A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Patients With Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01995188
First received: November 15, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This open-label, multicenter, phase 1b study will evaluate the safety and pharma cokinetics of DNIB0600A in patients with platinum-sensitive ovarian cancer. The maximum tolerated dose of intravenously infused DNIB0600A in combination with ca rboplatin will be determined in escalating dose cohorts. The combination of DNIB 0600A and carboplatin will then be evaluated with and without bevacizumab [Avast in] in two dose expansion cohorts.


Condition Intervention Phase
Ovarian Cancer
Drug: DNIB0600A
Drug: carboplatin
Drug: bevacizumab [Avastin]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of DNIB0600A in Combination With Carboplatin (With or Without Bevacizumab) in Patients With Platinum-Sensitive Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AE) [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
  • Incidence of anti-DNIB0600A antibodies [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration-time curve (AUC) of DNIB0600A [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Objective response determined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: More than 4 weeks after baseline evaluation ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Cohorts Drug: DNIB0600A
Escalating doses of intravenously administered DNIB0600A
Drug: carboplatin
An IV infusion at a dose of AUC 6 mg/mL * min
Experimental: Dose Expansion Cohort with bevacizumab [Avastin] Drug: DNIB0600A
Intravenous administration of a fixed dose of DNIB0600A
Drug: carboplatin
An IV infusion at a dose of AUC 6 mg/mL * min
Drug: bevacizumab [Avastin]
IV infusion at 15 mg/kg
Experimental: Dose Expansion Cohort without bevacizumab [Avastin] Drug: DNIB0600A
Intravenous administration of a fixed dose of DNIB0600A
Drug: carboplatin
An IV infusion at a dose of AUC 6 mg/mL * min

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
  • Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive.
  • Platinum-sensitive ovarian cancer with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
  • Available tumor specimen.
  • Measurable disease.
  • Female patients of childbearing potential must use effective contraception as defined by study protocol and cannot be pregnant or breastfeeding.

Exclusion Criteria:

  • Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1.
  • Platinum-based chemotherapy within 6 months prior to Day 1.
  • Palliative radiation within 2 weeks prior to Day 1.
  • Toxicity (except alopecia and anorexia) from prior therapy or neuropathy of grades > 1.
  • Evidence of any significant disease or condition that could affect compliance with the protocol or interpretation of results.
  • Known active infection (except fungal nail infections).
  • History of liver disease or HIV.
  • Other malignancy within the last 5 years, except for adequately treated or controlled carcinoma in situ of the cervix or skin cancer or primary endometrial cancer of stage </= 1B.
  • Untreated or active CNS metastases.
  • Prior treatment with NaPi2b- targeted therapy.

Bevacizumab [Avastin]-Specific Exclusion Criteria:

  • Inadequately controlled hypertension or history of hypertensive crisis or encephalopathy.
  • History of heart problems or thrombosis within 6 months prior to study start.
  • History of stroke within 6 months prior to study enrollment.
  • History of significant vascular disease.
  • History of expectoration of blood within 1 month prior to study start or blood clotting problems.
  • Core biopsy or other minor surgical procedure within 7 days prior to study start
  • Serious and non-healing wound, active ulcer, or untreated bone fracture.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995188

Contacts
Contact: Reference Study ID Number: GO29006 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01995188     History of Changes
Other Study ID Numbers: GO29006
Study First Received: November 15, 2013
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014