Cardiac Safety Assessment Study of Picoplatin in Solid Tumors

NCT00710697 | Unknown Phase 1

• 1 other identifier: 0701
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm.

Conditions

Solid Tumors

Keywords

Bladder Cancer; Breast Cancer; Colorectal Cancer; Gastrointestinal Neoplasm; Head and Neck Cancer; Lung Cancer; Ovarian Cancer; Pancreatic Cancer; Prostrate Cancer

Outcome Measures

Primary Outcomes (1)

• ECG interval change

  24 hours

Secondary Outcomes (1)

• Safety/Efficacy

  24 hours

Study Arms (1)

Single Arm

EXPERIMENTAL

Picoplatin

Drug: Picoplatin

Interventions

Picoplatin DRUG

IV 150 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Single Arm

Eligibility Criteria

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

You may qualify if:

• Documented histological or cytological diagnosis of non-hematological malignancy.
• Subjects for whom, in the opinion of the investigator, treatment with single agent picoplatin is appropriate.
• years of age or older.
• ECOG performance status 0-2.
• An acceptable screening ECG.
• The following laboratory values:
• ANC ≥ 1500 cells/mm3 (without use of myeloid growth factors).
• Hemoglobin ≥ 10.0 g/dL (may be achieved with transfusion or growth factors).
• Platelet count ≥ 100,000/mm3 (without platelet transfusions in the past 10 days).
• Serum creatinine ≤ 1.5 x ULN.
• Total bilirubin ≤ 1.5 x ULN.
• AST/SGOT and ALT/SGPT ≤ 2.5 x ULN (up to 5.0 x ULN in the event of documented hepatic tumor involvement).
• Serum potassium and magnesium within institutional normal limits. PT, aPTT ≤ 1.2 x ULN.
• Recovery period ≥ 4 weeks since major surgery, any chemotherapy (≥ 6 weeks for treatment with mitomycin or any nitrosourea), any biological therapy, any investigational therapy or any change in usage of "alternative therapies".
• Recovery period ≥ 2 weeks since any radiation therapy.

You may not qualify if:

• Symptomatic or uncontrolled brain metastases.
• Use of conventional granulocyte growth factors within the preceding 10 days or pegfilgrastim within the past 21 days.
• Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example,
• Unresolved toxicities from prior treatments of \> Grade 1 (other than alopecia).
• Clinically significant infection.
• Known viral infections with hepatitis B or C or HIV.
• Clinically significant psychiatric illness.
• Any other systemic or localized disease or therapy likely to interfere with tolerance of chemotherapy or requirements of study participation.
• History of unexplained syncope within the last two months or a family history of sudden unexplained death.
• Cardiac contraindications to study participation, including:
• History of serious cardiac disease, defined as myocardial infarction within three months of enrollment, congestive heart failure classified by the New York Heart Association as Class III or IV, clinically significant cardiac arrhythmias, poorly controlled or unstable angina or electrocardiographic evidence of acute ischemia.
• Implantable pacemaker or automatic implantable cardioverter defibrillator.
• Congenital long QT syndrome or family history of long QT syndrome.
• If male, QTc \> 450 ms; if female, QTc \> 460 ms.
• PR duration \> 240 ms; QRS \> 110 ms. Complex arrhythmias (significant ventricular tachycardia, Mobitz block, bifascicular AV block) on the screening ECG.

Sponsors & Collaborators

• Poniard Pharmaceuticals: lead

Study Sites (7)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85258, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Georgia Cancer Specialists

Atlanta, Georgia, 30341, United States

Location

UNM Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Northwest Medical Specialities

Tacoma, Washington, 98405, United States

Location

Related Links

• Sponsors website

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms

Interventions

amminedichloro(2-methylpyridine)platinum(II)

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases

Study Officials

• Robert Earhart, MD, PhD

  Poniard Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 24, 2009

Record last verified: 2009-09

Locations

US (7)