A Study to Test MK-0646 (Dalotuzumab) Treatment in Combination with Irinotecan Compared to Cetuximab and Irinotecan Treatment in Patients with Metastatic Rectal Cancers
- Conditions
- Neoplasms
- Registration Number
- KCT0000497
- Lead Sponsor
- MSD Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 70
1.Patient has metastatic colorectal cancer whose primary tumor originated from the rectum.
2.Patient has archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies. Archival specimens must be tumor block, surgical specimens or core needle biopsy specimens. (Fine needle biopsies are not adequate.) Please refer to Procedures Manual for details on sample collection and processing.
3.Patient's tumor is KRAS wild type as determined by testing at the program central laboratory during the screening period as outlined in the dalotuzumab PN025 Assay Charter.
4. Patient's whose tumor over-expresses IGF-1, determined by the central laboratory during the screening. The IGF-1 level determination is outlined in the dalotuzumab PN025 Assay Charter.
5.Patient has at least one measurable lesion greater than or equal to 15 mm. (Refer to the Investigators’ Imaging Operations Manual [within the Procedures Manual] for detailed information].
6.Patient’s disease has progressed after treatment with both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy. Note: Failing oxaliplatin would include failure due to toxicities. Note: Failing irinotecan requires a minimum previous exposure to irinotecan of two cycles.
7.Patient is =18 years of age on the day of signing informed consent.
8.Patient has performance status 0-1 on the ECOG Performance Scale.
9.Patient has adequate organ function as indicated by the following laboratory values:
10.Female patient of childbearing potential has a negative serum or urine ß-hCG pregnancy test at baseline.
11.Patient, or patient’s legal representative, has voluntarily agreed to participate by giving written informed consent. For those institutions that do not allow a legal representative to provide consent on behalf of a patient, patients must be able to provide written informed consent for themselves. The patient may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
1.Patient has a mutant KRAS (mutKRAS) metastatic rectal cancer determined by testing at the program central laboratory during the screening period.
2.Patient has a high IGF-2 expressing metastatic rectal cancer determined by testing at the program central laboratory during the screening.
3.Patient is a known diabetic patient who is poorly controlled (HbA1c >8%).
4.Patient who has had chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery.
5.Patient who has had radiotherapy within two weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain.
6.Patient is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study.
7.Patient could not complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (>4 months exposure).
8.Patient has prior exposure to IGF-1R inhibitors or EGFR inhibitors (e.g. cetuximab, panitumumab).
9.Patient has known CNS metastases and/or carcinomatous meningitis.
10.Patient has primary central nervous system tumor.
11.Patient has a known hypersensitivity to the components of study drugs or its analogs that is not treatable by premedication with antihistamines and steroids.
12.Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
13.Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician.
14.Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
15.Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
16.Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
17.Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
18.Patient has known active Hepatitis B or C on antiviral treatment regimens.
19.Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
20.Patient is concurrently using growth hormone (GH), or growth hormone inhibitors.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progressin Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival