Phase I of Carboplatin-Olaparib Followed by Olaparib Monotherapy in Advanced Cancer

Phase 1

Completed

• Conditions: Breast Cancer; Ovarian Cancer; Advanced Cancer
• Interventions: Drug: carboplatin, olaparib

• Registration Number: NCT02418624
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib.

Detailed Description

A 3+3 dose escalation trial of 2 cycles (21 days) carboplatin and olaparib combination therapy, followed by olaparib monotherapy until progression or unacceptable toxicity in patients with advanced cancer.

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Study Start: 2015-05
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation	carboplatin, olaparib	carboplatin, olaparib

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	per doselevel of 3 to 6 patients (when 3-6 patients have completed DLT period of 3 weeks)	The dose level at which more than 1/6 patients develop a dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PAR (Poly(ADP) ribose) activation measured with the PAR assay)	1 year	PAR (Poly(ADP) ribose) activation measured with the PAR assay
Objective Response Rate	1 year	Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Pharmacokinetics (area under time-concentration curve (AUC))	1 year	Pharmacokinetics (PK) measurements of olaparib alone and olaparib in combination with carboplatin

Trial Locations

Locations (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands