Test
ROSETTA CRC 203 Eligibility criteria
Sample Requirement
Study Assessments
Study Vendors
100

This is the largest planet in our solar system.

Jupiter

100

Participants must have this type of colorectal cancer, confirmed by histology, that is not amenable to curative surgery.

Recurrent or metastatic colorectal adenocarcinoma

100

If FFPE blocks cannot be provided, a minimum of this many unstained slides must be submitted, and they must be freshly cut within 4 months.

15 unstained slides

100

Hematology, chemistry, and urinalysis laboratory assessments are expected to be performed locally within these many hours prior to each dose.

72 hours

100

For these studies, sites must request these items themselves, so checking inventory early helps prevent delays.

Central lab study kits

200

This playwriter wrote “Romeo and Juliet"

William Shakespeare

200

For Phase 2, these two locally tested RAS gene mutation statuses must be documented prior to randomization.

KRAS and NRAS

200

If a fresh tumor biopsy poses significant risk to the participant, this type of tissue sample may be submitted instead if the patient has not received any anti-cancer therapy since sampling.

Archived tumor tissue

200

A surveillance brain MRI is expected to be performed this often while on-treatment and in follow-up if the participant has a known history of brain metastasis.

Every 12 weeks

200

This certificate should be completed for at least one site personnel and submitted to the imaging vendor prior to screening first study participant? 

Clario Training Certificate

300

Tokyo is the capital of this country.

Japan

300

To be eligible, participants with previously treated CNS metastases must be neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least this many weeks prior to randomization.

2 weeks

300

These samples are collected at these different timepoints on the same visit day? 

Pre-dose and End of Infusion PK samples

300

Pregnancy testing for individuals of child-bearing potential is performed this often for participants on a Q2W schedule.

Every 4 weeks OR every other cycle

300

This vendor will be used to manage PRO assessments in phase 3 portion of the studies? 

Clario

400

Plants make their own food using sunlight in this process.

Photosynthesis

400

A prior malignancy active within this timeframe of enrollment, except for certain low-risk cancers, will exclude a participant from the study.

2 years

400

For these studies, only these two blood sample types are sent in ambient condition on the day of collection.

Immunophenotyping and ctDNA samples

400

Even if dosing is delayed, these assessments should continue as per protocol.

Tumor assessments

400

These transactions within Endpoint (IRT system) can only be performed by Unblinded site pharmacists or drug preparer

Study treatment visit transactions

500

Egypt is located on this continent.

Africa

500

Known deficiency in this enzyme, which must be systematically screened for where locally mandated, is an exclusion criterion.

DPD (dihydropyrimidine dehydrogenase)

500

This scan schedule applies during treatment until Week 54 starting C1D1 in both studies

Imaging frequency of every 6 weeks (±7 days)

500

These are the two timepoints for safety follow up visits after the last dose? 

Day 30 and Day 90

500

Participants can use this app to track payments related travel, meal reimbursements and stipends 

Mural Health

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