Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00545545
Other study ID # BT-CL-PGG-CRC0713
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 16, 2007
Last updated March 30, 2010
Start date October 2007
Est. completion date December 2009

Study information

Verified date March 2010
Source Biothera
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Interventional

Clinical Trial Summary

Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Is between the ages of 18 and 75 years old, inclusive;

2. Has a recurrent or progressive carcinoma of the colon or rectum with documented histological confirmation of primary carcinoma;

3. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;

4. Has previously received treatment with 5-FU, alone or in combination with other anti-tumor medications (except as in exclusion #1 below); Prior treatment with capecitabine (Xeloda®) will be considered to fulfill the requirement for prior treatment with 5-FU;

5. Has a Karnofsky Score of = 70;

6. Has a life expectancy of > 3 months;

7. Has adequate bone marrow reserve as evidenced by:

1. ANC = 1,500/µL

2. PLT = 100,000/µL

3. HGB = 9 g/dl;

8. Has adequate renal function as evidenced by serum creatinine = 1.5X the upper limit of normal (ULN) for the reference lab;

9. Has adequate hepatic function as evidenced by:

1. Serum total bilirubin = 1.0 mg/dL

2. AST = 3X ULN for the reference lab (= 5X ULN for patients with known hepatic metastases)

3. ALT = 3X ULN for the reference lab (= 5X ULN for patients with known hepatic metastases);

10. Has discontinued any CYP3A4 enzyme-inducing anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) and antimicrobials (such as refampin and rifabutin), St. John's Wort, and ketoconasole at least two weeks prior to Day 1

11. Has recovered from the effects of any prior surgery, radiotherapy, or chemotherapy;

12. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC); and

13. If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception during the study and for 120 days following the last dose of study medication (an effective form of contraception is an hormonal contraceptive or a double-barrier method).

Exclusion Criteria:

1. Has previously received treatment with cetuximab or irinotecan;

2. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;

3. Has a hereditary fructose intolerance;

4. Has a known hypersensitivity to baker's yeast, or has an active yeast infection;

5. Has had previous exposure to Betafectin® or Imprime PGG;

6. Has received previous radiation therapy to >30% of active bone marrow;

7. Has a fever of >38.5º C within 3 days prior to initial dosing;

8. Has known or suspected central nervous system (CNS) metastases;

9. Had a second malignancy within the previous 5 years, except for basal cell carcinoma, cervical intra-epithelial neoplasia or curatively-treated prostate cancer with a PSA of < 2.0 ng/mL;

10. Has known HIV/AIDS, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the investigator's opinion would prevent participation;

11. If female, is pregnant or breast-feeding;

12. Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication); or

13. Has previously received an organ or progenitor/stem cell transplant.

Study Design

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


Intervention

Biological:
Safety and efficacy of escalating doses
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle) and irinotecan on Day 1 of each week for 4 weeks with a 2-week rest. Number of Cycles: until progression or unacceptable toxicity develops.
Safety and efficacy of escalating doses.
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.

Locations

Country Name City State
Philippines Medical City Makati City
Philippines Philippine General Hospital Manila

Sponsors (1)

Lead Sponsor Collaborator
Biothera

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine safety and maximum tolerated dosage of Imprime PGGwhen used in combination with cetuximab with and without irinotecan therapy in patients with recurrent/progressive colorectal carcinoma previously treated with a 5-FU regimen. Prospective No
Secondary To determine the pharmacokinetic (PK) profile of Imprime PGG administered in combination with cetuximab with concomitant irinotecan therapy in patients with colorectal cancer. Prospective No
Secondary To determine the tumor response rates (complete response, partial response, stable disease, overall response rate), time to progression, duration of overall tumor response, and the duration of stable disease in patients receiving the combination therapy. Prospective No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05518032 - Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC) Phase 2
Active, not recruiting NCT02738606 - Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery Phase 2
Recruiting NCT01365169 - Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients" N/A
Completed NCT01522820 - Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors Phase 1
Recruiting NCT04017650 - Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT01638533 - Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Phase 1
Recruiting NCT06307548 - Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT02873195 - Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2
Completed NCT03095781 - Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer Phase 1
Not yet recruiting NCT05883683 - Molecular Study and Precision Medicine for Colorectal Cancer
Completed NCT02973672 - Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas Phase 1/Phase 2
Terminated NCT02650635 - TLR8 Agonist VTX-2337 and Cyclophosphamide in Treating Patients With Metastatic, Persistent, Recurrent, or Progressive Solid Tumors Phase 1
Terminated NCT02508077 - FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer Phase 2
Not yet recruiting NCT03823079 - Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia Phase 2
Active, not recruiting NCT04616183 - LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT02713373 - Cetuximab and Pembrolizumab in Treating Patients With Colorectal Cancer That is Metastatic or Cannot Be Removed by Surgery Phase 1/Phase 2
Active, not recruiting NCT02188264 - Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT02465060 - Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Phase 2
Completed NCT03087591 - APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery Phase 1
Completed NCT03403634 - Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver Phase 2