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Clinical Trials/NCT01676753
NCT01676753CompletedPhase 1

A Phase 1b Trial of the Cyclin-dependent Kinase Inhibitor Dinaciclib in Combination With Pembrolizumab in Patients With Advanced Breast Cancer and Assessment of MYC Oncogene Overexpression

Jo Chien1 site in 1 country32 target enrollmentStarted: December 28, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
32
Locations
1
Primary Endpoint
Proportion of participants with reported dose-limiting toxicities (DLTs)

Study Overview

Brief Summary

The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients with metastatic or locally advanced and unresectable triple negative breast cancer, to evaluate the efficacy of combined dinaciclib and pembrolizumab.

Detailed Description

PRIMARY OBJECTIVE:

I. Define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of dinaciclib

SECONDARY OBJECTIVE:

I. Evaluation of the preliminary efficacy of this combination using RECIST 1.1 and irRECIST.

EXPLORATORY OBJECTIVE:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Treatment (Dinaciclib, Pembrolizumab)

Experimental

Pembrolizumab will be administered on Day 1, every 3 weeks at a fixed dose of 200 mg IV. Dinaciclib will be administered D1 and D8 of a 21 day cycle by 2-hour intravenous infusion starting at Dose Level (DL) 1 of 12 mg/m^2. Further dose escalation cohorts are defined as follows: DL 2: 18 mg/m^2, DL 3: 25 mg/m^2, DL 4: 33 mg/m^2, and DL 5: 50 mg/m^2

Intervention: Dinaciclib (Drug)

Treatment (Dinaciclib, Pembrolizumab)

Experimental

Pembrolizumab will be administered on Day 1, every 3 weeks at a fixed dose of 200 mg IV. Dinaciclib will be administered D1 and D8 of a 21 day cycle by 2-hour intravenous infusion starting at Dose Level (DL) 1 of 12 mg/m^2. Further dose escalation cohorts are defined as follows: DL 2: 18 mg/m^2, DL 3: 25 mg/m^2, DL 4: 33 mg/m^2, and DL 5: 50 mg/m^2

Intervention: Pembrolizumab (Drug)

Outcomes

Primary Outcomes

Proportion of participants with reported dose-limiting toxicities (DLTs)

Time Frame: Up to 1 cycle (1 cycle is equal to 21 days)

Dose-limiting hematologic and non-hematologic toxicities classified using the CTCAE, will be based on events occurring during the first cycle of study drug administration. To be considered a dose-limiting toxicity, an adverse experience must be related to one or both of the study drugs, and must not be related to disease progression or intercurrent illnesses. Participants must receive Day 1 and Day 8 treatments of dinaciclib during the first cycle in order to be evaluable for DLTs (unless missed doses are due to toxicity).

Maximum tolerated dose (MTD)

Time Frame: Up to 1 cycle (1 cycle is equal to 21 days)

The MTD is determined by the number of dose-limiting toxicities reported by participants in the first cycle of treatment.

Secondary Outcomes

  • Overall Response Rate(Up to 3 years)

Investigators

Sponsor
Jo Chien
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jo Chien

UCSF Assistant Clinical Professor

University of California, San Francisco

Study Sites (1)

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