Solid TumorsPhase 1NCT00871910
Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)
A Phase 1 study testing SCH 727965, Aprepitant and Ondansetron in people with Solid Tumors and Lymphoma, Non-Hodgkin, run by Merck Sharp & Dohme LLC.
Trial summary
Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. 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, Aprepitant and Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2006to 22 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
- Age >=18 years, either sex, any race.
- Subjects must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
- There must be no known standard therapy, or disease must be refractory to standard therapy.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
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 Every 3 Weeks in Subjects With Advanced Malignancies
Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH 727965 administered as a 2 hour IV infusion once every 3 weeks.
- Conditions
- Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma
- Being tested
- SCH 727965, Aprepitant, Ondansetron, Dexamethasone
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 727965Drug
SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)
SCH 727965Drug
SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts
SCH 727965Drug
SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts
SCH 727965Drug
SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle
AprepitantDrug
Also called Emend
Oral aprepitant in Cycle 1 or Cycle 2, depending on the study arm: 125 mg 1 hour prior to the SCH 727965 infusion on Day 1, and 80 mg on Days 2 and 3.
OndansetronDrug
Also called Zofran
Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
DexamethasoneDrug
Also called Decadron
Oral dexamethasone in Cycles 1 and 2: 12 mg 30 minutes prior to the SCH 727965 infusion on Day 1, and 8 mg in the morning on Days 2, 3, and 4.
| Study group | Role | What they receive |
|---|---|---|
| 2 Hour SCH 727965 infusion | Experimental | Participants treated with 2 hour SCH 727965 IV infusion Receives: Drug: SCH 727965 |
| 8 Hour SCH 727965 infusion | Experimental | Participants treated with 8 hour SCH 727965 IV infusion. Receives: Drug: SCH 727965 |
| 24 Hour SCH 727965 infusion | Experimental | Participants treated with 24 hour SCH 727965 IV infusion. Receives: Drug: SCH 727965 |
| 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1 | Experimental | Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only. Receives: Drug: SCH 727965; Drug: Aprepitant; Drug: Ondansetron; Drug: Dexamethasone |
| 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2 | Experimental | Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only. Receives: Drug: SCH 727965; Drug: Aprepitant; Drug: Ondansetron; Drug: Dexamethasone |
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 Part 1 and Part 2, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
Measured: Cycle 1
Secondary outcomes (1)
In Part 3, area under the plasma concentration versus time curve and maximum concentration of SCH 727965 administered as a 2 hour intravenous infusion with or without aprepitant in participants with advanced malignancies.
Measured: Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2
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 start11 Oct 2006
- Primary completion22 Feb 2010
- Study completion22 Feb 2010
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
- 81 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
- NCT00871910
- Sponsor's protocol ID
- P04630
- Status last verified
- Oct 2017
- First submitted
- 26 Mar 2009
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang D, Mita M, Shapiro GI, Poon J, Small K, Tzontcheva A, Kantesaria B, Zhu Y, Bannerji R, Statkevich P. Effect of aprepitant on the pharmacokinetics of the cyclin-dependent kinase inhibitor dinaciclib in patients with advanced malignancies. Cancer Chemother Pharmacol. 2012 Dec;70(6):891-8. doi: 10.1007/s00280-012-1967-y. Epub 2012 Oct 9.
PubMed 23053255Mita MM, Mita AC, Moseley JL, Poon J, Small KA, Jou YM, Kirschmeier P, Zhang D, Zhu Y, Statkevich P, Sankhala KK, Sarantopoulos J, Cleary JM, Chirieac LR, Rodig SJ, Bannerji R, Shapiro GI. Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies. Br J Cancer. 2017 Oct 24;117(9):1258-1268. doi: 10.1038/bjc.2017.288. Epub 2017 Aug 31.
PubMed 28859059
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. 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 Every 3 Weeks in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00871910
- Acronym / sponsor ID
- P04630
- Conditions
- Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2006 (actual)
- Primary completion
- 22 Feb 2010 (actual)
- Study completion
- 22 Feb 2010 (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.
Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH 727965 administered as a 2 hour IV infusion once every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 Hour SCH 727965 infusion | Experimental | Drug: SCH 727965Participants treated with 2 hour SCH 727965 IV infusion |
| 8 Hour SCH 727965 infusion | Experimental | Drug: SCH 727965Participants treated with 8 hour SCH 727965 IV infusion. |
| 24 Hour SCH 727965 infusion | Experimental | Drug: SCH 727965Participants treated with 24 hour SCH 727965 IV infusion. |
| 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1 | Experimental | Drug: SCH 727965, Drug: Aprepitant, Drug: Ondansetron, Drug: DexamethasoneParticipants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only. |
| 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2 | Experimental | Drug: SCH 727965, Drug: Aprepitant, Drug: Ondansetron, Drug: DexamethasoneParticipants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18 years, either sex, any race.
- Subjects must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
- There must be no known standard therapy, or disease must be refractory to standard therapy.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
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 727965SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial) | Drug | 2 Hour SCH 727965 infusion |
| SCH 727965SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts | Drug | 8 Hour SCH 727965 infusion |
| SCH 727965SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts | Drug | 24 Hour SCH 727965 infusion |
| SCH 727965SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle | Drug | 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2, 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1 |
| AprepitantAlso: EmendOral aprepitant in Cycle 1 or Cycle 2, depending on the study arm: 125 mg 1 hour prior to the SCH 727965 infusion on Day 1, and 80 mg on Days 2 and 3. | Drug | 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2, 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1 |
| OndansetronAlso: ZofranOndansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2. | Drug | 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2, 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1 |
| DexamethasoneAlso: DecadronOral dexamethasone in Cycles 1 and 2: 12 mg 30 minutes prior to the SCH 727965 infusion on Day 1, and 8 mg in the morning on Days 2, 3, and 4. | Drug | 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2, 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1 |
Primary outcome
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity
Time frame: End of trial
In Part 1 and Part 2, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
Time frame: Cycle 1
1 secondary outcome
In Part 3, area under the plasma concentration versus time curve and maximum concentration of SCH 727965 administered as a 2 hour intravenous infusion with or without aprepitant in participants with advanced malignancies.
Time frame: Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2
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 23 Oct 2017.
- Results publication: PubMed 23053255Zhang D, Mita M, Shapiro GI, Poon J, Small K, Tzontcheva A, Kantesaria B, Zhu Y, Bannerji R, Statkevich P. Effect of aprepitant on the pharmacokinetics of the cyclin-dependent kinase inhibitor dinaciclib in patients with advanced malignancies. Cancer Chemother Pharmacol. 2012 Dec;70(6):891-8. doi: 10.1007/s00280-012-1967-y. Epub 2012 Oct 9.
- Results publication: PubMed 28859059Mita MM, Mita AC, Moseley JL, Poon J, Small KA, Jou YM, Kirschmeier P, Zhang D, Zhu Y, Statkevich P, Sankhala KK, Sarantopoulos J, Cleary JM, Chirieac LR, Rodig SJ, Bannerji R, Shapiro GI. Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies. Br J Cancer. 2017 Oct 24;117(9):1258-1268. doi: 10.1038/bjc.2017.288. Epub 2017 Aug 31.
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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, Aprepitant and Ondansetron 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 5 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 23 Oct 2017. 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 NCT00871910, 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 23 Oct 2017.