Malignant Solid TumorPhase 1/2NCT01309490
Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients
A Phase 1/2 study testing Ribavirin in people with Malignant Solid Tumor, run by Jewish General Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to learn whether oral Ribavirin is safe and effective in treating patients with solid tumour cancers, that have high levels of the protein eIF4E. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2011to 29 Oct 2014
- Phase
- Phase 1/2
- 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
- Phase I part of study : Histologically or cytologically confirmed cancer at diagnosis, with advanced, incurable disease at the time of screening, who have progressed on or are not suitable for standard therapy.
- Phase II part of study: Histologically or cytologically confirmed BC or HNSCC at diagnosis, with advanced, incurable disease at the time of screening, who have progressed on or are not suitable for standard therapy.
- Willing to have a screening biopsy performed from an easily accessible lesion (ex. skin, superficial lymph node) AND whose tumour must overexpress eIF4E.
- Easily accessible lesion for serial biopsies (ex. skin, superficial lymph node, or other easily accessible site).
- At least 1 unidimensionally measurable lesion (based on the RECIST criteria) outside the CNS.
- ECOG 0, 1, or 2.
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- Adequate recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy.
- Adequate wash-out period from last therapy (at least 3 weeks).
- Life expectancy ≥ 12 weeks.
- Age ≥ 18 years old.
- Female patients of childbearing potential must have a negative serum (beta-HCG) pregnancy test within 14 days of starting protocol and must not be breastfeeding. Men and women of childbearing potential (including men who have had a vasectomy and women who have had tubal ligation) must agree to use two effective means of contraception throughout the study and for at least 6 months after completion of protocol. Post-menopausal women (defined as 12 or more consecutive months of amenorrhea, or follicle stimulating hormone (FSH) in the post-menopausal range), or surgically sterile women (defined as removal of the uterus or ovaries), do not require methods of contraception.
- Adequate renal and hepatic function: serum creatinine < 1.5 x ULN; AST or ALT < 2.5 x ULN (or < 5 x ULN if liver involvement with metastases); serum bilirubin < 1.5 x ULN.
- Adequate hematopoietic function: neutrophils ≥ 1.0 x 109/L, platelets ≥ 75 x 109/L.
- Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained.
- Accessible for treatment and follow up.
Who cannot join
- Symptomatic brain metastases.
- Active cardiovascular disease as defined by New York Heart Association (NYHA) class III-IV categorization.
- Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up.
- Use of any investigational anti-cancer drug within 2 weeks before start of study treatment or inadequate recovery from any toxic effects of such therapy.
- Female patients who are pregnant or breastfeeding.
- Concurrent treatment with other anti-cancer therapy. Bisphosphonates are allowed as long as they were started prior to screening (at least 4 weeks before study entry).
- Known infection with HIV.
- History of other malignancy in the past 5 years. Subjects who have been disease-free for 1 year or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Dose Escalation Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients Expressing Elevated eIF4E
The purpose of this study is to learn whether oral Ribavirin is safe and effective in treating patients with solid tumour cancers, that have high levels of the protein eIF4E.
Read the detailed description
This is a dose escalating, open-label, Phase I/II study of single agent oral ribavirin administered daily in solid tumour cancer patients who have failed standard treatments, overexpress eIF4E, and have easily accessible disease for serial biopsies.
- Conditions
- Malignant Solid Tumor
- Being tested
- Ribavirin
- Keywords
- high eIF4E expression, solid tumor cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Dose Level: 1 1400 mg po BID Dose Level: 2 1800 mg po BID Dose Level: 3 2200 mg po BID Dose Level: 4 2600 mg po BID Dose Level: 5 3000 mg po BID
| Study group | Role | What they receive |
|---|---|---|
| Ribavirin, nucleoside analog | Experimental | Not described Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D)
Measured: Average 1.5 years
Phase II: Determine the overall response rate to therapy with ribavirin
Measured: Average 1.5 years
Secondary outcomes (7)
Incidence and nature of DLTs
Measured: 3 years
Incidence, nature and severity of adverse events
Measured: 3 years
Time to and duration of response, defined as the first occurence of documented objective response until the time of recurrence or death from any cause
Measured: 3 years
Clinical benefit rate, defined as the overall response rate and stable disease for greater than or equal to 24 weeks
Measured: 3 years
Pharmacokinetic parameters of ribavirin determine by total exposure, maximum plasma concentration, etc.
Measured: 3 years
Correlation between eIF4E activity and response
Measured: 3 years
To determine the effect of ribavirin on the activity of eIF4E related pathways through correlative studies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study start17 Mar 2011
- Primary completion29 Oct 2014
- Study completion29 Oct 2014
Why it stopped: Low accrual, competing studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Miller, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309490
- Sponsor's protocol ID
- Ribavirin-004
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2011
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Assouline S, Culjkovic B, Cocolakis E, Rousseau C, Beslu N, Amri A, Caplan S, Leber B, Roy DC, Miller WH Jr, Borden KL. Molecular targeting of the oncogene eIF4E in acute myeloid leukemia (AML): a proof-of-principle clinical trial with ribavirin. Blood. 2009 Jul 9;114(2):257-60. doi: 10.1182/blood-2009-02-205153. Epub 2009 May 11.
