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An Open-label, Dose Escalation Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients Expressing Elevated eIF4E


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Solid Tumour

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Trial Information

An Open-label, Dose Escalation Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients Expressing Elevated eIF4E


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.


Inclusion Criteria:



1. 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.

2. Willing to have a screening biopsy performed from an easily accessible lesion (ex.
skin, superficial lymph node) AND whose tumour must overexpress eIF4E.

3. Easily accessible lesion for serial biopsies (ex. skin, superficial lymph node, or
other easily accessible site).

4. At least 1 unidimensionally measurable lesion (based on the RECIST criteria) outside
the CNS.

5. ECOG 0, 1, or 2.

6. Adequate recovery (excluding alopecia) from previous surgery, radiation, and
chemotherapy.

7. Adequate wash-out period from last therapy (at least 3 weeks).

8. Life expectancy ≥ 12 weeks.

9. Age ≥ 18 years old.

10. 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.

11. 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.

12. Adequate hematopoietic function: neutrophils ≥ 1.0 x 109/L, platelets ≥ 75 x 109/L.

13. Provide written consent after the investigational nature, study design, risks and
benefits of the study have been explained.

14. Accessible for treatment and follow up.

Exclusion Criteria:

1. Symptomatic brain metastases.

2. Active cardiovascular disease as defined by New York Heart Association (NYHA) class
III-IV categorization.

3. Intercurrent illness or medical condition precluding safe administration of the
planned protocol treatment or required follow-up.

4. 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.

5. Female patients who are pregnant or breastfeeding.

6. 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).

7. Known infection with HIV.

8. 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D)

Outcome Time Frame:

Average 1.5 years

Safety Issue:

Yes

Authority:

Canada: Health Canada

Study ID:

Ribavirin-004

NCT ID:

NCT01309490

Start Date:

March 2011

Completion Date:

June 2014

Related Keywords:

  • Malignant Solid Tumour
  • high eIF4E expression
  • solid tumor cancer
  • Neoplasms

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