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Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

NCT ID: NCT00871910

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-11

Study Completion Date

2010-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors Lymphoma, Non-Hodgkin Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2 Hour SCH 727965 infusion

Participants treated with 2 hour SCH 727965 IV infusion

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)

8 Hour SCH 727965 infusion

Participants treated with 8 hour SCH 727965 IV infusion.

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts

24 Hour SCH 727965 infusion

Participants treated with 24 hour SCH 727965 IV infusion.

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts

2 Hour SCH 727965 infusions plus aprepitant in Cycle 1

Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle

Aprepitant

Intervention Type DRUG

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.

Ondansetron

Intervention Type DRUG

Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.

Dexamethasone

Intervention Type DRUG

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.

2 Hour SCH 727965 infusion plus aprepitant in Cycle 2

Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle

Aprepitant

Intervention Type DRUG

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.

Ondansetron

Intervention Type DRUG

Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.

Dexamethasone

Intervention Type DRUG

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.

Interventions

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SCH 727965

SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)

Intervention Type DRUG

SCH 727965

SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts

Intervention Type DRUG

SCH 727965

SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts

Intervention Type DRUG

SCH 727965

SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle

Intervention Type DRUG

Aprepitant

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.

Intervention Type DRUG

Ondansetron

Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.

Intervention Type DRUG

Dexamethasone

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.

Intervention Type DRUG

Other Intervention Names

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Emend Zofran Decadron

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23053255 (View on PubMed)

Mita 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.

Reference Type RESULT
PMID: 28859059 (View on PubMed)

Other Identifiers

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P04630

Identifier Type: -

Identifier Source: org_study_id