NCT02597465

Brief Summary

An open label study to determine the efficacy and safety of SPARC1507

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
3.1 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

November 3, 2015

Last Update Submit

December 10, 2020

Conditions

Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1

    3 years and 6 months

Secondary Outcomes (3)

  • Overall survival in subjects treated with SPARC1507 versus Investigators choice

    3 years and 6 months

  • Overall response rate in subjects treated with PICN versus Investigators choice

    3 years and 6 months

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    3 years and 6 months

Study Arms (2)

SPARC1507

EXPERIMENTAL

SPARC1507

Drug: SPARC1507

Chemotherapy

EXPERIMENTAL

Chemotherapy

Drug: Reference1507

Interventions

SPARC1507DRUG

The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle

SPARC1507
Reference1507DRUG

Investigators choice including chemotherapy or supportive therapy

Chemotherapy

Eligibility Criteria

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

You may qualify if:

  • Evidence of advanced/metastatic biliary tract cancer
  • Male or female ≥ 18 years old
  • Participants must have measurable disease according to RECIST
  • ECOG performance status ≤ 1

You may not qualify if:

  • Known hypersensitivity to trial treatments, or their excipients
  • Prior history of treatment with any taxane therapy
  • Cardiovascular disorders as per Investigator's discretion
  • The subject has received radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPARC study site

Aurora, Colorado, 80045, United States

Location
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 5, 2015

Study Start

December 1, 2018

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

US(1)