NeoplasmsPhase 1NCT00730379
A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)
A Phase 1 study testing Comparator: ridaforolimus + dalotuzumab in people with Neoplasms, run by Merck Sharp & Dohme LLC.
Trial summary
This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Comparator: ridaforolimus + dalotuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Nov 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
- You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist
- In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens
- You must be over the age of 18 years old
- You must have a ECOG status performance of 0 or 1
- You must have good organ function
- You must be willing to have skin and/or tumor biopsies
Who cannot join
- You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies
- You have an active infection that requires treatment
- You are HIV positive or have a history of Hepatitis B or C
About this study
Official title: A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer
This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.
Read the detailed description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009
- Conditions
- Neoplasms
- Being tested
- Comparator: ridaforolimus + dalotuzumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: ridaforolimus + dalotuzumabDrug
Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ridaforolimus (MK8669) + dalotuzumab (MK0646) Receives: Drug: Comparator: ridaforolimus + dalotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
Measured: MTD from Day 1 to Day 28 in Cycle 1 for disease progression
Secondary outcomes (1)
To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab
Measured: At prescribed timepoints as defined in the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2010
- Study completionNov 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 NeoplasmsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730379
- Sponsor's protocol ID
- 8669-004
- Other IDs
- 2008_538
- Status last verified
- Feb 2015
- First submitted
- 6 Aug 2008
- Last updated
- 10 Feb 2015
- Results posted
- No
Publications
Di Cosimo S, Sathyanarayanan S, Bendell JC, Cervantes A, Stein MN, Brana I, Roda D, Haines BB, Zhang T, Winter CG, Jha S, Xu Y, Frazier J, Klinghoffer RA, Leighton-Swayze A, Song Y, Ebbinghaus S, Baselga J. Combination of the mTOR inhibitor ridaforolimus and the anti-IGF1R monoclonal antibody dalotuzumab: preclinical characterization and phase I clinical trial. Clin Cancer Res. 2015 Jan 1;21(1):49-59. doi: 10.1158/1078-0432.CCR-14-0940. Epub 2014 Oct 15.
PubMed 25320355
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00730379
- Acronym / sponsor ID
- 8669-004
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Study start
- Jul 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Aug 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.
This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.
Detailed description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Comparator: ridaforolimus + dalotuzumabridaforolimus (MK8669) + dalotuzumab (MK0646) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist
- In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens
- You must be over the age of 18 years old
- You must have a ECOG status performance of 0 or 1
- You must have good organ function
Key exclusion criteria (3 listed)
- You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies
- You have an active infection that requires treatment
- You are HIV positive or have a history of Hepatitis B or C
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 |
|---|---|---|
| Comparator: ridaforolimus + dalotuzumabStarting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s). | Drug | 1 |
Primary outcome
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
Time frame: MTD from Day 1 to Day 28 in Cycle 1 for disease progression
1 secondary outcome
To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab
Time frame: At prescribed timepoints as defined in the protocol
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 10 Feb 2015.
- Results publication: PubMed 25320355Di Cosimo S, Sathyanarayanan S, Bendell JC, Cervantes A, Stein MN, Brana I, Roda D, Haines BB, Zhang T, Winter CG, Jha S, Xu Y, Frazier J, Klinghoffer RA, Leighton-Swayze A, Song Y, Ebbinghaus S, Baselga J. Combination of the mTOR inhibitor ridaforolimus and the anti-IGF1R monoclonal antibody dalotuzumab: preclinical characterization and phase I clinical trial. Clin Cancer Res. 2015 Jan 1;21(1):49-59. doi: 10.1158/1078-0432.CCR-14-0940. Epub 2014 Oct 15.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator: ridaforolimus + dalotuzumab in people with Neoplasms, 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 6 inclusion and 3 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 10 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?
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. (time frame: MTD from Day 1 to Day 28 in Cycle 1 for disease progression). 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 NCT00730379, 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 10 Feb 2015.