Solid TumorPhase 1NCT00781846
Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers (8669-010)(COMPLETED)
A Phase 1 study testing ridaforolimus and bevacizumab in people with Solid Tumor, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral ridaforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ridaforolimus and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Feb 2010
- 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
- 18 years of age or older
- Advanced or metastatic solid tumor malignancy
- ECOG performance status of less than or equal to 1
- Life expectancy of greater than 3 months
- At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy, or radiotherapy, and the first dose of deforolimus
- Adequate hematological, hepatic and renal function
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- Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
- Signed informed consent
- Women of childbearing potential must have a negative serum pregnancy test within 7 days of starting therapy and must use an approved contraceptive method from time of screening until 30 days after the last dose of study drug
Who cannot join
- Tumor location in close proximity to a major blood vessel
- History of brain metastases, spinal cord compression, or carcinomatous meningitis. Primary brain tumors (for example, glioblastoma) are allowed.
- New brain metastases, spinal cord compression, or leptomeningeal metastases on screening CT scan or MRI
- Hemoptysis or hematemesis within 28 days prior to entering the trial
- Clinical significant unexplained bleeding within 28 days prior to entering the trial
- Uncontrolled hypertension
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- Proteinuria at screening
- Clinically significant cardiovascular disease
- Newly diagnosed or poorly controlled type 1 or 2 diabetes
- Active infection requiring prescribed intervention
- Other concurrent illness that, in the Investigator's judgement, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
- Major surgery within 28 days before trial entry, or any incompletely healed surgical incision; minor surgery or procedures within 7 days
- Pregnant or breastfeeding
- Known allergy to macrolide antibiotics
- Known hypersensitivity to any component of bevacizumab
- Concurrent treatment with medications that strongly induce or inhibit cytochrome P450 (CYP3A)
- Known history of HIV sero-positivity
- Any condition in the Investigator's judgement that renders the patient unable to fully understand and provide informed consent and/or comply with the protocol
About this study
Official title: A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers
The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral ridaforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers.
- Conditions
- Solid Tumor
- Being tested
- ridaforolimus, bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridaforolimusDrug
Also called deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
oral tablets, daily for 5 days/week
bevacizumabDrug
Also called avastin
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks Receives: Drug: ridaforolimus; Drug: bevacizumab |
| 2 | Experimental | 40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks Receives: Drug: ridaforolimus; Drug: bevacizumab |
| 3 | Experimental | 40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks Receives: Drug: ridaforolimus; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab
Measured: Duration of the trial
Secondary outcomes (2)
Characterize the overall safety and tolerability of ridaforolimus in combination with bevacizumab
Measured: Duration of the study
Description of the anti-tumor activity of ridaforolimus in combination with bevacizumab
Measured: Duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Frank Haluska, MD, PhD, Study director, Ariad Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781846
- Sponsor's protocol ID
- 8669-010
- Other IDs
- AP23573-08-111
- Status last verified
- Feb 2015
- First submitted
- 28 Oct 2008
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nemunaitis J, Hochster HS, Lustgarten S, Rhodes R, Ebbinghaus S, Turner CD, Dodion PF, Mita MM. A phase I trial of oral ridaforolimus (AP23573; MK-8669) in combination with bevacizumab for patients with advanced cancers. Clin Oncol (R Coll Radiol). 2013 Jun;25(6):336-42. doi: 10.1016/j.clon.2013.02.005. Epub 2013 Apr 21.
PubMed 23615181
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT00781846
- Acronym / sponsor ID
- 8669-010
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Oct 2008 (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.
The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral ridaforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ridaforolimus, Drug: bevacizumab30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks |
| 2 | Experimental | Drug: ridaforolimus, Drug: bevacizumab40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks |
| 3 | Experimental | Drug: ridaforolimus, Drug: bevacizumab40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Advanced or metastatic solid tumor malignancy
- ECOG performance status of less than or equal to 1
- Life expectancy of greater than 3 months
- At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy, or radiotherapy, and the first dose of deforolimus
Key exclusion criteria (18 listed)
- Tumor location in close proximity to a major blood vessel
- History of brain metastases, spinal cord compression, or carcinomatous meningitis. Primary brain tumors (for example, glioblastoma) are allowed.
- New brain metastases, spinal cord compression, or leptomeningeal metastases on screening CT scan or MRI
- Hemoptysis or hematemesis within 28 days prior to entering the trial
- Clinical significant unexplained bleeding within 28 days prior to entering the trial
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: deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009oral tablets, daily for 5 days/week | Drug | 1, 2, 3 |
| bevacizumabAlso: avastinIV infusion | Drug | 1, 2, 3 |
Primary outcome
Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab
Time frame: Duration of the trial
2 secondary outcomes
Characterize the overall safety and tolerability of ridaforolimus in combination with bevacizumab
Time frame: Duration of the study
Description of the anti-tumor activity of ridaforolimus in combination with bevacizumab
Time frame: Duration of the study
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 13 Feb 2015.
- Results publication: PubMed 23615181Nemunaitis J, Hochster HS, Lustgarten S, Rhodes R, Ebbinghaus S, Turner CD, Dodion PF, Mita MM. A phase I trial of oral ridaforolimus (AP23573; MK-8669) in combination with bevacizumab for patients with advanced cancers. Clin Oncol (R Coll Radiol). 2013 Jun;25(6):336-42. doi: 10.1016/j.clon.2013.02.005. Epub 2013 Apr 21.
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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.
Frank Haluska, MD, PhD study director
Ariad Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ridaforolimus and bevacizumab in people with Solid Tumor, 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 9 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 13 Feb 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?
Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab (time frame: Duration of the trial). 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 NCT00781846, 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 13 Feb 2015.