NCT01305512

Brief Summary

Evaluation of pharmacokinetic profile of SPARC1028

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2012

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 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

4.1 years

First QC Date

February 24, 2011

Last Update Submit

May 2, 2019

Conditions

Solid Tumor in Advanced Stage

Keywords

SolidTumorTaxane

Outcome Measures

Primary Outcomes (1)

  • Determination of Maximum Tolerated Dose (MTD) during dose escalation

    MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects

    One 21-day treatment cycle

Secondary Outcomes (1)

  • Establishing pharmacokinectic profile at each dose level for SPARC1028

    One 21-day treatment cycle

Study Arms (1)

SPARC1028

EXPERIMENTAL
Drug: SPARC1028

Interventions

SPARC1028DRUG

SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest

SPARC1028

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
  • Age ≥18 years
  • ECOG Performance Status ≤ 1.
  • Estimated life expectancy of at least 12-weeks;

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 28, 2011

Study Start

May 1, 2012

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

US(1)