Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

Conditions

• Previously Treated Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SGI-110 Dose Escalation — DRUG
  * Dose level 1 (DL1): 45 mg/m\^2 administered as a subcutaneous injection * Dose level 1G (DL1G): 45 mg/m\^2 administered as a subcutaneous injection + growth factor support * Dose level -1 (DL-1): 30 mg/m\^2 administered as a subcutaneous injection * Dose level -1G (DL-1G): 30 mg/m\^2 administered as a subcutaneous injection + growth factor support
• Regorafenib — DRUG
  160 mg taken orally
• TAS-102 — DRUG
  35 mg/m\^2 taken orally
• SGI-110 — DRUG
  45 mg/m\^2 administered as a subcutaneous injection
• Irinotecan — DRUG
  125 mg/m\^2 administered IV

Study Details

This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).

Key Dates

Start date

Oct 23, 2013

Status verified

Aug 2020

Primary completion

Aug 26, 2019

Completion

Aug 26, 2019

Study Design

Enrollment

118 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1: Dose Escalation
  Subjects receive SGI-110 on days 1-5 and irinotecan on days 8 and 15 of each 28-day cycle. Various doses of SGI-110 are tested to determine the maximum tolerated dose in combination with irinotecan.
• Experimental: Phase 2: Arm A SGI-110 + irinotecan
  Subjects receive SGI-110 on days 1-5 and irinotecan on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) is given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement.
• Active Comparator: Phase 2: Arm B regorafenib or TAS-102
  Subjects received either regorafenib or TAS-102 based on physician and patient preference. Subjects that had received one of these standard of care drugs (regorafenib or TAS-102) prior to enrollment received the other on study. Regorafenib taken daily from days 1-21 of each 28-day cycle or TAS-102 taken twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects who had disease progression on Arm B were given the option to receive Arm A study drugs after a 14 day wash-out period.

Primary Outcome Measure

Number of Participants Experiencing a Dose Limiting Toxicity [ Time Frame: 28 days ]

Locations (3)

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