A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer

NCT ID: NCT01995188

Last Updated: 2017-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-16
• Study Completion Date: 2016-11-09

Brief Summary

This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab [Avastin] in three dose expansion cohorts.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation Cohort: DNIB0600A+Carboplatin

DNIB0600A at an initial dose of 1.2 milligrams per kilogram (mg/kg) will be administered via intravenous (IV) infusion further following a dose-escalation until DLT under consultation of the investigator in combination with Carboplatin fixed dose of area under the curve (AUC)=6 mg/milliliter(mL)\*minute (min) administered by IV infusion on Day 1 of a 21-day cycle.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Carboplatin fixed dose of AUC=6 mg/mL\*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first.

DNIB0600A

Intervention Type: DRUG

DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.

NSCLC Dose Expansion Cohort: DNIB0600A+Carboplatin

Recommended phase 2 dose (RP2D) of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL\*min administered via IV infusion on Day 1 of each 21-day cycle in participants with NSCLC until disease progression or death, whichever occurs first.

Group Type: EXPERIMENTAL

DNIB0600A

Intervention Type: DRUG

DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.

PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin

RP2D of DNIB0600A administered via IV infusion in combination with AUC=6 mg/mL\*min administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Carboplatin fixed dose of AUC=6 mg/mL\*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first.

DNIB0600A

Intervention Type: DRUG

DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.

PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin+Bevacizumab

RP2D of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL\*min and Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle until disease progression or death, whichever occurs first.

Carboplatin

Intervention Type: DRUG

Carboplatin fixed dose of AUC=6 mg/mL\*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first.

DNIB0600A

Intervention Type: DRUG

DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.

Interventions

Bevacizumab

Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle until disease progression or death, whichever occurs first.

Intervention Type: DRUG

Carboplatin

Carboplatin fixed dose of AUC=6 mg/mL\*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first.

Intervention Type: DRUG

DNIB0600A

DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.

Intervention Type: DRUG

Other Intervention Names

Avastin

Eligibility Criteria

Inclusion Criteria

• 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.
• PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
• Female participants of childbearing potential must use effective contraception as defined by study protocol and cannot be pregnant or breastfeeding.

• Histological documentation of incurable, locally advanced, or metastatic non-squamous
• NSCLC that has progressed on prior treatment
• Not more than 2 prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within 6 months of recurrence is considered a treatment regimen in the metastatic setting).
• For participants with a documented epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement, one additional line of non-cytotoxic prior treatment will be permitted provided the therapy is a targeted agent against the EGFR mutation or ALK rearrangement.
• For participants with lung cancer, centrally confirmed high expression of a sodium-dependent phosphate transporter (NaPi2b) by immunohistochemistry (IHC) is required (i.e., IHC 2+ or 3+).

Exclusion Criteria

• Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1.
• For ovarian cancer participants only, platinum-based chemotherapy within 6 months prior to Day 1.
• For ovarian cancer participants only, platinum treatment with more than two platinum-based chemotherapy regiments or more than four anti-cancer regimens, overall, for the treatment of ovarian cancer.
• 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 human immunodeficiency virus (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 central nervous system (CNS) metastases.
• Prior treatment with NaPi2b- targeted therapy.

Expansion Cohort Only):

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Massachusetts General Hospital.

Boston, Massachusetts, United States

Dana Farber Cancer Inst.

Boston, Massachusetts, United States

The University of Oklahoma

Oklahoma City, Oklahoma, United States

The Sarah Cannon Research Inst

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

GO29006

Identifier Type: -

Identifier Source: org_study_id