Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors

NCT00731861 | Completed Phase 1 DMC

• 1 other identifier: 0412-21/ IUCRO-0101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.

Conditions

Neoplasm Metastasis; Carcinoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787

  Baseline through End of Study

Secondary Outcomes (1)

• To evaluate the pharmacokinetics of paclitaxel alone and in combination with PTK787 from patients with cancer accrued to this study

  Baseline through End of Study

Study Arms (1)

1

EXPERIMENTAL

Paclitaxel plus PTK787

Drug: Paclitaxel plus PTK787

Interventions

Paclitaxel plus PTK787 DRUG

Paclitaxel will be given on days 1 and 15 over 28 days in cycle 1 with PTK787 on days 3 to 28. PTK787 WILL BE TAKEN AT NIGHT. In cycle 2 and beyond, paclitaxel will be given on days 1, 8 and 15 every 28 days . PTK787 will be taken orally NIGHTLY.

1

Eligibility Criteria

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

You may qualify if:

• Adult patients with histologically confirmed malignancy that is unresponsive to curative therapy and for which no conventional therapy exists
• ECOG Performance Status 0-2
• Measurable or evaluable disease
• Laboratory values within protocol limits within 2 weeks prior to registration
• Life expectancy ≥ 12 weeks
• Patient or guardian must have written informed consent obtained according to local guidelines
• Women of child-bearing potential (non-sterile) must use appropriate barrier contraception for duration of study (negative pregnancy test required at baseline). Oral contraceptives will not be an acceptable form of contraception
• Patients may have received prior standard taxane therapy, but have never progressed on taxane-based therapy.

You may not qualify if:

• History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
• Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
• Prior biologic or immunotherapy ≤ 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
• Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization.
• Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization. Minor surgery ≤ 2 weeks prior to randomization.
• Patients who have received investigational drugs ≤ 4 weeks prior to registration
• Prior therapy with anti-VEGF agents
• Peripheral neuropathy with functional impairment ≥ CTC grade 2 neuropathy, regardless of causality
• Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
• Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
• Patient agrees to avoid grapefruit (juice and fruit)
• Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
• Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
• Unstable angina pectoris
• Congestive heart failure greater than NYHA classification ≥ Grade 1 (can be controlled with medication)

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Novartis: collaborator

Study Sites (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma

Interventions

Paclitaxel; vatalanib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Gabriela Chiorean, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: May 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: August 1, 2010
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

US (1)