Clinical trialPhase 1Completed
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer
FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 2 Preceded by Dose Finding in Phase 1
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 30 November 2017
- Expected end
- 31 January 2019
- Enrollment
- 12 participants
- Sites
- 7
- Primary outcomes
- Number of Participants With Treatment-related Adverse Events ≥ Grade 2; Number of Participants With Dose Limiting Toxicities (DLTs)
- Sponsor
- Industry
- Results posted
- 2023-01-27
- Last update
- 28 February 2024
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
The primary objective of the phase 1 portion of this study is to determine the recommended dose of bemarituzumab in combination with 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) to use in the phase 2 portion of the trial.
Detailed description public domain (ClinicalTrials.gov)
Phase 1 is an open-label dose-escalation of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6). Eligible patients will have unresectable locally advanced or metastatic GI cancer of any type and be candidates to receive at least 2 doses of mFOLFOX6 chemotherapy. Phase 1 consists of 2 dosing cohorts of bemarituzumab in combination with mFOLFOX6 to determine the recommended dose of bemarituzumab in combination with mFOLFOX6 for the phase 2 portion of the study (see study record NCT03694522).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Treatment-related Adverse Events ≥ Grade 2 [From first dose of study drug up to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in the bemarituzumab 6 mg/kg group and 19.4 (4.0, 35.4) weeks in the bemarituzumab 15 mg/kg group.]. Count Of Participants, Participants. Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 1; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 4.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Dose Limiting Toxicities (DLTs) [28 days]. Count Of Participants, Participants. Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=8): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Treatment-emergent Adverse Events [From first dose of study drug up to 28 days after last dose; Actual median (min, max) duration of the treatment emergent period was 19.3 (12.3, 22.3) weeks in the bemarituzumab 6 mg/kg group and 19.4 (4.0, 35.4) weeks in the bemarituzumab 15 mg/kg group.]. Count Of Participants, Participants. Any treatment-emergent adverse event (TEAE): Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 3; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 9. TEAE with Grade ≥ 3: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 1; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 6. TEAE related to any study drug: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 3; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 9. TEAE related to bemarituzumab: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 2; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 5. TEAE related to any agent of mFOLFOX6: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 3; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 9. TEAE with Grade ≥ 3 related to any study drug: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 1; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 4. Serious adverse event (SAE): Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 4. SAE related to any study drug: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 1. SAE related to bemarituzumab: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 0. SAE related to any agent of mFOLFOX6: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 1. TEAE of special interest: corneal/retina: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 4. TEAE of special interest: corneal/retina related to bemarituzumab: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 4. TEAE of special interest: corneal/retina leading to discontinuation of bemarituzumab: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 2. TEAE leading to discontinuation of bemarituzumab: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 4. TEAE leading to discontinuation of any agent of mFOLFOX6: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 4. TEAE leading to dose reduction of bemarituzumab: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 1; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 0. TEAE leading to dose reduction of any agent of mFOLFOX6: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 1; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 5. TEAE leading to death (Grade 5): Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab [Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours end of infusion; Cycle 2 day 1 at predose, 0.25 and 48 hours after end of infusion.]. Mean, µg/mL (Standard Deviation). Cycle 1: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 119 (8.52); Bemarituzumab 15 mg/kg + mFOLFOX6 (n=8): 329 (60.3). Cycle 2: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 123 (13.8); Bemarituzumab 15 mg/kg + mFOLFOX6 (n=8): 377 (82.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Observed Serum Concentration of Bemarituzumab at the End of the Dose Interval (Ctrough) [Cycle 1 day 14 predose for cohort 1 and day 8 predose for cohort 2; Cycle 2 day 14 predose]. Mean, µg/mL (Standard Deviation). Cycle 1: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 16.5 (8.80); Bemarituzumab 15 mg/kg + mFOLFOX6 (n=8): 118 (25.1). Cycle 2: Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 25.6 (10.6); Bemarituzumab 15 mg/kg + mFOLFOX6 (n=8): 131 (55.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Area Under the Observed Concentration-time Curve From the Time of Dosing to Day 14 (AUC0-14) [Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours after the end of infusion.]. Mean, μg*day/mL (Standard Deviation). Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 556 (232); Bemarituzumab 15 mg/kg + mFOLFOX6 (n=7): 2350 (394).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Terminal Half-life (t1/2) of Bemarituzumab [Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours after end of infusion.]. Mean, days (Standard Deviation). Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 8.35 (3.36); Bemarituzumab 15 mg/kg + mFOLFOX6 (n=3): 4.23 (0.447).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Treatment Induced Anti-bemarituzumab Antibodies [Samples were collected for ADA analysis predose on day 1 of Cycles 1, 2, 3, 7, and 10 and at 28 days following the last dose.]. Count Of Participants, Participants. Bemarituzumab 6 mg/kg + mFOLFOX6 (n=3): 0; Bemarituzumab 15 mg/kg + mFOLFOX6 (n=9): 0.