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Head and Neck NeoplasmsPhase 1NCT02107235

Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer

A Phase 1 study testing oral rigosertib, cisplatin and Radiotherapy in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by Traws Pharma, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The working hypothesis is that oral rigosertib treatment when added to platinum-based Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck Squamous Cell Carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
oral rigosertib, cisplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
4 sitesUnited States
Study dates
Jan 2014to Jan 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed diagnosis of Squamous Cell Carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal wall), hypopharynx, or larynx.
  • Patient is an appropriate candidate for definitive chemoradiotherapy.
  • Intermediate-risk Head and Neck Squamous Cell Carcinoma (HNSCC), defined as follows:
  • Clinical stage T2-4, N2a-N3 or T3-4, N0-N3
  • P16 (+) by immunohistochemistry (IHC) or HPV (+) by in situ hybridization (ISH)
  • Smoking status of ≥ 10 pack-years, or < 10 pack-years and T4 or N2c-N3.
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  • If not intermediate-risk HNSCC, is high-risk HNSCC, defined as follows:
  • Clinical stage T2-4, N2a-N3 or T3-4, N0-N3.
  • P16 (-) by IHC or HPV (-) by ISH.
  • No evidence of distant metastases.
  • Clinically or radiographically evident measurable disease (as defined by RECIST v 1.1) at the primary site or nodal stations.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematologic function as defined by absolute neutrophil count (ANC) ≥ 1800/μL; platelet (PLT) ≥ 100,000/μL; Hgb ≥ 8.0 g/dL.
  • Adequate renal function, as defined by serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min.
  • Adequate liver function as defined by total bilirubin ≤ 1.5 x ULN; aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 x ULN; and prothrombin time ≤ 1.5 x ULN, unless receiving therapeutic anticoagulation.
  • Ability to understand the nature of the study and any hazards of study participation, to communicate satisfactorily with the Investigator, and to follow the requirements of the entire protocol.
  • Willingness to adhere to the prohibitions and restrictions specified in this protocol.
  • The patient must sign an informed consent form (ICF) indicating that s/he understands the purpose of and procedures required for the study and is willing to participate in the study.

Who cannot join

  • Gross total excision of the primary and nodal disease.
  • Prior treatment with IV or oral rigosertib.
  • Prior chemotherapy for the study HNSCC cancer.
  • Prior radiotherapy to the region of the study HNSCC cancer or adjacent anatomical sites, or to > 25% of marrow-bearing area.
  • Synchronous malignancies.
  • Prior invasive malignancy unless the patient is disease-free for a minimum of 3 years; however, patients with prior non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or prostate cancer with undetectable prostate-specific antigen (PSA) may be enrolled.
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  • Severe, active comorbidity.
  • Known infection with human immunodeficiency virus (HIV).
  • Any uncontrolled condition that, in the opinion of the Investigator, could affect the subject's participation in the study.
  • Major surgery within 3 weeks of enrollment or major surgery without full recovery.
  • Ascites requiring active medical management, including paracentesis.
  • Hyponatremia (defined as serum sodium < 130 milliequivalent mEq/L) or conditions that may predispose patients to hyponatremia.
  • Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 110 mmHg, despite treatment with 2 antihypertensive agents.
  • New onset of seizures within 3 months prior to enrollment, or poorly controlled seizures.
  • Female patients who are pregnant or lactating.
  • Female patients of childbearing potential and male patients with partners of childbearing potential who are unwilling to follow strict contraception requirements.
  • Female patients of childbearing potential who do not have a negative blood or urine pregnancy test at Screening.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rigosertib.
  • Prior therapy with a phosphatidyl-inositol 3 kinase (PI3K), Akt or mammalian target of rapamycin (mTOR) inhibitor.
  • Any other investigational agent or chemotherapy, radiotherapy, or immunotherapy within 4 weeks of enrollment.
  • Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Phase I Study of Platinum-based Chemoradiotherapy (CRT) With Oral Rigosertib in Patients With Intermediate or High-risk Head and Neck Squamous Cell Carcinoma

The working hypothesis is that oral rigosertib treatment when added to platinum-based Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib that can be used with cisplatin and CRT. This study will also record any side effects that may occur and measure tumor sizes and how long patients live.

Read the detailed description

This is a multicenter, dose-escalating study of oral rigosertib administered with concurrent cisplatin and Radiotherapy in patients with intermediate- and high-risk Head and Neck Squamous Cell Carcinoma.

Three rigosertib escalating cohorts (up to 6 patients per cohort) will be sequentially evaluated: 70 mg 3 times a day (TID), 140 mg TID and 280 mg TID. The total treatment course will be 8 weeks: 1 week of oral rigosertib alone (70 mg TID, 140 mg TID or 280 mg TID) followed by 7 weeks of concurrent administration of rigosertib, cisplatin and radiation therapy.

After completion of treatment, patients will be followed for up to 36 months to document Progression-free Survival and Overall Survival.

Being tested
oral rigosertib, cisplatin, Radiotherapy
Keywords
Chemoradiotherapy, cisplatin
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral rigosertibDrug

    Also called ON 01910.Na, rigosertib sodium

  • cisplatinDrug

  • RadiotherapyRadiation

Study groups in NCT02107235
Study groupRoleWhat they receive
Rigosertib + Cisplatin + RadiationExperimentalOral rigosertib will be started 7 days before initiation of concurrent treatment with cisplatin and radiation therapy and will be administered on a continuous basis for a fixed duration of 8 weeks. Three oral rigosertib escalating doses will be sequentially evaluated: 70 mg 3 times a day (TID), 140 mg TID and 280 mg TID. Cisplatin will be administered intravenously at a dose of 40 mg/m^2 on Days 1, 8, 15, 22, 29, 36, and 43 of the 7-week concurrent treatment course. The prescribed radiotherapy dose will be 70 Gray (Gy) in 2 Gy once-daily fraction size (total of 35 fractions) over the 7-week concurrent treatment course. The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, 5 fractions per week.
Receives: Drug: oral rigosertib; Drug: cisplatin; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients who experience dose limiting toxicities

    The primary objective of the study is to determine the maximum tolerated dose (MTD) of oral rigosertib when administered with platinum-based chemoradiotherapy to patients with intermediate- and high-risk Head and Neck Squamous Cell Carcinoma. The MTD is defined as the dose level immediately below that at which 2 or more patients experience a dose limiting toxicity (DLT).

    Measured: Up to 12 weeks

Secondary outcomes (2)

  1. Number of patients who experience adverse events

    Measured: Up to 14 weeks

  2. Number of patients who achieve a complete response or a partial response

    Complete response (CR) and Partial response (PR) are evaluated according to "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)." European Journal of Cancer, 45 (2009) 228-247.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107235
Sponsor's protocol ID
Onconova 09-12
Status last verified
Jun 2017
First submitted
3 Apr 2014
Last updated
23 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing oral rigosertib, cisplatin and Radiotherapy in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by Traws Pharma, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients who experience dose limiting toxicities (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.

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