A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer

Phase 1

Terminated

• Conditions: Rectal Cancer
• Interventions: Drug: PEP503; Drug: 5-fluorouracil; Drug: capecitabine; Procedure: surgical resection; Radiation: Radiotherapy

• Registration Number: NCT02465593
• Lead Sponsor: PharmaEngine

Brief Summary

This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer).

There are 2 portions in this study.

* Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection.

* Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.

Detailed Description

The target population is composed by patients who have confirmed adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable, with tumor distal margin within 10 cm of the anal verge, with no evidence of distant metastatic disease, ECOG performance 0-1, and adequate bone marrow, renal and hepatic function.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Primary Completion: 2021-07-28
• Study Completion: 2021-07-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

• Prior history of pelvic radiation therapy
• Hypersensitivity to fluoropyrimidine
• Uncontrolled serious medical or psychiatric illness
• Myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months
• No more than 4 weeks since prior participation in any investigational drug study
• Major surgery within 28 days
• Other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
• Cardiovascular disease that would preclude study treatment or follow-up
• Informed consent not duly signed and dated to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEP503+5-FU/capecitabine+Radiotherapy	PEP503	Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
PEP503+5-FU/capecitabine+Radiotherapy	5-fluorouracil	Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
PEP503+5-FU/capecitabine+Radiotherapy	surgical resection	Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
PEP503+5-FU/capecitabine+Radiotherapy	Radiotherapy	Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
PEP503+5-FU/capecitabine+Radiotherapy	capecitabine	Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.

Primary Outcome Measures

Name	Time	Method
anti-tumor activity	up to 36 months	Anti-tumor activity as assessed by response rate (RR, as per RECIST 1.1) of PEP503 at the recommended volume given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
safety profile /the Dose Limiting Toxicity (DLT)	up to 36 months	Safety as assess the safety profile and determine the Dose Limiting Toxicity (DLT) of PEP503 given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
the recommended volume (dose)	up to 36 months	recommended volume (dose) of PEP503 examined by given as intratumor injection and activated by external beam radiation. with concurrent chemotherapy in patients with unresectable rectal cancer

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung City, Taiwan