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

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 |
- 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.
- Safety [ Time Frame: June 2012 ]The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Have adequate hematopoietic, hepatic, and renal function at the screening visit:
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Hematopoietic function
- Hemoglobin ≥ 10 g/dL
- Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3
- Platelet count ≥ 100 × 109/L
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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
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- 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.

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

Study Director: | Israel Rios, MD | SciClone Pharmaceuticals |
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 |
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 |
Head and Neck Neoplasms Mucositis Stomatitis Neoplasms by Site Neoplasms |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases |