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Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytRx
ClinicalTrials.gov Identifier:
NCT01337505
First received: April 14, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.


Condition Intervention Phase
Malignant Solid Tumour
 Drug: INNO-206
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by CytRx:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 6 cycles (every 21 days) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 6 cycles (every 21 days) ] [ Designated as safety issue: No ]
    To evaluate the objective response reate (OR; RECIST 1.1 criteria). Changes in tumor measurements from baseline values that are confirmed by repeat assessments will be assigned a status of CR or PR. OR=CR+PR.


Enrollment: 24
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INNO-206
INNO-206 at dosages of 230, 350, and 450 mg/m2 doxorubicin equivalents of 165, 260, and 325 mg/m2)will be administered as a 30 minute IVI on Day 1 of each cycle.
 Drug: INNO-206
INNO-206 at dosages of 230, 350, and 450 mg/m2 (doxorubicin equivalents of 165, 260, and 325 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle.
Other Name: DOXO-EMCH

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337505

Locations
United States, California
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Sponsors and Collaborators
CytRx
Investigators
Principal Investigator: Sant Chawla, M.D. Sarcoma Oncology Center
  More Information

No publications provided

Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT01337505     History of Changes
Other Study ID Numbers: INNO-206-P1-MTD-01
Study First Received: April 14, 2011
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CytRx:
INNO-206
Phase 1
DOXO-EMCH
Advanced solid tumors

Additional relevant MeSH terms:
Neoplasms
Doxorubicin
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013