TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma

NCT02396511 | Completed Phase 2 Results

• 1 other identifier: 105CC201 & 105CC201B
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is effective in the treatment of two patients with metastatic and refractory choriocarcinoma.

Conditions

Choriocarcinoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

  Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma determined according to RECIST 1.1 including measurement of serum β- hCG. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. A 5 mm absolute increase is also required to guard against over calling PD when the total sum is very small.

  Assessed every 8 weeks for up to 35 Months

• Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG

  To determine the Objective Response Rate of two patients with metastatic and refractory choriocarcinoma by RECIST 1.1 including measurement of serum β- hCG. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) categorizes response as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Assessed every 8 weeks for up to 35 Months

Secondary Outcomes (1)

• Frequency and Severity of Adverse Events

  Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.

Study Arms (1)

TRC105 and Bevacizumab

EXPERIMENTAL

TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion

Biological: TRC105; Biological: Bevacizumab

Interventions

TRC105 BIOLOGICAL

weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops

Also known as: Chimeric Antibody (TRC105) to CD105

TRC105 and Bevacizumab

Bevacizumab BIOLOGICAL

Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops

TRC105 and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to consent for self to participate in study
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Measurable disease by RECIST 1.1 and elevated serum β-hCG
• Histologically proven choriocarcinoma that has progressed despite all described lines of chemotherapy for this condition

You may not qualify if:

• Prior treatment with TRC105
• Serious dose-limiting toxicity related to prior bevacizumab
• Current treatment on another therapeutic clinical trial
• Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg)
• Symptomatic pericardial or pleural effusions
• Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks
• Active bleeding or pathologic condition that carries a high risk of bleeding (i.e. hereditary hemorrhagic telangiectasia)
• Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
• Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days
• Known active viral or nonviral hepatitis
• Open wounds or unhealed fractures within 28 days of starting study treatment
• History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (1)

Dana-Farber Cancer Insititue

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Choriocarcinoma

Interventions

carotuximab; Bevacizumab

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Monitor
• Organization: TRACON Pharmaceuticals

ctheuer@traconpharma.com

8585500780

Study Officials

• Charles Theuer, MD

  Medical Monitor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-05

Locations

US (1)