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Head and Neck Squamous Cell CarcinomaPhase 2NCT01807546

Oral Rigosertib for Squamous Cell Carcinoma

A Phase 2 study testing rigosertib in people with Head and Neck Squamous Cell Carcinoma and Anal Squamous Cell Carcinoma, run by Traws Pharma, Inc. at 13 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 primary objective of this study is to determine if tumors in patients with papillomavirus (HPV) positive or negative squamous cell carcinoma (SCC) that no longer responds to standard therapy will decrease in size following treatment with the investigational drug, rigosertib sodium (ON 01910.Na). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rigosertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
13 sitesUnited States
Study dates
Mar 2013to Apr 2016
Phase
Phase 2
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

  • Histologically confirmed SCC; only patients with HNSCC, non-small cell lung SCC, skin SCC, cervical SCC, penile SCC, anal SCC, or esophageal SCC;
  • For patients with HNSCC only, HPV status must be assessed by in situ hybridization (ISH) and/or p16 immunohistochemistry (IHC) according to local standards;
  • For patients with HNSCC only, HPV status must be assessed by in situ hybridization (ISH) and/or p16 immunohistochemistry (IHC) according to local standards. For all other patients with SCC originating in tissues other than the head and neck, attempts should be made to obtain HPV status;
  • Incurable, non-resectable, locally-advanced/relapsed and/or distant metastatic disease after no more than 3 prior treatment regimens, one of which must be platinum-based chemotherapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
  • Life expectancy of at least 3 months;
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  • Measurable disease according to RECIST version 1.1;
  • Ability to swallow entire capsules;
  • Adequate hematologic function;
  • Adequate hepatic function;
  • Adequate renal function;
  • Adequate contraceptive regimens for female and male patients;
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test;
  • 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).

Who cannot join

  • Chemotherapy or any potentially myelosuppressive treatment within 3 weeks prior to enrollment (6 weeks are required for nitrosoureas or mitomycin C);
  • Radiotherapy to >25% of the hematopoietic active bone marrow within 4 weeks prior to enrollment;
  • Systemic administration of corticosteroids within the past 4 weeks prior to enrollment;
  • Prior therapy with a phosphatidylinositol 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;
  • Major surgery within 3 weeks of enrollment or major surgery without full recovery;
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  • Residual clinical signs and symptoms which have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) version 4 Grade 1 severity level or below before enrollment, except for alopecia, stable residual neuropathy, and residual hand/foot syndrome;
  • Known brain metastases, except for those that have been removed or irradiated and have no current clinical impact at the time of enrollment; a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain should be obtained in patients with symptoms suggestive of brain metastases;
  • Ascites requiring active medical management, including paracentesis;
  • Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia (eg, previous syndrome of inappropriate antidiuretic hormone hypersecretion [syndrome of inappropriate antidiuretic hormone secretion (SIADH)], chronic diuretic use, etc.);
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bleeding, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia;
  • Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg;
  • New onset of seizures within 3 months prior to enrollment, or poorly controlled seizures;
  • Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements;
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rigosertib;
  • Female patients who are pregnant or lactating.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

  • Ohio State University, James Cancer Hospital

    Columbus, Ohio, 43210

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75201

  • Denver VA Medical Center-ECHCS

    Denver, Colorado, 80220

  • Veterans Administration New Jersey Health Care System

    East Orange, New Jersey, 07018

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Mount Sinai Medical Center

    New York, New York, 10029

  • University of Pennslvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Stanford Cancer Institute

    Stanford, California, 94305

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Phase II Study of Oral Rigosertib in Patients With Relapsed or Metastatic, Platinum-resistant, Human Papillomavirus Positive or Negative Squamous Cell Carcinoma

The primary objective of this study is to determine if tumors in patients with papillomavirus (HPV) positive or negative squamous cell carcinoma (SCC) that no longer responds to standard therapy will decrease in size following treatment with the investigational drug, rigosertib sodium (ON 01910.Na). A secondary objective is to determine if treatment with rigosertib causes any side effects.

Rigosertib is an investigational drug, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as a new anticancer drug. Tests that we have done in the laboratory suggest that rigosertib works by blocking cell division in cancer cells and causing them to die.

Read the detailed description

This will be a multicenter, Phase II study to evaluate the safety and efficacy of oral rigosertib in patients with relapsed or metastatic squamous cell carinoma (SCC) who previously received platinum-based chemotherapy and/or chemo-radiation therapy.

Only patients with head and neck squamous cell carinoma (HNSCC), non-small cell lung SCC, skin SCC, cervical SCC, penile SCC, anal SCC or esophageal SCC will be enrolled in the study.

Patients will be administered rigosertib capsules at a dose of 560 mg BID on days 1 to 14 of a 21-day cycle. Patients will be enrolled in 2 cohorts based on HPV test results:

  • Cohort 1 will include up to 40 patients with human papillomavirus (HPV)-positive SCC, of which approximately 30 patients will have HNSCC, and approximately 10 patients with SCC of another origin (eg, cervix, anal, penile);
  • Cohort 2 will include up to 40 patients with HPV-negative SCC, of which approximately 30 patients will have HNSCC, and approximately 10 patients with SCC of another origin (eg, lung, skin, esophageal).

