Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer

Conditions

• Locally Advanced Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Peposertib 50 mg — DRUG
  Participants received peposertib 50 milligram (mg) once daily 5 days per week up to 5.5 weeks.
• Peposertib 100 mg — DRUG
  Participants received peposertib 100 mg once daily 5 days per week up to 5.5 weeks.
• Peposertib 150 mg — DRUG
  Participants received peposertib 150 mg once daily 5 days per week up to 5.5 weeks.
• Peposertib 250 mg — DRUG
  Participants received peposertib 250 mg once daily 5 days per week up to 5.5 weeks.
• Capecitabine — DRUG
  Participants received capecitabine at a dose of 825 milligram per square meter (mg/m\^2) twice daily 5 days per week up to 5.5 weeks.
• Radiotherapy (RT) — RADIATION
  Participants received RT 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks.

Study Details

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).

Key Dates

Start date

Mar 20, 2019

Status verified

Mar 2023

Primary completion

Jun 21, 2021

Completion

Feb 21, 2022

Study Design

Enrollment

19 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Peposertib 50 mg + RT + Capecitabine
  Participants received peposertib 50 milligram (mg) once daily in combination with capecitabine 825 milligram per square meter (mg/m\^2) twice daily 5 days per week and radiotherapy (RT) of 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.
• Experimental: Peposertib 100 mg + RT + Capecitabine
  Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m\^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.
• Experimental: Peposertib 150 mg + RT + Capecitabine
  Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m\^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.
• Experimental: Peposertib 250 mg + RT + Capecitabine
  Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m\^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.

Primary Outcome Measure

Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC) [ Time Frame: Time from first study intervention up to 19 weeks (including 5.5 weeks of treatment and 13.5 weeks of short term safety follow-up period) ]

Locations (10)

Find similar trials in Aurora, CO

Related Studies

• SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer
  PHASE1 · Recruiting · University of Miami · Miami, Florida