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An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors


Phase 1
18 Years
70 Years
Not Enrolling
Both
Malignant Solid Tumour

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Trial Information

An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors


Inclusion Criteria:



- Age between 18 and 70 years, male or female.

- Histologically or cytologically confirmed malignant solid tumor that has relapsed or
is refractory to standard therapy.

- Subjects who have received prior radiation therapy with stable CNS metastasis with no
progression of brain metastasis by CT/MRI scan in last 4 weeks.

- Capable of providing informed consent and complying with trial procedures.

- ECOG performance status 0-2.

- Life expectancy >12 weeks.

- Measurable or evaluable disease according to RECIST 1.1 criteria.

- Women must not be able to become pregnant (e.g. post menopausal for at least 1 year,
surgically sterile, or practicing adequate birth control methods) for the duration of
the study.

- Women of child bearing potential must have a negative serum or urine pregnancy test
at the Screening Visit and be non-lactating.

- Geographic accessibility to the site.

Exclusion Criteria:

- Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks
prior to the Screening Visit.

- Exposure to any investigational agent within 30 days of the Screening Visit.

- Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL,
alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total
bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC)
count < 3500/mm3, absolute neutrophil count < 2000/mm3, platelet concentration <
100,000/mm3, hematocrit level < 33% for females or < 35% for males, or coagulation
tests (PT,PTT) >1.5 times the upper limit or normal.

- Clinically evident congestive heart failure > class II of the New York Heart
Association (NYHA) guidelines.

- Serious, clinically significant cardiac arrhythmias, defined as the existence of an
absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.

- History or signs of active coronary artery disease with or without angina pectoris.

- Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial
scintigram)or ultrasound determined absolute left ventricular ejection fraction
(LVEF) < 45% of predicted.

- History of HIV infection.

- Active, clinically significant serious infection requiring treatment with
antibiotics, antivirals or antifungals.

- Major surgery within 3 weeks prior to treatment.

- Substance abuse or any condition that might interfere with the subject's
participation in the study or in the evaluation of the study results.

- Any condition that is unstable and could jeopardize the subject's participation in
the study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

Safety will be based on adverse events, tolerability, physical examinations, vital signs, ECG results, laboratory test results. MTD: If 2 of 5 subjects an any dose level experiences a grade 3 or 4 non-hematologic toxicity, or a platelet count <25,000/uL or a neutrophil count <500/uL lasting >7 days and/or associated with fever >38.5C, 3 more subjects will be entered at that dose level. If 2 of 3 of the additional subjects experience any of the above adverse events, the dose level immediately below will be identified as the MTD.

Outcome Time Frame:

Up to 6 cycles (every 21 days)

Safety Issue:

Yes

Principal Investigator

Sant Chawla, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarcoma Oncology Center

Authority:

United States: Food and Drug Administration

Study ID:

INNO-206-P1-MTD-01

NCT ID:

NCT01337505

Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Malignant Solid Tumour
  • INNO-206
  • Phase 1
  • DOXO-EMCH
  • Advanced solid tumors
  • Neoplasms

Name

Location

Sarcoma Oncology CenterSanta Monica, California  90403