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Colon Cancer

Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer

Sponsored by ARCA Biopharma, Inc.

About this trial

Last updated 17 years ago

Study ID

NAP-0601

Status

Suspended

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 19 years ago

What is this trial about?

This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This trial will be performed to initiate identification of a safe and effective dose of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-FU-based chemotherapy.

What are the Participation Requirements?

- Tissue diagnosis of adenocarcinoma of the colon or rectum

- Documented metastatic disease with at least one measurable lesion by RECIST criteria

- Previously treated with 5-FU-based chemotherapy in the form of FOLFIRI, FOLFOX, or
XELOX plus bevacizumab as first-line chemotherapy and have recorded progressive
disease during treatment or after discontinuation of treatment, when discontinuation
of treatment occurred less than 6 months before enrollment (Stage I) or
randomization (Stage II)

- Estimated life expectancy of at least 6 months

- Age 18 to 75 years

- Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before
enrollment

- No other active malignancy for which the subject is currently receiving treatment
(other than mCRC)

- No ongoing therapy with or need for parenteral and oral antithrombotics including
anticoagulants and anti-platelet agents (including aspirin) and thrombolytics

- No contraindication to systemic anticoagulation

- No contraindication to modified FOLFOX6 or FOLFIRI combination chemotherapy

- No receipt of any investigational compound within 28 days of enrollment

Locations

Location

Status