A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors

Status unconfirmed · Phase 1

Conditions studied: Solid Tumors

In brief

The Primary objective of this study is: 1\. To determine the cardiac safety of TH-302 in patients with advanced solid tumors The Secondary objectives are: 1. To assess the pharmacokinetics (PK) of TH-302 2. To evaluate whether there is an association between plasma exposure to TH-302 and its active metabolite, Br-IPM, and effects on cardiac repolarization 3. To assess the safety and antitumor activity of TH-302 in patients with advanced solid tumors

Key facts

Study ID

NCT02020226

Run by

Threshold Pharmaceuticals

People needed

40

Starts

2013-11-01

Expected to finish

2016-12-01

Last updated by the study team

2016-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female patients at least 18 years of age
• Advanced solid tumor for which no other higher priority therapies are available
• ECOG performance status of ) to 1
• Measurable or evaluable disease by RECIST 1.1
• Refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival at least 3 months
• At least 3 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, which ever is shorter, after targeted or biologic therapy
• Acceptable renal function defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60mL/min (by Cockcroft Gault formula)
• Acceptable liver function defined as:
• Bilirubin ≤ 1.5 x upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
• AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN); if liver metastases are present, then ≤ 5 x ULN is allowed
• Adequate bone marrow function (Absolute neutrophil count (ANC) ≥ 1,500 cells/uL; Platelets (PLT) ≥ 100,000 cells/uL)
• Adequate cardiac conduction by ECG without evidence of second- or third-degree atrioventricular block and meeting all of the following ECG criteria:
• Heart rate 45-100 beats per minute
• No evidence of second- or third-degree atrioventricular block
• QRS interval ≤ 110ms
• QT interval corrected for heart rate by Fridericia's formula (QTcF) ≤ 480ms
• PR interval ≤ 200ms
• No arrhythmia interpreted by the study cardiologist to be clinically significant
• Female patients of childbearing age must have a negative serum HCG test unless prior hysterectomy or menopause (defined as age ≥ 55 and twelve consecutive months without menstrual activity). Female patients should not become pregnant or breast-feed while on this study. Sexually active male and female patients should use effective birth control

You may not qualify if…

• Receiving QT-prolonging drugs with a risk of causing torsades de pointes (TdP), unless ECG meets inclusion criteria on a stable dose of the drug and with discussion and agreement with the project clinician
• History of risk factors for TdP, including family history of long QT syndrome
• Sustained systolic blood pressure (BP) >140 mm Hg or <90 mm Hg, diastolic BP >100 mm Hg or <60 mm Hg
• Uncontrolled intercurrent illness, including, but not limited to, myocardial infarction within 6 months, unstable symptomatic ischemic heart disease, active uncontrolled infection requiring systemic therapy, or psychiatric illness/social situations that would limit compliance with study requirements
• Major surgery within the 28 days preceding the first dose of study drug
• Newly diagnosed or uncontrolled cancer-related central nervous system disease
• Receiving medications that are moderate or strong inhibitors or inducers of CYP3A4 or that are sensitive substrate or substrates with a narrow therapeutic index of CYP3A4, CYP2D6, or CYP2C9 (see Appendix D)
• Unwillingness or inability to provide written informed consent and comply with the study protocol for any reason

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• Yuma Regional Cancer Center — Yuma, Arizona, United States

Full record on ClinicalTrials.gov

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