Solid TumorsPhase 1NCT00871663
Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)
A Phase 1 study testing SCH 727965 in people with Solid Tumors and Lymphoma, Non-Hodgkin, run by Merck Sharp & Dohme LLC.
Trial summary
The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma
- What is being tested?
- SCH 727965
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Oct 2012
- 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
- Age >=18 years, either sex, any race.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- There must be no known standard therapy, or disease must be refractory to standard therapy
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters
- For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:
- Participants must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
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- Evaluable malignancy must be present by computed tomography or magnetic resonance imaging, obtained within 4 weeks prior to the start of treatment with SCH 727965.
- Subjects with multiple myeloma must have measurable disease defined as:
- Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
- Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:
- serum free light chain ratio greater than 5 times the normal ratio limit; and/or
- measurable soft tissue plasmacytoma greater than 2 cm, by either physical examination and/or applicable radiographs; and/or
- bone marrow involvement greater than 30%.
- For B-cell chronic lymphocytic leukemia (B-CLL):
- Diagnosis of B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria or a histological diagnosis of small lymphocytic lymphoma.
- Disease must be evaluable according to NCI-WG response criteria.
Who cannot join
- Symptomatic brain metastases or primary central nervous system malignancy.
- Previous radiation therapy to >25% of the total bone marrow.
- Previous treatment with SCH 727965.
- Known HIV infection.
About this study
Official title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies
The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
- Conditions
- Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphocytic, Chronic. B-Cell
- Being tested
- SCH 727965
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 727965Drug
Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Advanced solid tumors | Experimental | Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts Receives: Drug: SCH 727965 |
| Non-Hodgkin's lymphoma and multiple myeloma | Experimental | Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965 Receives: Drug: SCH 727965 |
| B cell chronic lymphocytic leukemia | Experimental | Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts Receives: Drug: SCH 727965 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity.
Measured: End of trial
In participants with advanced solid tumors, non Hodgkin's lymphoma or multiple myeloma, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
Measured: End of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startAug 2006
- Primary completionOct 2012
- Study completionOct 2012
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 Solid TumorsStudies 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871663
- Sponsor's protocol ID
- P04629
- Status last verified
- Apr 2015
- First submitted
- 26 Mar 2009
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Flynn J, Jones J, Johnson AJ, Andritsos L, Maddocks K, Jaglowski S, Hessler J, Grever MR, Im E, Zhou H, Zhu Y, Zhang D, Small K, Bannerji R, Byrd JC. Dinaciclib is a novel cyclin-dependent kinase inhibitor with significant clinical activity in relapsed and refractory chronic lymphocytic leukemia. Leukemia. 2015 Jul;29(7):1524-9. doi: 10.1038/leu.2015.31. Epub 2015 Feb 24.
PubMed 25708835Nemunaitis JJ, Small KA, Kirschmeier P, Zhang D, Zhu Y, Jou YM, Statkevich P, Yao SL, Bannerji R. A first-in-human, phase 1, dose-escalation study of dinaciclib, a novel cyclin-dependent kinase inhibitor, administered weekly in subjects with advanced malignancies. J Transl Med. 2013 Oct 16;11:259. doi: 10.1186/1479-5876-11-259.
PubMed 24131779
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00871663
- Acronym / sponsor ID
- P04629
- Conditions
- Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphocytic, Chronic. B-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Mar 2009 (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 study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advanced solid tumors | Experimental | Drug: SCH 727965Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts |
| Non-Hodgkin's lymphoma and multiple myeloma | Experimental | Drug: SCH 727965Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965 |
| B cell chronic lymphocytic leukemia | Experimental | Drug: SCH 727965Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age >=18 years, either sex, any race.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- There must be no known standard therapy, or disease must be refractory to standard therapy
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters
- For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:
Key exclusion criteria (4 listed)
- Symptomatic brain metastases or primary central nervous system malignancy.
- Previous radiation therapy to >25% of the total bone marrow.
- Previous treatment with SCH 727965.
- Known HIV infection.
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 |
|---|---|---|
| SCH 727965Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle. | Drug | Advanced solid tumors, B cell chronic lymphocytic leukemia, Non-Hodgkin's lymphoma and multiple myeloma |
Primary outcome
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity.
Time frame: End of trial
In participants with advanced solid tumors, non Hodgkin's lymphoma or multiple myeloma, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
Time frame: End of trial
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 20 Apr 2015.
- Background: PubMed 25708835Flynn J, Jones J, Johnson AJ, Andritsos L, Maddocks K, Jaglowski S, Hessler J, Grever MR, Im E, Zhou H, Zhu Y, Zhang D, Small K, Bannerji R, Byrd JC. Dinaciclib is a novel cyclin-dependent kinase inhibitor with significant clinical activity in relapsed and refractory chronic lymphocytic leukemia. Leukemia. 2015 Jul;29(7):1524-9. doi: 10.1038/leu.2015.31. Epub 2015 Feb 24.
- Results publication: PubMed 24131779Nemunaitis JJ, Small KA, Kirschmeier P, Zhang D, Zhu Y, Jou YM, Statkevich P, Yao SL, Bannerji R. A first-in-human, phase 1, dose-escalation study of dinaciclib, a novel cyclin-dependent kinase inhibitor, administered weekly in subjects with advanced malignancies. J Transl Med. 2013 Oct 16;11:259. doi: 10.1186/1479-5876-11-259.
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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 SCH 727965 in people with Solid Tumors and Lymphoma, Non-Hodgkin, 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 4 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 20 Apr 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?
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity. (time frame: End of trial). The study lists 2 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 NCT00871663, 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 20 Apr 2015.