Patients will be evaluated for progression after completing 3 cycles of therapy and every 3 cycles thereafter. Patients with stable disease (SD) or better, based on revised Response Criteria in Solid Tumors (mRECIST) 1.1, will receive repeated cycles of treatment on a 21-day cycle schedule until disease progression, development of unacceptable toxicity, or withdrawal of consent. Patients with progressive disease (PD) but who, in the opinion of the Investigator, appear to be deriving clinical benefit, may continue on study with a planned disease reassessment after one further cycle of therapy. Should the patient have SD or PR at this reassessment, s/he may continue on study, with subsequent reassessments every 3 cycles.

Following discontinuation of rigosertib treatment, patients' mortality status will be assessed every 3 months.

Being tested
rigosertib
Keywords
Head and neck cancer, Platinum-resistant, Squamous cell carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Anus Neoplasms, Esophageal Squamous Cell Carcinoma, 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.

  • rigosertibDrug

    Also called ON 01910.Na

    Oral rigosertib capsules at a dose of 560 mg twice a day for 14 consecutive days of a 21-day cycle (2 weeks on, 1 week off regimen).

Study groups in NCT01807546
Study groupRoleWhat they receive
rigosertibExperimentalOral rigosertib capsules at a dose of 560 mg twice a day for 14 consecutive days of a 21-day cycle (2 weeks on, 1 week off regimen).
Receives: Drug: rigosertib

What is being measured

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

  1. Overall response rate

    Outcome is defined as the number of patients with Complete Response (CR) or Partial Response (PR) per revised Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Baseline to 9 weeks after start of rigosertib treatment and every 9 weeks thereafter, up to 2 years.

Secondary outcomes (5)

  1. Overall survival (OS)

    At the time of analysis, the outcome measure will be number of days between the date the patient is enrolled in the study and the date the patient dies or date the patient is last known to be alive, up to 2 years following discontinuation of rigosertib treatment.

    Measured: Date of signing ICF to date of death, or date last known to be alive up to 2 years after discontinuation of rigosertib treatment.

  2. Progression free survival (PFS),

    At the time of analysis, the outcome measure will be number of days between the date the patient is enrolled in the study and the date that progressive disease (PD) is documented per revised Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

    Measured: 9 weeks, 18 weeks, and 27 weeks and every 9 weeks thereafter, up to 2 years after patient enrolled in the study.

  3. Concentration of rigosertib in plasma

    The concentration (expressed as microgram rigosertib per mL plasma and/or nanogram rigosertib per mL plasma) of rigosertib in plasma will be determined by a validated high performance liquid chromatography (HPLC) method.

    Measured: Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 2 Day 14 at 0, 0.5, 1, 1.5, 2, and 6 hours after the first dose of the day.

  4. Levels of Biomarkers

    Genetic and protein profiling will be conducted in blood (collected at Baseline before study drug administration) and in core biopsy or fine needle aspirate tumor samples (collected at Baseline before study drug administration and at Cycle 1 Day 14).

    Measured: Baseline ( study before drug administration) and Cycle 1, Day 14.

  5. Number of Adverse Events

    All Adverse Events reported by the patient or observed by the Investigator or study site personnel will be recorded. An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that appears or worsens in a patient during the period of observation in a clinical study.

    Measured: From signing of Informed Consent Form until 30 days after last dose of study drug.

Timeline

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

  1. First posted8 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2015
  4. Study completionApr 2016

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01807546
Sponsor's protocol ID
Onconova 09-09
Other IDs
COMIRB 13-0116
Status last verified
Jun 2017
First submitted
4 Mar 2013
Last updated
26 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Anderson RT, Keysar SB, Bowles DW, Glogowska MJ, Astling DP, Morton JJ, Le P, Umpierrez A, Eagles-Soukup J, Gan GN, Vogler BW, Sehrt D, Takimoto SM, Aisner DL, Wilhelm F, Frederick BA, Varella-Garcia M, Tan AC, Jimeno A. The dual pathway inhibitor rigosertib is effective in direct patient tumor xenografts of head and neck squamous cell carcinomas. Mol Cancer Ther. 2013 Oct;12(10):1994-2005. doi: 10.1158/1535-7163.MCT-13-0206. Epub 2013 Jul 19.

    PubMed 23873848

  • 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 2 study testing rigosertib in people with Head and Neck Squamous Cell Carcinoma and Anal Squamous Cell Carcinoma, run by Traws Pharma, Inc. at 13 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 16 inclusion and 16 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 26 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 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Overall response rate (time frame: Baseline to 9 weeks after start of rigosertib treatment and every 9 weeks thereafter, up to 2 years.). 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 NCT01807546, which also lists 2 linked publications.

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 26 Jun 2017.

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Oral Rigosertib for Squamous Cell Carcinoma | AzTrials