Study of PWT33597 Mesylate in Subjects With Advanced Malignancies

NCT01407380 | Completed Phase 1

• 1 other identifier: PWT33597-101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered PWT33597 mesylate in subjects with advanced malignancies.

Conditions

Malignancies

Keywords

Advanced malignancies; solid tumors; cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  2 years

Secondary Outcomes (1)

• Number of patients whose tumor show objective response or stable disease by standard criteria

  2 years

Interventions

PWT33597 mesylate DRUG

PWT33597 taken orally daily for 28 consecutive days in 28 day cycle

Eligibility Criteria

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

You may qualify if:

• Males and females ≥18 years of age.
• Pathologically confirmed advanced solid tumor or malignant lymphoma for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
• Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤1
• Evaluable disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or by the criteria of the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, or by informative tumor marker(s).
• Laboratory values at screening:
• Absolute neutrophil count ≥1,500 /mm3;
• Platelets ≥100,000/mm3;
• Total bilirubin ≤1.5 × the upper limit of normal (ULN);
• AST (SGOT) ≤2.5 × the ULN;
• ALT (SGPT) ≤2.5 × the ULN;
• Serum creatinine ≤1.5 mg/dL or a measured creatinine clearance ≥60 mL/min; and
• Negative serum beta-hCG test in women of childbearing potential (defined as women ≤50 years of age or history of amenorrhea for ≤12 months prior to study entry).
• Patients with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at screening, the following criteria are met:
• Total bilirubin is no higher than the ULN;
• AST and ALT are each ≤5 × the ULN;

You may not qualify if:

• Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids \> 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug.
• Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 1, as determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v 4.0
• Receipt of more than 5 prior regimens of cytotoxic chemotherapy unless prior approval is granted by the sponsor.
• Radiotherapy within 4 weeks prior to baseline.
• Receipt of radiotherapy to \>25 % of bone marrow.
• History of stem cell allotransplantation.
• Major surgery within 28 days prior to initiation of study drug.
• Life expectancy \<12 weeks.
• Active infection requiring systemic therapy.
• Insulin-requiring diabetes mellitus, or presence of persistent fasting blood glucose \>160 mg/dL.
• Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
• Known active hepatitis B or C or other active liver disease (other than malignancy).
• Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
• History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to \> 450 msec for males or \> 470 msec for females.
• Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.

Sponsors & Collaborators

• Pathway Therapeutics, Inc.: lead

Study Sites (4)

Pinnacle Hematology Oncology

Scottsdale, Arizona, 85258, United States

Location

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: August 2, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (4)