Clinical trial · Interventional
A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI
A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI in Patients With Ras Mutant Positive Metastatic Colorectal Cancer, Either Newly Diagnosed or Previously Treated.
NCT01322815CI-TRIAL-00023492terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual rate
Summary
Brief summary (as posted)
The purpose of this study is to test the safety of GI-4000 and see what effects (good and bad) it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to a standard of care which is a standard therapy given to patients with your type of cancer (colon).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy and GI-4000 | Drug | — | UNRESOLVED |
| GI-4000 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy and GI-4000
- description
- Standard chemotherapy and bevacizumab 40 yeast units (YU) GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles. maintenance of GI-4000 injection and bevacizumab every 2 weeks
- interventionNames
- Drug: chemotherapy and GI-4000
- type
- EXPERIMENTAL
- label
- GI-4000 and bevacizumab
- description
- maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
- interventionNames
- Drug: GI-4000
Primary outcomes (1)
- measure
- Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic colorectal cancer with a Ras mutation * Measurable or evaluable disease * No prior therapy fore metastatic disease except for group A: \> 6 months since completion of adjuvant therapy and Group B: those patients who enroll just after completing bevacizumab plus FOLFOX or FOLFIRI * Anticipated survival of at least 6 months * Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Ability to maintain weight * Normal organ and marrow function * Women of child-bearing potential and men must agree to avoid pregnancy or fathering a child for the duration of study participation and for 6 months after the final scheduled study visit. * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Prior chemotherapy other than that listed in inclusion criteria * Receiving any other investigational agent * Known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis * History of known hypersensitivity to S. cerevisiae, bevacizumab or any component of FOLFOX or FOLFIRI * Concurrent and chronic therapy with corticosteroids or any other immunosuppressive drugs * Uncontrolled hypertension, unstable angina, congestive heart failure, peripheral vascular disease, serious cardiac arrythmias requiring medication * History of heart attack or stroke within 6 months before enrollment * History of intra-abdominal abscess, abdominal fistula, gastrointestinal perforation, or active peptic ulcer disease * Bleeding disorder or coagulopathy * Serious non-healing wound, ulcer or bone fracture * Major surgical procedure, open biopsy, or traumatic injury within 4 weeks prior to enrollment or anticipation of need for surgery during the study * Known active infection with HIV, hepatitis B or C * History of splenectomy * History of Crohn's disease or ulcerative colitis * History of organ transplantation * Evidence of immunodeficiency or immune suppression * Any Autoimmune disease * Active infection * Concurrent malignancy * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.