDec 2013
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Advanced CancerStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Parallel groups
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01295632
Sponsor's protocol ID: 8669-049
Status last verified: Aug 2015
First submitted: 9 Feb 2011
Last updated: 27 Aug 2015
Results posted: No
Data monitoring committee: No

Publications

Piha-Paul SA, Munster PN, Hollebecque A, Argiles G, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Gupta S. Results of a phase 1 trial combining ridaforolimus and MK-0752 in patients with advanced solid tumours. Eur J Cancer. 2015 Sep;51(14):1865-73. doi: 10.1016/j.ejca.2015.06.115. Epub 2015 Jul 18.
PubMed 26199039
Gupta S, Argiles G, Munster PN, Hollebecque A, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Piha-Paul SA. A Phase I Trial of Combined Ridaforolimus and MK-2206 in Patients with Advanced Malignancies. Clin Cancer Res. 2015 Dec 1;21(23):5235-44. doi: 10.1158/1078-0432.CCR-15-0180. Epub 2015 Jul 17.
PubMed 26187616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MK-MK) in Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT01295632
Acronym / sponsor ID: 8669-049
Conditions: Advanced Cancer
Keywords: Recurrent glioblastoma multiforme, Hormone resistant prostate cancer, Relapsed ovarian carcinoma, Refractory ovarian carcinoma, Refractory breast cancer, Relapsed breast cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Dec 2013 (actual)
Study completion: Aug 2015 (actual)
First posted: 14 Feb 2011 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Ridaforolimus 20 mg + MK-2206 90 mg	Experimental	Drug: ridaforolimus, Drug: MK-2206
Ridaforolimus 20 mg + MK-2206 135 mg	Experimental	Drug: ridaforolimus, Drug: MK-2206
Ridaforolimus 30 mg + MK-2206 90 mg	Experimental	Drug: ridaforolimus, Drug: MK-2206
Ridaforolimus 30 mg + MK-2206 135 mg	Experimental	Drug: ridaforolimus, Drug: MK-2206
Ridaforolimus 30 mg + MK-2206 200 mg	Experimental	Drug: ridaforolimus, Drug: MK-2206
Ridaforolimus 40 mg + MK-2206 135 mg	Experimental	Drug: ridaforolimus, Drug: MK-2206
Ridaforolimus 40 mg + MK-2206 200 mg	Experimental	Drug: ridaforolimus, Drug: MK-2206
Ridaforolimus 20 mg + MK-0752 1800 mg	Experimental	Drug: ridaforolimus, Drug: MK-0752No longer recruiting as of 19 July 2012
Ridaforolimus 30 mg + MK-0752 1800 mg	Experimental	Drug: ridaforolimus, Drug: MK-0752No longer recruiting as of 19 July 2012
Ridaforolimus 40 mg + MK-0752 1800 mg	Experimental	Drug: ridaforolimus, Drug: MK-0752No longer recruiting as of 19 July 2012

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Non Hodgkin Lymphoma (NHL) participants (in Part A only), must have histologically confirmed relapsed/refractory NHL. There is no limit on the number of prior treatment regimens.
Participant must have performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Participant must have adequate organ function.
Participants must be willing to use effective methods of contraception.
Participant is able to swallow capsules and has no surgical or anatomical condition that will preclude the participant from swallowing and absorbing oral medications on an ongoing basis.

Key exclusion criteria (18 listed)

Participant has had chemotherapy or radiotherapy within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas, mitomycin C), biological therapy (excluding antibodies) within 2 weeks prior to study Day 1, or who has not recovered (≤Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier. Luteinizing-hormone releasing hormone (LHRH) use by prostate cancer patients is permitted; participants with prostate cancer previously treated with flutamide or nilutamide require 4 week washout period and participants previously treated with bicalutamide require 6 week washout period before study drug administration.
Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (not including monoclonal antibodies), whichever is longer, of Day 1 of this study.
Participants with known symptomatic or progressing Central Nervous System (CNS) metastases and/or carcinomatous meningitis are excluded. However, participants with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids.
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has prior exposure to agents that have the same target as to the study drug.

