A Study of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (P04722) - Full Text View

Purpose

This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label trial designed to evaluate the safety and tolerability of SCH 717454 in combination with standard treatment in subjects with advanced solid tumors to be conducted in conformance with Good Clinical Practices.

Six different treatment regimens will be investigated in combination with SCH 717454.

The study will be divided into two parts. Part 1 will consist of initial safety evaluation and dose-finding of SCH 717454 in combination with each treatment regimen. Part 2 will consist of an expansion of each SCH 717454 regimen at a newly established dose level, to better define safety, tolerability, and initial efficacy in specific target populations.

Condition	Intervention	Phase
Neoplasms	Drug: Regimen A: FOLFIRI (± Cetuximab), and SCH 717454 Drug: Regimen B: Carboplatin, Paclitaxel, and SCH 717454 Drug: Regimen C: Epirubicin, Cisplatin, 5-FU, and SCH 717454 Drug: Regimen D: Trastuzumab and SCH 717454 Drug: Regimen E: mTor Inhibitor (Everolimus) and SCH 717454 Drug: Regimen F: Gemcitabine (± Erlotinib), and SCH 717454	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (Phase 1B/2; Protocol No. P04722)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Cisplatin Paclitaxel Carboplatin Sirolimus Epirubicin hydrochloride Epirubicin Gemcitabine Gemcitabine hydrochloride Everolimus Temsirolimus Trastuzumab Erlotinib hydrochloride Erlotinib Cetuximab

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

For Part 2: The Primary Efficacy Endpoint for the current trial is the RECIST-determined response rate. [ Time Frame: Approximately 30 days after the final dose of SCH 717454 or the standard treatment assigned (whichever is last). ] [ Designated as safety issue: No ]
For Part 1: Summaries of dose limiting toxicities, all adverse events, and laboratory results will be provided for the MAD. Adverse events and laboratory results will be tabulated by dose level for each regimen. Electrocardiograms will be summarized. [ Time Frame: Approximately 30 days after the final dose of SCH 717454 or the standard treatment assigned (whichever is last). ] [ Designated as safety issue: Yes ]

Enrollment:	15
Study Start Date:	September 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Regimen A: FOLFIRI (± Cetuximab), and SCH 717454	Drug: Regimen A: FOLFIRI (± Cetuximab), and SCH 717454 FOLFIRI (Irinotecan, Folinic Acid and 5-fluorouracil [5-FU]) will be administered in a 14-day cycle with SCH 717454 (± Cetuximab)
Experimental: Regimen B: Carboplatin, Paclitaxel, and SCH 717454	Drug: Regimen B: Carboplatin, Paclitaxel, and SCH 717454 On Day 1 of treatment, carboplatin will be administered with paclitaxel and with SCH 717454. One cycle will be defined as 3 weeks.
Experimental: Regimen C: Epirubicin, Cisplatin, 5-FU, and SCH 717454	Drug: Regimen C: Epirubicin, Cisplatin, 5-FU, and SCH 717454 Epirubicin, cisplatin, and SCH 717454 will be administered on Day 1, and 5-FU will be administered via a 21-week continuous IV infusion. One cycle will be defined as 3 weeks.
Experimental: Regimen D: Trastuzumab and SCH 717454	Drug: Regimen D: Trastuzumab and SCH 717454 Trastuzumab will be given on Day 1, Day 8, Day 15, and Day 22 with SCH 717454. One cycle will be defined as 4 weeks.
Experimental: Regimen E: mTor Inhibitor (Everolimus) and SCH 717454	Drug: Regimen E: mTor Inhibitor (Everolimus) and SCH 717454 Everolimus orally once per day, starting on Day 1 of Cycle 1 with SCH 717454. One cycle will be defined as 4 weeks.
Experimental: Regimen F: Gemcitabine (± Erlotinib), and SCH 717454	Drug: Regimen F: Gemcitabine (± Erlotinib), and SCH 717454 Gemcitabine will be administered on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest in Cycle 1 (8 weeks). For subsequent cycles, gemcitabine will be administered on Days 1, 8, and 15 in subsequent 4 week cycles. SCH 717454 will be administered with the regimen.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Each subject must be willing and able to provide written informed consent for the trial.
Each subject must be ±18 years of age. A subject may be of either sex and of any race/ethnicity;
Part 1: Each subject must have a histologically or cytologically confirmed advanced malignant solid tumor;
Part 2: Each subject must have a histologically or cytologically confirmed, with measurable disease (as defined by RECIST), advanced, malignant solid tumor.
Each subject must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <=2.
Each subject must have adequate organ function within 3 weeks prior to first study drug administration.

Exclusion Criteria:

A subject must not have known treated or untreated leptomeningeal metastasis or a metastatic central nervous system lesion.
A subject must not have a history of another malignancy
A subject must not have received prior therapy with any anti-IGF-1R monoclonal antibody.
A subject must not have received radiation therapy within 2 weeks prior to first study drug administration.
A subject must not have received radiation therapy to >25% of his/her total bone marrow during his/her lifetime.
A subject must not have undergone major surgery within 3 weeks prior to first study drug administration.
A subject must not have known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy.
A subject must not have known active hepatitis B or C.
A subject must not have any serious or uncontrolled infection.
A subject must not have uncontrolled diabetes mellitus.
A subject must not have had any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00954512 History of Changes
Other Study ID Numbers:	P04722
Study First Received:	July 23, 2009
Last Updated:	February 21, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Antibodies, neoplasm

Additional relevant MeSH terms:

Neoplasms
Gemcitabine
Trastuzumab
Cetuximab
Cisplatin
Epirubicin
Fluorouracil
Sirolimus
Carboplatin
Paclitaxel
Everolimus
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Antifungal Agents
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on June 17, 2013