Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03635021 | Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 419 | — | — | Oct 15, 2018 | Jun 28, 2025 | Oct 21, 2024 | 1 | Spain |
| NCT00115765 | PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study | PHASE3 | COMPLETED | 1,053 | — | — | Jun 1, 2005 | May 1, 2009 | Oct 17, 2018 | - | — |
| NCT00113763 | Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer | PHASE3 | COMPLETED | 463 | — | — | Jan 1, 2004 | Jun 1, 2009 | Nov 7, 2022 | - | — |
| NCT00940316 | Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer | PHASE2 | COMPLETED | 28 | — | — | Jan 18, 2010 | Jan 1, 2015 | May 7, 2019 | 10 | United States |
| NCT00842257 | Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer | PHASE2 | COMPLETED | 20 | — | — | May 1, 2009 | Dec 1, 2011 | May 16, 2017 | 3 | United States |
| NCT00089635 | Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer | PHASE2 | COMPLETED | 203 | — | — | Aug 1, 2004 | Aug 1, 2008 | Nov 7, 2022 | - | — |
| NCT00083616 | Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy | PHASE2 | COMPLETED | 185 | — | — | Mar 1, 2004 | Dec 1, 2008 | Jan 10, 2014 | - | — |
| NCT00425204 | Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment | PHASE2 | COMPLETED | 31 | — | — | Mar 1, 2004 | Mar 1, 2008 | Sep 15, 2008 | - | — |
| NCT00111761 | Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer | PHASE2 | COMPLETED | 43 | — | — | Jul 1, 2002 | Oct 1, 2008 | Dec 12, 2013 | - | — |
35-month PFSR defined as the number of patients, who at 35 months after randomization, have not had second or first disease progression nor died (due to any cause), over the total number of evaluable patients.
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum
Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
The response rate of single agent panitumumab among patients with KRAS wild-type (Kirsten rat sarcoma viral oncogene homolog) colorectal cancer previously treated with cetuximab. Inclusive of three patients with clinical progression prior to first re-staging CT scans. Response rate evaluated using RECIST (Response Evaluation Criteria In Solid Tumors). Best overall response is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). RECIST: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions
Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.
Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.
Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).
The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | FOLFOX regimen panitumumab FOLFIRI regimen bevacizumab |
| Sequence 2 | EXPERIMENTAL | FOLFOX regimen bevacizumab FOLFIRI regimen panitumumab |
| Oxaliplatin and bevacizumab without panitumumab | ACTIVE_COMPARATOR | Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone. |
| Irinotecan and bevacizumab plus panitumumab | EXPERIMENTAL | Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W |
| Irinotecan and bevacizumab without panitumumab | ACTIVE_COMPARATOR | Irinotecan-based chemotherapy and Bevacizumab Q2W alone |
| Oxaliplatin and bevacizumab plus panitumumab | EXPERIMENTAL | Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W |
| Panitumumab plus best supportive care | EXPERIMENTAL | Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines. |
| Best Supportive Care | OTHER | Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy. |
| Arm A: Erlotinib + Panitumumab + Irinotecan | EXPERIMENTAL | Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm B: Erlotinib + Panitumumab | EXPERIMENTAL | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. |
| Arm C: Erlotinib + Panitumumab | EXPERIMENTAL | Patients receive erlotinib hydrochloride and panitumumab as in arm B. |
| Panitumumab | EXPERIMENTAL | Panitumumab administered by a central line infusion on days 1 and 15 of each 4 week cycle. |
| Open Label | EXPERIMENTAL | Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks. |
| Part 1: Panitumumab + IFL | EXPERIMENTAL | Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen) |
| Part 2: Panitumumab + FOLFIRI | EXPERIMENTAL | Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen) |
| Name | Type | Description |
|---|---|---|
| FOLFOX regimen | DRUG | oxaliplatin 85 mg/m2 administered by IV infusion over 120 minutes on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46- 48 hours on Days 1 and 2 |
| Panitumumab | DRUG | 6 mg/kg administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 14-day cycle |
| Bevacizumab | DRUG | 5 mg/kg administered by IV infusion over 60 minutes on Day 1 of each 14-day cycle |
| FOLFIRI regimen | DRUG | irinotecan 180 mg/m2 administered as a 90 minutes IV infusion on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46-48 hours on Days 1 and 2 |
| Oxaliplatin Based Chemotherapy | DRUG | Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. |
| Irinotecan Based Chemotherapy | DRUG | Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. |
| Best supportive care | OTHER | Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases). |
| erlotinib hydrochloride | DRUG | Given orally 150mg daily |
| irinotecan hydrochloride | DRUG | Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype |
| Panitumumab (ABX-EGF) | DRUG | Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks. |
| Irinotecan | DRUG | Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate. |
| 5-Fluorouracil | DRUG | Part 1: IV bolus 500 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m\^2 and infusional 2400-3000 mg/m\^2 over 46 hours once every other week until disease progression or unable to tolerate. |
| Leucovorin | DRUG | Part 1: IV bolus 20 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m\^2 every other week until disease progression or unable to tolerate. |
Inclusion Criteria: 1. Man or woman at least 18 years old. 2. Capable of understand, sign and date an informed consent approved by an IEC. 3. Histologically confirmed adenocarcinoma of the left colon or rectum (originate in the splenic flexure, descending colon, sigmoid colon, or rectum) in patient...