Clinical trialPhase 1 / Phase 2Completed
A Study for Participants With Pancreatic Cancer
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- February 2009
- Expected end
- December 2013
- Enrollment
- 157 participants
- Sites
- 30
- Primary outcomes
- Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine; Phase 2: Overall Survival (OS)
- Sponsor
- Industry
- Results posted
- 2018-04-17
- Last update
- 17 April 2018
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Brief summary public domain (ClinicalTrials.gov)
The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that can be safely administered 24 hours after gemcitabine treatment. This dose was then used for the Phase 2 portion of the study. The Phase 2 portion of the study evaluated whether LY2603618, when administered 24 hours after gemcitabine therapy, was an effective treatment for participants with pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
Phase 1 included a dose escalation of LY2603618 doses from 70 milligrams/meter squared (mg/m\^2) to 250 mg/m\^2 divided into 5 cohorts. Each participant was assigned to a single cohort with no intra-participant dose escalation. Phase 1 also included an expansion cohort where participants received a flat dose of 200 or 230 mg LY2603618. Participants received gemcitabine on Days 1, 8, and 15, followed by LY2603618 on Days 2, 9, and 16 of each 28-day cycle. The purpose of the Phase 1 portion was to determine the maximum tolerated LY2603618 dose to be carried into the Phase 2 portion of the study.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine [Baseline through 18 months]. Number, milligrams (mg). Phase 1: LY2603618 + Gemcitabine (n=50): 230.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase 2: Overall Survival (OS) [Phase 2: Baseline to date of death]. Median, months (95% Confidence Interval). Phase 2: LY2603618 + Gemcitabine (n=65): 7.8 (5.0 to 11.1); Phase 2: Gemcitabine (n=34): 8.3 (5.1 to 14.1). Analysis, Phase 2: LY2603618 + Gemcitabine vs Phase 2: Gemcitabine: Bayesian Posterior Probability 0.333; superiority or other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618 [Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.]. Geometric Mean, nanograms per milliliter (ng/mL) (Geometric Coefficient of Variation). 70 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 3530 (23). 70 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 3360 (26). 70 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 3100 (12). 105 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 4890 (25). 105 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 5170 (38). 105 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 5360 (23). 150 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 4280 (29). 150 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 5040 (38). 150 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 4370 (38). 200 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 4870 (63). 200 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 5360 (40). 200 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 5290 (40). 250 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 7990 (25). 250 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 7990 (6). 250 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 5290 (35). 200 mg (flat dose), Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 3440 (65). 200 mg (flat dose), Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 3470 (61). 200 mg (flat dose), Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 3640 (45). 230 mg (flat dose), Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 4820 (72). 230 mg (flat dose), Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 4980 (35). 230 mg (flat dose), Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 3830 (26).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618 [Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.]. Geometric Mean, ng/mL (Geometric Coefficient of Variation). Cycle 1 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 3170 (50). Cycle 1 /Day 16: Phase 2: LY2603618 + Gemcitabine (n=62): 3410 (50). Cycle 2 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 2390 (54).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618 [Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.]. Geometric Mean, nanogram*hour/milliliter (ng*h/mL) (Geometric Coefficient of Variation). AUC(0-24), 70 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 21300 (24). AUC(0-24), 70 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 21200 (27). AUC(0-24), 70 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 19900 (24). AUC(0-24), 105 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 40500 (23). AUC(0-24), 105 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 50100 (32). AUC(0-24), 105 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 49800 (4). AUC(0-24), 150 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 32200 (27). AUC(0-24), 150 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 40000 (29). AUC(0-24), 150 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 31000 (42). AUC(0-24), 200 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 40200 (42). AUC(0-24), 200 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 39800 (36). AUC(0-24), 200 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 44300 (39). AUC(0-24), 250 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 88800 (27). AUC(0-24), 250 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 61000 (63). AUC(0-24), 250 