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Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01247246
Recruitment Status : Unknown
Verified May 2014 by SciClone Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2010
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
SciClone Pharmaceuticals

Study Description
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Brief Summary:
This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.

Condition or disease Intervention/treatment Phase
Oral Mucositis Drug: SCV-07 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy
Study Start Date : December 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo
Active Comparator: SCV-07 0.1mg/kg Drug: SCV-07
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
Active Comparator: SCV-07 0.3mg/kg Drug: SCV-07
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
Active Comparator: SCV-07 1.0mg/kg Drug: SCV-07
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy [ Time Frame: June 2012 ]
    The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.


Secondary Outcome Measures :
  1. Safety [ Time Frame: June 2012 ]
    The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB)
  • Have recently diagnosed, pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx, or larynx that will be treated with ChemoRT as first-line treatment; subjects with a history of surgical management are eligible
  • Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 50 and 72 Gy. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue, or soft palate), with each site receiving ≥ 50 Gy
  • Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

  • Have adequate hematopoietic, hepatic, and renal function at the screening visit:

    • Hematopoietic function

      • Hemoglobin ≥ 10 g/dL
      • Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3
      • Platelet count ≥ 100 × 109/L

    • Hepatic function

      • Total bilirubin < 1.5 times the upper-normal limit (ULN)
      • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
    • Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min
  • Have a negative serum pregnancy test if a woman is of childbearing potential
  • Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential
  • Males or females aged 18 years or older.

Exclusion Criteria:

  • Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
  • Metastatic disease (M1) Stage IV C
  • Prior radiation to the head and neck
  • Plan to be treated with cetuximab (Erbitux®)
  • Have undergone induction CT
  • History of other malignant tumors, excluding non-melanoma skin cancer or curatively excised in situ cervical carcinoma
  • Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the study
  • Active infectious disease, excluding oral candidiasis
  • Have OM at the baseline visit
  • Have a diagnosis of autoimmune disease requiring chronic immunosuppression
  • Known seropositivity for HIV, HBV, or HCV
  • Prior use of SCV 07
  • Have used any investigational agent within 30 days of randomization
  • Are pregnant or breastfeeding
  • Known allergies or intolerance to cisplatin
  • Unable to give informed consent or comply with study requirements, including completing the subject diary and QOL instruments
  • Have any other condition or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with follow-up visits.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247246


Locations
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Sponsors and Collaborators
SciClone Pharmaceuticals
Investigators
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Study Director: Israel Rios, MD SciClone Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: SciClone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01247246    
Other Study ID Numbers: SCI-SCV-MUC-P2b-002
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014
Keywords provided by SciClone Pharmaceuticals:
Oral Mucositis
Head and Neck
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
SCV-07
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases