Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck

NCT01527877 | Unknown Phase 2 DMC

• 1 other identifier: 2011-0828-001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate disease control rate (DCR) at 8 weeks of BKM120 administered as therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma.

Conditions

Head Neck Cancer Squamous Cell Metastatic; Head Neck Cancer Squamous Cell Recurrent

Keywords

BKM120; head and neck cancer; squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate at 8 weeks

  The disease control rate (DCR) is defined as the proportion of randomized patients achieving a best overall response of PR or CR or SD, defined by RECIST criteria (version 1.1), relative to the total number of patients in the considered analysis population (ITT).

  Eight weeks after administration of the drug

Secondary Outcomes (6)

• Overall response rate (ORR)

  Every 8 weeks from date of first treatment until date of last treatment up to 24 months

• Toxicity profile

  Every 4 weeks from date of first treatment until date of last treatment up to 24 months

• Overall survival

  Every 8 weeks from date of first treatment until the date of death from any cause, assessed approximately up to 24 months

• Progression-free survival

  Every 8 weeks from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 24 months

• Quality of life assessment

  Every 4 weeks from date of first treatment until the date of death from any cause, assessed approximately up to 24 months

Study Arms (1)

BKM120

EXPERIMENTAL

Drug: BKM120

Interventions

BKM120 DRUG

Patients will be instructed to take BKM120 orally at a dose of 100 mg with a glass of water once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day. The patient will be dosed on a flat scale of mg/day and not be adjusted to body weight or body surface area. If vomiting occurs no attempt should be made to replace the dose. • BKM120 should be taken 1-hour following a light meal. Please note that patients must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period due to potential CYP3A4 interaction. Regular orange juice is allowed.

Also known as: NVP-BKM120, BKM-120

BKM120

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed recurrent or metastatic squamous-cell carcinoma of head and neck (SCCHN), except nasopharyngeal carcinoma
• Disease not amenable to curative treatment (surgery or radiation for curative intent)
• years of age or older
• Progressive disease defined as follows
• after one or two prior chemotherapy regimens including platinum-based chemotherapy given for palliation
• within 6 months after concurrent chemoradiotherapy (including induction chemotherapy) delivered as part of primary treatment.
• Life expectancy of at least 12 weeks
• At least one measurable lesion according to the RECIST 1.1 criteria.
• ECOG performance score of 0 \~ 2
• Adequate organ function
• Absolutely Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hemoglobin ≥ 9.0 g/dL
• Serum Creatinine ≤ 1.5 x ULN
• Adequate liver function (total bilirubin ≤ 2.0 x ULN, AST and ALT ≤ 2.0 x ULN or \< 5.0 x ULN if liver metastases are present)
• Availability of tissue samples (archival tissue or rebiopsied tissues) for molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
• Patients who have will and ability to comply with the scheduled visits, the treatment plan, laboratory tests and any other trial procedures

You may not qualify if:

• Nasopharyngeal carcinoma
• More than two prior lines of chemotherapy in the palliative setting.
• Uncontrolled, untreated brain metastasis Patients with controlled and asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases ≥ 28 days (must include radiotherapy and/or surgery) and, if on corticosteroid therapy, should be receiving a stable low dose (e.g. dexamethasone 4 mg or equivalent dose of another corticosteroid for at least 14 days before start of study treatment)
• Surgery, chemotherapy or irradiation within 4 weeks of study entry
• Prior treatment with any investigational drug within the preceding 4 weeks
• Concomitant chemotherapy, hormonal therapy or immunotherapy
• Previous or concomitant malignant disease, except adequately treated basal cell cancer of the skin or cervical cancer in situ, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated \> 5 years prior study entry
• Patient who cannot take the oral drug
• Patient is pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).
• Clinically significant psychological disorders including mood and anxiety disorders judged by psychiatry physician
• Patient who have not recovered to grade 1 or better from any adverse events (except alopecia) related to previous antineoplastic therapy before screening procedures are initiated
• Severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
• Patient has poorly controlled diabetes mellitus (HbA1c\> 8 %)
• Patient has history of cardiac dysfunction including history of documented congestive heart failure (New York Heart Association functional classification III-IV) and documented cardiomyopathy
• Patient is currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes. \* Active infection, inflammatory bowel disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Kim HR, Kang HN, Yun MR, Ju KY, Choi JW, Jung DM, Pyo KH, Hong MH, Ahn MJ, Sun JM, Kim HS, Kim J, Yoo J, Kim KR, Koh YW, Kim SH, Choi EC, Yoon SO, Shim HS, Paik S, Kim TM, Cho BC. Mouse-human co-clinical trials demonstrate superior anti-tumour effects of buparlisib (BKM120) and cetuximab combination in squamous cell carcinoma of head and neck. Br J Cancer. 2020 Dec;123(12):1720-1729. doi: 10.1038/s41416-020-01074-2. Epub 2020 Sep 23.

  PMID: 32963347 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Byoung Chul Cho, M.D., Ph.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byoung Chul Cho, M.D., Ph.D.

CONTACT

82-2-2228-8126; cbc1971@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: February 7, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: October 8, 2012

Record last verified: 2012-10

Locations

KR (1)