Phase 2
Completed N=19
Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer
Source: ClinicalTrials.gov NCT03770689 ↗Enrolled (actual)
19
Serious AEs
36.8%
Results posted
Jul 2022
Primary outcomePrimary: Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC) — 0; 1; 1; 3 Participants
Summary
The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC) |
0; 1; 1; 3 | — |
| SECONDARY Number of Participants Wtih Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 5.0 |
1; 6; 6; 6; 1; 6 | — |
| SECONDARY Number of Participants With Abnormalities [Grade Greater Than or Equals to (>=) 3] in Laboratory Test Values |
1; 6; 6; 6 | — |
| SECONDARY Number of Participants With Markedly Abnormal Vital Sign Measurements |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Composite Pathological Complete Response (pCR)/ Clinical Complete Response (cCR) |
0.0; 16.7; 0.0; 0.0 | — |
| SECONDARY Disease-free Survival |
21.2 | — |
| SECONDARY Percentage of Participants With Pathological Complete Response (pCR) |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Clinical Complete Response (cCR) |
0.0; 16.7; 16.7; 16.7 | — |
| SECONDARY Time From Surgery to Local Recurrence |
NA | — |
| SECONDARY Time From Surgery to Distant Metastasis |
NA | — |
| SECONDARY Neoadjuvant Rectal (NAR) Score |
9.4; 13.8; 21.2 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Peposertib |
NA; 593; 728; 1350; NA; 653 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) (AUC0-t) of Peposertib |
NA; 2950; 4000; 7300; NA; 3450 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Peposertib |
NA; 1.00; 2.33; 2.43; NA; 2.05 | — |
| SECONDARY Total Body Clearance Following Oral Administration (CL/f) of Peposertib |
31.7; 34.5; 33.0 | — |
| SECONDARY Apparent Volume of Distribution (Vz/f) of Peposertib |
256; 274; 245; NA; 261; 217 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of Peposertib |
5.60; 5.51; 5.14; NA; 6.28; 5.04 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who have an Eastern Cooperative Oncology Group Performance Status less than or equals to ( = 150 millimeter of mercury (mmHg) and diastolic blood pressure >= 90 mmHg)
- 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 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.
Data sourced from ClinicalTrials.gov (NCT03770689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.