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 40000 (112). AUC(0-24), 200 mg (flat), Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 22900 (77). AUC(0-24), 200 mg (flat), Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 28700 (63). AUC(0-24), 200 mg (flat), Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 23800 (62). AUC(0-24), 230 mg (flat), Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 32400 (38). AUC(0-24), 230 mg (flat), Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 32300 (22). AUC(0-24), 230 mg (flat), Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 32500 (24). AUC(0-tlast), 70 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 24600 (28). AUC(0-tlast), 70 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 27500 (21). AUC(0-tlast), 70 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 25800 (29). AUC(0-tlast), 105 mg/m^2, Cycle 1 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 65800 (53). AUC(0-tlast), 105 mg/m^2, Cycle 1 /Day 16: Phase 1: LY2603618 + Gemcitabine (n=50): 75500 (46). AUC(0-tlast), 105 mg/m^2, Cycle 2 /Day 2: Phase 1: LY2603618 + Gemcitabine (n=50): 79600 (19). AUC(0-tlast), 150 mg/m^2, Cycle 1 /Day 2:
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618 [Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.]. Geometric Mean, ng*h/mL (Geometric Coefficient of Variation). AUC(0-24), Cycle 1 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 23200 (68). AUC(0-24), Cycle 1 /Day 16: Phase 2: LY2603618 + Gemcitabine (n=62): 23700 (60). AUC(0-24), Cycle 2 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 19800 (63). AUC(0-tlast), Cycle 1 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 22200 (73). AUC(0-tlast), Cycle 1 /Day 16: Phase 2: LY2603618 + Gemcitabine (n=62): 20800 (78). AUC(0-tlast), Cycle 2 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 20100 (64). AUC(0-inf), Cycle 1 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 29400 (84). AUC(0-inf), Cycle 1 /Day 16: Phase 2: LY2603618 + Gemcitabine (n=62): 29100 (74). AUC(0-inf), Cycle 2 /Day 2: Phase 2: LY2603618 + Gemcitabine (n=62): 23300 (69).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 2: Progression-free Survival (PFS) [Phase 2: Baseline to measured progressive disease or date of death from any cause]. Median, months (95% Confidence Interval). Phase 2: LY2603618 + Gemcitabine (n=65): 3.5 (2.1 to 3.6); Phase 2: Gemcitabine (n=34): 5.6 (2.6 to 7.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 2: Overall Response Rate [Phase 2: Baseline to measured progressive disease or date of death from any cause]. Number, percentage of participants (95% Confidence Interval). Phase 2: LY2603618 + Gemcitabine (n=65): 21.5 (12.3 to 33.5); Phase 2: Gemcitabine (n=34): 8.8 (1.9 to 23.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 2: Clinical Benefit Rate [Phase 2: Baseline to measured progressive disease or date of death from any cause]. Number, percentage of participants (95% Confidence Interval). Phase 2: LY2603618 + Gemcitabine (n=65): 55.4 (42.5 to 67.7); Phase 2: Gemcitabine (n=34): 64.7 (46.5 to 80.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 2: Duration of Response [Phase 2. Baseline to measured progressive disease or date of death from any cause]. Median, months (95% Confidence Interval). Phase 2: LY2603618 + Gemcitabine (n=14): 3.5 (1.9 to 5.8); Phase 2: Gemcitabine (n=3): 6.0 (3.7 to 6.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 1: Electrocardiogram QTc Prolongation [Phase 1: Days 2 and 16 of Cycle 1]. Count Of Participants, Participants. 70 mg/m^2, <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 2. 70 mg/m^2, >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 1. 70 mg/m^2, >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 105 mg/m^2, <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 2. 105 mg/m^2, >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 105 mg/m^2, >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 150 mg/m^2, <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 6. 150 mg/m^2, >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 1. 150 mg/m^2, >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 200 mg/m^2, <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 11. 200 mg/m^2, >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 200 mg/m^2, >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 250 mg/m^2, <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 6. 250 mg/m^2, >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 250 mg/m^2, >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 200 mg (flat dose), <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 9. 200 mg (flat dose), >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 1. 200 mg (flat dose), >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. 230 mg (flat dose), <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 8. 230 mg (flat dose), >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 2. 230 mg (flat dose), >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0. Total, <=30 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 44. Total, >30-60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 5. Total, >60 msec: Phase 1: LY2603618 + Gemcitabine (n=49): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 2: Electrocardiogram QTc Prolongation [Phase 2: Days 2 and 16 of Cycle 1]. Count Of Participants, Participants. <=30 msec: Phase 2: LY2603618 + Gemcitabine (n=60): 55. >30-60 msec: Phase 2: LY2603618 + Gemcitabine (n=60): 5. >60 msec: Phase 2: LY2603618 + Gemcitabine (n=60): 0.