PubMed 19433856Kentsis A, Topisirovic I, Culjkovic B, Shao L, Borden KL. Ribavirin suppresses eIF4E-mediated oncogenic transformation by physical mimicry of the 7-methyl guanosine mRNA cap. Proc Natl Acad Sci U S A. 2004 Dec 28;101(52):18105-10. doi: 10.1073/pnas.0406927102. Epub 2004 Dec 15.
PubMed 15601771
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose Escalation Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients Expressing Elevated eIF4E
- ClinicalTrials.gov ID
- NCT01309490
- Acronym / sponsor ID
- Ribavirin-004
- Conditions
- Malignant Solid Tumor
- Keywords
- high eIF4E expression, solid tumor cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual, competing studies
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 17 Mar 2011 (actual)
- Primary completion
- 29 Oct 2014 (actual)
- Study completion
- 29 Oct 2014 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether oral Ribavirin is safe and effective in treating patients with solid tumour cancers, that have high levels of the protein eIF4E.
Detailed description
This is a dose escalating, open-label, Phase I/II study of single agent oral ribavirin administered daily in solid tumour cancer patients who have failed standard treatments, overexpress eIF4E, and have easily accessible disease for serial biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribavirin, nucleoside analog | Experimental | Drug: Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Phase I part of study : Histologically or cytologically confirmed cancer at diagnosis, with advanced, incurable disease at the time of screening, who have progressed on or are not suitable for standard therapy.
- Phase II part of study: Histologically or cytologically confirmed BC or HNSCC at diagnosis, with advanced, incurable disease at the time of screening, who have progressed on or are not suitable for standard therapy.
- Willing to have a screening biopsy performed from an easily accessible lesion (ex. skin, superficial lymph node) AND whose tumour must overexpress eIF4E.
- Easily accessible lesion for serial biopsies (ex. skin, superficial lymph node, or other easily accessible site).
- At least 1 unidimensionally measurable lesion (based on the RECIST criteria) outside the CNS.
Key exclusion criteria (8 listed)
- Symptomatic brain metastases.
- Active cardiovascular disease as defined by New York Heart Association (NYHA) class III-IV categorization.
- Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up.
- Use of any investigational anti-cancer drug within 2 weeks before start of study treatment or inadequate recovery from any toxic effects of such therapy.
- Female patients who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibavirinDose Level: 1 1400 mg po BID Dose Level: 2 1800 mg po BID Dose Level: 3 2200 mg po BID Dose Level: 4 2600 mg po BID Dose Level: 5 3000 mg po BID | Drug | Ribavirin, nucleoside analog |
Primary outcome
Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D)
Time frame: Average 1.5 years
Phase II: Determine the overall response rate to therapy with ribavirin
Time frame: Average 1.5 years
7 secondary outcomes
Incidence and nature of DLTs
Time frame: 3 years
Incidence, nature and severity of adverse events
Time frame: 3 years
Time to and duration of response, defined as the first occurence of documented objective response until the time of recurrence or death from any cause
Time frame: 3 years
Clinical benefit rate, defined as the overall response rate and stable disease for greater than or equal to 24 weeks
Time frame: 3 years
Pharmacokinetic parameters of ribavirin determine by total exposure, maximum plasma concentration, etc.
Time frame: 3 years
Correlation between eIF4E activity and response
Time frame: 3 years
To determine the effect of ribavirin on the activity of eIF4E related pathways through correlative studies
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Low accrual, competing studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Background: PubMed 19433856Assouline S, Culjkovic B, Cocolakis E, Rousseau C, Beslu N, Amri A, Caplan S, Leber B, Roy DC, Miller WH Jr, Borden KL. Molecular targeting of the oncogene eIF4E in acute myeloid leukemia (AML): a proof-of-principle clinical trial with ribavirin. Blood. 2009 Jul 9;114(2):257-60. doi: 10.1182/blood-2009-02-205153. Epub 2009 May 11.
- Background: PubMed 15601771Kentsis A, Topisirovic I, Culjkovic B, Shao L, Borden KL. Ribavirin suppresses eIF4E-mediated oncogenic transformation by physical mimicry of the 7-methyl guanosine mRNA cap. Proc Natl Acad Sci U S A. 2004 Dec 28;101(52):18105-10. doi: 10.1073/pnas.0406927102. Epub 2004 Dec 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ribavirin in people with Malignant Solid Tumor, run by Jewish General Hospital at 1 site in Canada.
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 15 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 combined 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.
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 was stopped early (reason given: Low accrual, competing studies). Results are not available in the source record.
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?
Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D) (time frame: Average 1.5 years). The study lists 2 primary outcomes in all. 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 NCT01309490, 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 29 Jul 2025.