NCT01304303

Brief Summary

Phase I study of SPARC1023 alone and in combination with carboplatin

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

5 years

First QC Date

February 23, 2011

Last Update Submit

May 2, 2019

Conditions

Solid Tumor in Advanced Stage

Keywords

solidtumortaxaneplatinum

Outcome Measures

Primary Outcomes (1)

  • Determination of MTD

    MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.

    One 21-day treatment cycle

Secondary Outcomes (1)

  • Establishing the pharmacokinetic profile

    One 21-day treatment cycle

Study Arms (2)

SPARC1023 I

EXPERIMENTAL
Drug: SPARC1023 I

SPARC1023 II

EXPERIMENTAL
Drug: SPARC1023 II

Interventions

SPARC1023 IDRUG

IV administration

SPARC1023 I
SPARC1023 IIDRUG

IV administration

SPARC1023 II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • ECOG Performance Status ≤ 1.
  • Estimated life expectancy of at least 12-weeks;
  • Measurable disease as per RECIST guideline (Version 1.1);

You may not qualify if:

  • Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPARC Site 1

Buffalo, New York, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 25, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

US(1)