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
ridaforolimusAlso: MK-866910 mg enteric-coated tablets, orally, starting dose 2 tablets and escalating to 4 tablets each day for 5 days per week.	Drug	Ridaforolimus 20 mg + MK-0752 1800 mg, Ridaforolimus 20 mg + MK-2206 135 mg, Ridaforolimus 20 mg + MK-2206 90 mg, Ridaforolimus 30 mg + MK-0752 1800 mg, Ridaforolimus 30 mg + MK-2206 135 mg, Ridaforolimus 30 mg + MK-2206 200 mg, Ridaforolimus 30 mg + MK-2206 90 mg, Ridaforolimus 40 mg + MK-0752 1800 mg, Ridaforolimus 40 mg + MK-2206 135 mg, Ridaforolimus 40 mg + MK-2206 200 mg
MK-0752300 mg capsule, orally, 6 capsules per dose, once each week.	Drug	Ridaforolimus 20 mg + MK-0752 1800 mg, Ridaforolimus 30 mg + MK-0752 1800 mg, Ridaforolimus 40 mg + MK-0752 1800 mg
MK-2206Tablets (5 mg, 25 mg, and 200 mg) to equal starting dose of 90 mg and escalating to 200 mg per dose, orally, once each week.	Drug	Ridaforolimus 20 mg + MK-2206 135 mg, Ridaforolimus 20 mg + MK-2206 90 mg, Ridaforolimus 30 mg + MK-2206 135 mg, Ridaforolimus 30 mg + MK-2206 200 mg, Ridaforolimus 30 mg + MK-2206 90 mg, Ridaforolimus 40 mg + MK-2206 135 mg, Ridaforolimus 40 mg + MK-2206 200 mg

Primary outcome

Number of participants receiving ridaforolimus + MK-2206 who experience dose-limiting toxicities (DLTs).
Time frame: Cycle 1 (28 days)
Number of participants receiving ridaforolimus + MK-0752 who experience DLTs.
Time frame: Cycle 1 (28 days)
Number of participants whose best response is partial response (PR) or complete response (CR).
Time frame: Day 22-29, every other month.

4 secondary outcomes

Area under the plasma concentration curve (AUC) for ridaforolimus.
Time frame: Part A, Cycle 0, Day 1 (pre-dose)
Area under the plasma concentration curve (AUC) for ridaforolimus.
Time frame: Part A, Cycle 0, Day 5 (pre- and post-dose)
AUC for the ridaforolimus + MK-0752 doublet
Time frame: Part A, Cycle 1, Day 1 (pre-dose)
AUC for the ridaforolimus + MK-0752 doublet
Time frame: Part A, Cycle 1, Day 12 (pre- and post-dose)

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 27 Aug 2015.
Background: PubMed 26199039Piha-Paul SA, Munster PN, Hollebecque A, Argiles G, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Gupta S. Results of a phase 1 trial combining ridaforolimus and MK-0752 in patients with advanced solid tumours. Eur J Cancer. 2015 Sep;51(14):1865-73. doi: 10.1016/j.ejca.2015.06.115. Epub 2015 Jul 18.
Background: PubMed 26187616Gupta S, Argiles G, Munster PN, Hollebecque A, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Piha-Paul SA. A Phase I Trial of Combined Ridaforolimus and MK-2206 in Patients with Advanced Malignancies. Clin Cancer Res. 2015 Dec 1;21(23):5235-44. doi: 10.1158/1078-0432.CCR-15-0180. Epub 2015 Jul 17.

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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 ridaforolimus, MK-0752 and MK-2206 in people with Advanced Cancer, run by Merck Sharp & Dohme LLC.

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 16 inclusion and 18 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 27 Aug 2015. 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 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?

Number of participants receiving ridaforolimus + MK-2206 who experience dose-limiting toxicities (DLTs). (time frame: Cycle 1 (28 days)). The study lists 3 primary outcomes in all. 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 NCT01295632, which also lists 2 linked publications.

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 27 Aug 2015.