Study of M3814 in Combination With Capecitabine and Radiotherapy in Rectal Cancer
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2019 |
| Start Date: | March 4, 2019 |
| End Date: | August 22, 2025 |
| Contact: | US Medical Information |
| Email: | service@emdgroup.com |
| Phone: | 888-275-7376 |
A Multicenter Study With an Open-label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination With Capecitabine and Radiotherapy in Participants With Locally Advanced Rectal Cancer
The main purpose of the study is to define maximum tolerated dose (MTD), recommended Phase II
dose (RP2D) of M3814 in combination with capecitabine and radiotherapy (RT) in Phase Ib and
to evaluate the efficacy of M3814 in terms of Pathological Clinical Response (pCR)/Clinical
Complete Response (cCR) when administered in combination with capecitabine and RT versus
placebo, capecitabine, and RT in Phase II.
dose (RP2D) of M3814 in combination with capecitabine and radiotherapy (RT) in Phase Ib and
to evaluate the efficacy of M3814 in terms of Pathological Clinical Response (pCR)/Clinical
Complete Response (cCR) when administered in combination with capecitabine and RT versus
placebo, capecitabine, and RT in Phase II.
Inclusion Criteria:
- Participants who have an Eastern Cooperative Oncology Group Performance Status less
than or equals to (≤) 1
- Participants who have histologically confirmed and localized resectable rectal cancer
(Stage III)
- Participants who have lower edge of the tumors located at or below the peritoneal
reflection
- Participants who have evaluable (Phase Ib) or measurable (Phase II) disease according
to RECIST v1.1
- Adequate hematological, hepatic and renal function as defined in the protocol
- Male participants if they agree to the following during the intervention period and
for at least 12 weeks (a spermatogenesis cycle) after the last dose of study
intervention
- Female participants is eligible if she is not pregnant (that is after a confirmed
menstrual period and a negative serum pregnancy test), not breastfeeding
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Participants with history of any other significant medical disease or psychiatric
conditions that might in the assessment of the Investigator preclude safe
participation in the study
- Participants with history of difficulty swallowing, malabsorption, or other chronic
gastrointestinal disease or conditions that may hamper compliance and/or absorption of
the study intervention
- Unstable cardiovascular function within 6 months prior to enrollment
- Hypertension uncontrolled by medication
- Participants with history of other malignant disease within the past 5 years, other
than successfully treated basal carcinoma of the skin or carcinoma in situ of the
cervix
- Participants with known human immunodeficiency virus positivity, known active
hepatitis (for example, hepatitis B virus or hepatitis C virus), current alcohol
abuse, or cirrhosis
- Participants with ongoing active infection other than human immunodeficiency virus,
hepatitis B virus, or hepatitis C virus, or treatment with a live attenuated vaccine
within 4 weeks of dosing
- Participants with concomitant use of H2-blocker or proton pump inhibitors (PPIs) (or
unable to stop at least 5 days prior to the first treatment). Note that calcium
carbonate is acceptable
- Participation in any interventional clinical study within 28 days prior to Screening
or during participation in this study
- Other protocol defined exclusion criteria could apply.
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