Efficacy Study Of P276-00 In Subjects Of Malignant Melanoma Positive For Cyclin D1 Expression

NCT00835419 | Completed Phase 2

• 1 other identifier: P276-00/27/08
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 7

Brief Summary

The purpose of this study is to evaluate efficacy of P276-00 in subjects with advanced malignant melanoma positive for cyclin D1 expression

Conditions

Melanoma

Keywords

metastatic malignant melanoma with cyclin D1 positivity

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival rate at Day 168

  168 days

Secondary Outcomes (1)

• Overall survival rate at 1 year, objective response rate,duration of response

  1 year

Study Arms (1)

1

EXPERIMENTAL

P276-00 investigational product (small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor)

Drug: P276-00

Interventions

P276-00 DRUG

P276-00 -small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with histologically confirmed stage III (unresectable) or stage IV metastatic melanoma as per revised AJCC melanoma staging
• Subject positive for cyclin D1 expression by appropriate technique
• Subject with at least one metastasis in which surgery was not a curative option and had relapsed from, or had not responded to at least one regimen containing Dacarbazine and or IL-2
• Subjects with measurable disease \[at least one unidimensionally measurable lesion ³ 20 mm with conventional techniques (CT, MRI, X-ray) or ³ 10 mm by spiral CT scan\]
• Subject of either sex and 18 years of age or elder
• Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
• Subject with life expectancy of at least 4 months
• Subject must have normal organ and marrow function as defined below
• Hemoglobin ≥ 9 g/dL
• Absolute Neutrophil count ≥ 1,500/mm3
• Platelets ≥ 100,000/mm3
• Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
• AST/ALT ≤ 2.5 X institutional ULN or ≤ 5 X ULN if liver function abnormalities are due to underlying malignancy
• S. creatinine within 1.5 times the upper normal institutional limits
• Subjects with metastatic disease to the central nervous system will be included provided they had either:

You may not qualify if:

• Treatment with P276?00 or other cyclin dependent kinase (CDK) targeting agents anytime in the past
• History of allergic reactions attributed to compounds of chemical composition similar to P276?00
• Subject who have had chemotherapy, immunotherapy or radiotherapy within 4 week prior to first dosing of study agent. For nitrosoureas, there shall be interval of at least six week from first dosing of study agent
• Subject who have not recovered from adverse events (AE ³ CTCAE Grade 2) due to agents administered more than 4 week earlier.
• Subject who had received any other investigational drug within 1 month prior to day 1 of study drug administration
• Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years
• Any medical condition (such as but not limited to severe/unstable angina, history of myocardial infarction, coronary/peripheral artery bypass graft, symptomatic congestive cardiac failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism) or laboratory abnormality(ies) which might make it difficult for the subject to participate in the study, at the discretion of the Principal Investigator (PI)or co-PI
• Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness
• QTc \> 470 millisecond on 12 lead Electrocardiogram at screening
• Pregnant or nursing women
• Women of childbearing potential \[defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)\] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) after signing an informed consent document (ICD), during the duration of study participation and for at least 4 week after withdrawal from the study, unless they are surgically sterilized

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

Study Sites (7)

University of Newcastle, School of Medicine and Public Health

Newcastle, New South Wales, 2300, Australia

Location

Mater Adult Hospital Raymond Tce South Brisbane, QLD 4101

Brisbane, Australia

Location

Peninsula Oncology Centre

Frankston, 3199, Australia

Location

John Fawkner Cancer Trial Centre

Victoria, 3058, Australia

Location

Curie Manavata Cancer Center

Nashik, Maharashtra, 422 004, India

Location

Chhatrapati Shahuji Maharaj Medical University

Lucknow, Uttar Pradesh, 22600, India

Location

Christchurch Oncology Research Unit, Oncology Service, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, Christchurch,

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Melanoma

Interventions

P276-00

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Hersey, MD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

IN (2); NZ (1); AU (4)