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A Phase 1 Pharmacokinetic and Safety Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) Alone and in Combination With Carboplatin in Subjects With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor in Advanced Stage

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Trial Information

A Phase 1 Pharmacokinetic and Safety Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) Alone and in Combination With Carboplatin in Subjects With Advanced Solid Malignancies


This is a phase I study of PICN alone and in combination with carboplatin in subjects with
advanced solid malignancies. It will be conducted as a two-part study (Part A followed by
Part B).

Part A will characterize the pharmacokinetic profile of PICN at 3 dose levels administered
as 30-min infusion to separate groups of 3 subjects.

Part B will start upon completion of Part A and will use the standard '3+3' dose-escalation
design to determine the Maximum Tolerated Dose (MTD) and recommend phase II dose of PICN in
combination with carboplatin. Both PICN and carboplatin will be administered on day 1 and
will repeat every 3 weeks (1 cycle). Carboplatin dose is fixed at AUC 6 and PICN will be
administered at escalating doses till Dose Limiting Toxicity (DLT) is observed. The dose
escalation plan is as follows: 3 subjects will be treated at the initial dose level for PICN
with carboplatin at AUC 6. If no cycle-1 dose-limiting toxicities (DLTs) are observed, 3
additional subjects will be treated at the next dose level. If one of 3 subjects experiences
a DLT at any given dose level, 3 additional subjects will be treated at that same dose. If a
DLT occurred in at least 2 subjects at any dose level, dose escalation will be halted, and
the next 3 subjects enrolled will be treated at the preceding lower dose level. MTD will be
defined as the dose below which DLT is seen for ≥ 2 subjects in cycle 1. At least 6
subjects will be treated at the MTD. Subjects who fail to complete 1 cycle of study
treatment for non-treatment related reasons will be replaced.

AEs will be monitored across all cycles per CTCAE. Subjects will continue therapy until
disease progression, development of unacceptable toxicities, non-compliance, intercurrent
illness that prevents treatment continuation, withdrawal of consent, or change in subject
condition that render the subject unacceptable for further treatment. Upon study completion,
subjects will be followed for toxicities for 4 weeks, or longer if there are unresolved ≥
grade 3 toxicities at the end of the 4-week period. Subjects removed from study for
unacceptable adverse events will be followed until resolution (≤ grade 2) or stabilization
of the adverse events. Blood samples for PK studies will be collected at pre-planned
time-points.


Inclusion Criteria:



- Part A: Histologically or cytologically confirmed diagnosis of solid tumor in
advanced stage which taxane-based therapy is a rational treatment option. Part B:
Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage
which platinum/taxane-based combination therapy is a rational treatment option.

- Age ≥18 years

- ECOG Performance Status ≤ 1.

- Estimated life expectancy of at least 12-weeks;

- Measurable disease as per RECIST guideline (Version 1.1);

- Adequate organ and immune system function as indicated by laboratory tests obtained ≤
2 weeks prior to dosing.

- Women of child bearing potential practicing an acceptable method of birth control.

- Willing to participate and give written informed consent.

Exclusion Criteria:

- Any malignancy within past 5-years, except non-melanoma skin cancer, cervical
intraepithelial neoplasia (CIN), or in situ cervical cancer (CIS)

- Known hypersensitivity to the study drugs

- Treatment with any anti-cancer agents within 28 days of study entry

- Presence of clinically evident active CNS metastases, including leptomeningeal
involvement, requiring steroid or radiation therapy

- Pre-existing peripheral neuropathy (grade 1 or higher)

- Any other severe concurrent disease which in the judgment of the investigator would
make the subject inappropriate for entry into this study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of MTD

Outcome Description:

MTD for PICN in combination with carboplatin will be determined. MTD will be defined as the PICN dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.

Outcome Time Frame:

One 21-day treatment cycle

Safety Issue:

Yes

Principal Investigator

Wen Wee Ma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistant Professor, Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CLR_10_23

NCT ID:

NCT01304303

Start Date:

December 2011

Completion Date:

October 2013

Related Keywords:

  • Solid Tumor in Advanced Stage
  • solid
  • tumor
  • taxane
  • platinum

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263