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A Phase I, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of Iso-Fludelone in Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase I, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of Iso-Fludelone in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Pathologic confirmation of malignancy at Memorial Sloan-Kettering Cancer Center

- Diagnosis of advanced stage, primary or metastatic adult solid tumors refractory to
standard therapy or for which no curative standard therapy exists

- Evidence of radiographically measurable or non-measurable disease by RECIST 1.1

- All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical
procedures must have resolved to National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE, version 4.0) Grade ≤1

- Age must be ≥ 18 years

- Last dose of antineoplastic therapy except for hormonal therapy must be > 21 days.

- Patients with brain metastasis that have been treated and clinically stable following
intervention with neurological signs or symptoms resolved to CTCAEv4 Grade ≤1

- ECOG performance status must be 0 or 1.

- Required baseline laboratory data within 14 days of iso-fludelone administration

- Hemoglobin ≥ 8.5 g/dL

- Absolute neutrophils count ≥ 1.5 x 109 /L

- Platelet count ≥ 75 x 109 /L

- Serum bilirubin < or = to 1.5 x ULN

- AST and ALT < or = to 2.5 x ULN

- Serum creatinine < or = to 1.5 x ULN

- Willing and able to comply with scheduled visits, treatment plan, and laboratory

Exclusion Criteria:

- Pre-existing diarrhea uncontrolled with supportive care. Prior hemorrhagic diarrhea
due to ulcerative colitis, inflammatory bowel disease or other cause. Active,
uncontrolled peptic ulcer disease (patients maintained with ranitidine or its
equivalent are acceptable to enroll).

- Pre-existing neurological disease (including but not limited to peripheral sensory or
motor neuropathy, seizures, gait disturbances, or tremors/involuntary movements) of
CTCAEv4 Grade ≥ 2 due to any cause.

- Hypersensitivity reaction (CTCAEv4 Grade ≥ 2) to prior therapy containing
hydroxypropyl-β-cyclodextrin, ethanol, propylene glycol, or patient may not be safely
administered ethanol (e.g., current history of ethanol abuse or concomitant
administration of Antabuse®).

- Concurrent therapy with any other investigational agent.

- Pregnant or breast-feeding women. Female patients must agree to use effective
contraception, must be surgically sterile, or must be postmenopausal. Male patients
must agree to use effective contraception or be surgically sterile. The definition
of effective contraception will be based on the judgment of the Principal
Investigator or a designated associate. All at-risk female patients must have a
negative serum pregnancy test within 10 days prior to the start of study treatment.

- Clinically significant cardiac disease (New York Heart Association, Class III or IV);
prior myocarditis from any cause; pre-existing Grade 2 or higher arrhythmias
("non-urgent medical attention indicated").

- Dementia or altered mental status that would prohibit informed consent.

- Patients with untreated central nervous system (CNS) metastases.

- Patients with known leptomeningeal metastasis

- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration or may interfere with the interpretation of study results and, in
the judgment of the Principal Investigator, would make the patient inappropriate for
this study.

- Pre-existing ophthalmologic conditions (including glaucoma; history of demyelinating
disease; vasculitis; retinal vascular occlusion and any optic neuropathy).

- History (or family history) of long QT syndrome or QTc > 450 msec on baseline ECG.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD)

Outcome Description:

The MTD is defined as the dose that results in DLT in 25% of all evaluable patients.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mrinal Gounder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Solid Tumors
  • Iso-Fludelone
  • KOS-1803
  • Dose-Escalation
  • 10-202
  • Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021