A Phase 1b/2, Dose-escalation, Randomized, Multicenter Study of Maintenance Ivaltinostat plus Capecitabine or Capecitabine Monotherapy in Patients with Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on First Line FOLFIRINOX Chemotherapy

Cancer Categories

Gastrointestinal (GI)

Karmanos Trial ID

2022-049

NCT ID

NCT05249101

Age Group

Adult

Scope

National

Phase

Phase I/II

Principal Investigator

Anthony
Shields, M.D., Ph.D.
Oncology - Medical View Profile

Objective:

Primary Objectives:

Phase 1b

To determine the safety, tolerability, and RP2D of ivaltinostat in combination with capecitabine

Phase 2

To determine the efficacy, as measured by Investigator-adjudicated PFS, of ivaltinostat in combination with capecitabine and capecitabine monotherapy for PDAC maintenance treatment after disease response or stability with FOLFIRINOX chemotherapy regimen

Secondary Objectives:

Phase 1b

To determine the pharmacokinetic (PK) profile of ivaltinostat and capecitabine administered in combination
Efficacy of ivaltinostat in combination with capecitabineEfficacy of ivaltinostat in combination with capecitabine

Phase 2

Efficacy of ivaltinostat in combination with capecitabine and capecitabine monotherapy
To further assess the safety and tolerability of ivaltinostat in combination with capecitabine and capecitabine monotherapy
To further evaluate the PK profile of ivaltinostat and capecitabine in combination

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Eligibility

Inclusion Criteria:

Age: ≥18 years
For Phase 1b, histologically or cytologically confirmed pancreatic adenocarcinoma (locally advanced or metastatic) with at least 1 prior therapy in either the advanced or perioperative setting
For Phase 1b, measurable disease and/or non-measurable disease per RECIST v1.1
For Phase 2, histologically or cytologically confirmed pancreatic adenocarcinoma without evidence of disease progression while receiving initial chemotherapy for metastatic disease (e.g., must have had a demonstrated CR, PR, or SD following initial chemotherapy).
For Phase 2, measurable disease and/or non-measurable or no evidence of disease assessed by baseline CT (or MRI where CT is contraindicated). RECIST v1.1 will be used to allow for assessment of disease progression due to new lesions in patients with no evidence of disease at baseline. Patients with no evidence of disease following FOLFIRINOX chemotherapy will be deemed to have radiographic disease progression if new lesions are detected.
For Phase 2, treatment with FOLFIRINOX for metastatic pancreatic adenocarcinoma at full or modified doses, for a minimum of 16 weeks, and no evidence of progression based on the radiographic imaging.
a. Randomization must occur within 6 weeks of the last dose of chemotherapy.
b. Patients who have received at least 16 weeks of FOLFIRINOX combination regimen but had non-fluoropyrimidine chemotherapeutic agents discontinued prior to 16 weeks due to toxicity are eligible if they have no radiographic evidence of disease.
For Phase 2, patients who received prior chemotherapy or prior chemoradiation for a prior cancer or as adjuvant/neoadjuvant treatment for pancreatic adenocarcinoma are eligible provided at least 12 months have elapsed between the last dose of treatment and initiation of the FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma.
Prior radiation therapy is allowed, provided >14 days have elapsed since completion of radiation prior to randomization.
Adequate organ function
ECOG Performance Status 0-1 at the date of signing the informed consent.

Exclusion Criteria:

For Phase 2, radiographic progression of tumor per RECIST 1.1 between start of first line FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma and randomization.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days before Cycle 1 Day 1. The patient can receive a stable dose of bisphosphonates or RANKL directed therapy for bone metastases before and during the study as long as these were initiated at least 2 weeks prior to study treatment
For Phase 2, not receiving FOLFIRINOX as initial therapy for metastatic PDAC. Patients who received FOLFIRINOX initially and who needed to discontinue irinotecan or oxaliplatin due to toxicity are eligible, provided they received at least 4 weeks (2 cycles) of FOLFIRINOX
For Phase 2, more than 1 prior line of therapy for metastatic PDAC
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices